- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01009554
Oral Tissue Tolerance of a Mouthrinse
June 4, 2015 updated by: Johnson & Johnson Consumer and Personal Products Worldwide
Assessment of the Oral Tissue Tolerance of a Potassium Oxalate Containing Mouthrinse
This study is 8 weeks long.
People participating in this study will be asked to brush their teeth two times a day.
Some people will get a mouthwash.
People with a mouthwash will rinse two times a day after brushing their teeth.
The mouth, teeth, tongue and gums will be looked at by a dentist.
The dentist will look at the mouth to make sure the mouthwash does not irritate the mouth.
The dentist will also look at the color of the teeth and amount of stain on the front teeth.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an 8-week, randomized, observer-blind, controlled, parallel group clinical study design to assess the oral tissue tolerance of a potassium oxalate containing mouthrinse.
Subjects will have their oral soft/hard tissues assessed and will be evaluated for stain levels and tooth color shades at Screening/Baseline (Visit 1), Week 4 (Visit 2), Week 6 (Visit 3) and Week 8 (Visit 4).
Subjects will be instructed to brush their teeth two times daily in their usual manner using the provided sodium fluoride toothpaste.
Subjects assigned to the mouthrinse group will be instructed to rinse twice daily after brushing.
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Paramus, New Jersey, United States, 07652
- TKL Reearch, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females at least 18 years of age and in good general and oral health.
- Volunteers must read, sign, and receive a signed copy of the Informed Consent Form after the nature of the study has been fully explained.
- Willingness to use the assigned products according to instructions, availability for appointments and likelihood of completing the study.
- Willingness to refrain from using any breath freshener products or unassigned oral care products (i.e., oral care strips, candy-type mints, sprays, chewing gums, throat lozenges, cough drops, mouthwashes or teeth whitening products) throughout the duration of the study.
- Willingness to refrain from using any whitening products and smokeless tobacco products within one week prior to and for the duration of the study, in order to reduce alternate sources of potential irritation.
- A minimum of 16 natural teeth, including at least 10 of the 12 anterior teeth (#6-11, #22-27, however, #7-10 must be present), with scorable facial and lingual surfaces. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars will not be included in the tooth count.
- Classic Vita® Shade minimum value of A2 or darker on at least 2 of the 4 maxillary anterior teeth (#7-10).
- Absence of abnormal or severely fissured tongue, geographic tongue, tongue piercing or any obvious tongue abnormalities that may interfere with the assessment of oral irritation.
- Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
- Absence of neglected dental health (i.e. gross calculus deposits or rampant caries based on visual examination), significant oral soft tissue pathology, systemically-related gingival enlargement, tissue damage due to ill-fitting appliances or restoration, or extreme crowding or overlapping of teeth
Exclusion Criteria:
- Physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, etc.).
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses.
- History or current evidence of significant oral soft tissue pathology, excluding gingivitis, based on the dentist's visual examination and at the discretion of the investigator.
- Prior participation in any oral hygiene or product clinical study within the previous 30 days.
- Therapy with any medications, currently or within the last 30 days, which might interfere with the outcome of the study by affecting tooth color or stain formation (i.e., certain antimicrobial mouthrinses and antibiotics, such as chlorhexidine).
- Restorations on 10% or more of the facial surfaces of the maxillary anterior incisor teeth.
- Dental fluorosis, hypoplasia, restorations, tetracycline stains, or other enamel surface irregularities that may interfere with evaluation of the selected teeth.
- Visual evidence of Moderate/advanced periodontitis (ADA Type III, IV). Orthodontic bands, appliances, bridges, numerous crowns, removable orthodontic appliances or partial dentures.
- Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
- Regular use of whitening products within 1 week prior to Screening/Baseline. Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial result and, in the judgment of the investigator, would make the subject inappropriate for the entry into this trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Potassium Oxylate
1.5% potassium oxalate sensitive mouthwash
|
Rinse with 10 mL for 60 seconds, twice daily after brushing in usual manner with a sodium fluoride dentifrice
Other Names:
|
Active Comparator: Sodium Fluoride
Sodium Fluoride Dentifrice
|
Brush in usual manner, twice daily, with a sodium fluoride dentifrice
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment
Time Frame: 8 weeks
|
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System.
Assessments were made under standardized lighting conditions after participants brushed their teeth with water.
The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system.
The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively.
An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2.
The ΔE was calculated per tooth and then averaged over the teeth for a participant.
|
8 weeks
|
Oral Tissue Tolerance
Time Frame: through 8 weeks
|
Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely.
If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event.
|
through 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment
Time Frame: 4 weeks
|
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System.
Assessments were made under standardized lighting conditions after participants brushed their teeth with water.
The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system.
The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively.
An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2.
The ΔE was calculated per tooth and then averaged over the teeth for a participant.
|
4 weeks
|
Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment
Time Frame: 6 weeks
|
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System.
Assessments were made under standardized lighting conditions after participants brushed their teeth with water.
The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system.
The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively.
An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2.
The ΔE was calculated per tooth and then averaged over the teeth for a participant.
|
6 weeks
|
Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment
Time Frame: 4 weeks
|
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System.
Assessments were made under standardized lighting conditions after participants brushed their teeth with water.
The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system.
The change in the individual L* color parameter was calculated.
The ΔL was calculated per tooth and then averaged over the teeth for a participant.
|
4 weeks
|
Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment
Time Frame: 6 weeks
|
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System.
Assessments were made under standardized lighting conditions after participants brushed their teeth with water.
The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system.
The change in the individual L* color parameter was calculated.
The ΔL was calculated per tooth and then averaged over the teeth for a participant.
|
6 weeks
|
Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment
Time Frame: 8 weeks
|
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System.
Assessments were made under standardized lighting conditions after participants brushed their teeth with water.
The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system.
The change in the individual L* color parameter was calculated.
The ΔL was calculated per tooth and then averaged over the teeth for a participant.
|
8 weeks
|
Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment
Time Frame: 4 weeks
|
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System.
Assessments were made under standardized lighting conditions after participants brushed their teeth with water.
The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system.
The change in the individual b* color parameter was calculated.
The Δb was calculated per tooth and then averaged over the teeth for a participant.
|
4 weeks
|
Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment
Time Frame: 6 weeks
|
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System.
Assessments were made under standardized lighting conditions after participants brushed their teeth with water.
The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system.
The change in the individual b* color parameter was calculated.
The Δb was calculated per tooth and then averaged over the teeth for a participant.
|
6 weeks
|
Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment
Time Frame: 8 weeks
|
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System.
Assessments were made under standardized lighting conditions after participants brushed their teeth with water.
The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system.
The change in the individual b* color parameter was calculated.
The Δb was calculated per tooth and then averaged over the teeth for a participant.
|
8 weeks
|
Mean Stain Score Over All Tooth Sites at 4 Weeks
Time Frame: 4 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area and intensity according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
4 weeks
|
Mean Stain Score Over All Tooth Sites at 6 Weeks
Time Frame: 6 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area and intensity according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
6 weeks
|
Mean Stain Score Over All Tooth Sites at 8 Weeks
Time Frame: 8 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area and intensity according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
8 weeks
|
Mean Stain Intensity Over All Tooth Sites at 4 Weeks
Time Frame: 4 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
4 weeks
|
Mean Stain Intensity Over All Tooth Sites at 6 Weeks
Time Frame: 6 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
6 weeks
|
Mean Stain Intensity Over All Tooth Sites at 8 Weeks
Time Frame: 8 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
8 weeks
|
Mean Stain Area Over All Tooth Sites at 4 Weeks
Time Frame: 4 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
|
4 weeks
|
Mean Stain Area Over All Tooth Sites at 6 Weeks
Time Frame: 6 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
|
6 weeks
|
Mean Stain Area Over All Tooth Sites at 8 Weeks
Time Frame: 8 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
|
8 weeks
|
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks
Time Frame: 4 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
4 weeks
|
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks
Time Frame: 6 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
6 weeks
|
Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks
Time Frame: 8 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
8 weeks
|
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks
Time Frame: 4 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The interproximal (mesial and distal) regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
4 weeks
|
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks
Time Frame: 6 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The interproximal (mesial and distal) regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
6 weeks
|
Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks
Time Frame: 8 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The interproximal (mesial and distal) regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
8 weeks
|
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks
Time Frame: 4 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The interproximal (mesial and distal) regions were scored for area according to the following criteria.
Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
|
4 weeks
|
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks
Time Frame: 6 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The interproximal (mesial and distal) regions were scored for area according to the following criteria.
Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
|
6 weeks
|
Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks
Time Frame: 8 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The interproximal (mesial and distal) regions were scored for area according to the following criteria.
Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
|
8 weeks
|
Mean Stain Score for Gingival Sites at 4 Weeks
Time Frame: 4 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
4 weeks
|
Mean Stain Score for Gingival Sites at 6 Weeks
Time Frame: 6 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
6 weeks
|
Mean Stain Score for Gingival Sites at 8 Weeks
Time Frame: 8 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
8 weeks
|
Mean Stain Intensity for Gingival Sites at 4 Weeks
Time Frame: 4 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The gingival regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
4 weeks
|
Mean Stain Intensity for Gingival Sites at 6 Weeks
Time Frame: 6 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The gingival regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
6 weeks
|
Mean Stain Intensity for Gingival Sites at 8 Weeks
Time Frame: 8 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The gingival regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
8 weeks
|
Mean Stain Area for Gingival Sites at 4 Weeks
Time Frame: 4 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The gingival regions were scored for area according to the following criteria.
Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
|
4 weeks
|
Mean Stain Area for Gingival Sites at 6 Weeks
Time Frame: 6 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The gingival regions were scored for area according to the following criteria.
Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
|
6 weeks
|
Mean Stain Area for Gingival Sites at 8 Weeks
Time Frame: 8 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The gingival regions were scored for area according to the following criteria.
Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.
|
8 weeks
|
Mean Stain Score for Body Sites at 4 Weeks
Time Frame: 4 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
4 weeks
|
Mean Stain Score for Body Sites at 6 Weeks
Time Frame: 6 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
6 weeks
|
Mean Stain Score for Body Sites at 8 Weeks
Time Frame: 8 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
8 weeks
|
Mean Stain Intensity for Body Sites at 4 Weeks
Time Frame: 4 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The body regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
4 weeks
|
Mean Stain Intensity for Body Sites at 6 Weeks
Time Frame: 6 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The body regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
6 weeks
|
Mean Stain Intensity for Body Sites at 8 Weeks
Time Frame: 8 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The body regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
8 weeks
|
Mean Stain Area for Body Sites at 4 Weeks
Time Frame: 4 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The body regions were scored for area according to the following criteria.
Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
|
4 weeks
|
Mean Stain Area for Body Sites at 6 Weeks
Time Frame: 6 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The body regions were scored for area according to the following criteria.
Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
|
6 weeks
|
Mean Stain Area for Body Sites at 8 Weeks
Time Frame: 8 weeks
|
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
The body regions were scored for area according to the following criteria.
Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
|
8 weeks
|
Mean Stain Score for Facial Sites at 4 Weeks
Time Frame: 4 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area and intensity according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
4 weeks
|
Mean Stain Score for Facial Sites at 6 Weeks
Time Frame: 6 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area and intensity according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
6 weeks
|
Mean Stain Score for Facial Sites at 8 Weeks
Time Frame: 8 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area and intensity according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
8 weeks
|
Mean Stain Intensity for Facial Sites at 4 Weeks
Time Frame: 4 weeks
|
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
4 weeks
|
Mean Stain Intensity for Facial Sites at 6 Weeks
Time Frame: 6 weeks
|
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
6 weeks
|
Mean Stain Intensity for Facial Sites at 8 Weeks
Time Frame: 8 weeks
|
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
8 weeks
|
Mean Stain Area for Facial Sites at 4 Weeks
Time Frame: 4 weeks
|
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
|
4 weeks
|
Mean Stain Area for Facial Sites at 6 Weeks
Time Frame: 6 weeks
|
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
|
6 weeks
|
Mean Stain Area for Facial Sites at 8 Weeks
Time Frame: 8 weeks
|
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
|
8 weeks
|
Mean Stain Score for Lingual Sites at 4 Weeks
Time Frame: 4 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area and intensity according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
4 weeks
|
Mean Stain Score for Lingual Sites at 6 Weeks
Time Frame: 6 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area and intensity according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
6 weeks
|
Mean Stain Score for Lingual Sites at 8 Weeks
Time Frame: 8 weeks
|
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored.
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area and intensity according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected).
The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).
|
8 weeks
|
Mean Stain Intensity for Lingual Sites at 4 Weeks
Time Frame: 4 weeks
|
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
4 weeks
|
Mean Stain Intensity for Lingual Sites at 6 Weeks
Time Frame: 6 weeks
|
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
6 weeks
|
Mean Stain Intensity for Lingual Sites at 8 Weeks
Time Frame: 8 weeks
|
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for intensity according to the following criteria.
The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle.
All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).
|
8 weeks
|
Mean Stain Area for Lingual Sites at 4 Weeks
Time Frame: 4 weeks
|
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
|
4 weeks
|
Mean Stain Area for Lingual Sites at 6 Weeks
Time Frame: 6 weeks
|
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
|
6 weeks
|
Mean Stain Area for Lingual Sites at 8 Weeks
Time Frame: 8 weeks
|
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index.
Each surface was divided into 4 regions (gingival, mesial, distal, and body).
All four regions were scored for area according to the following criteria.
Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
November 5, 2009
First Submitted That Met QC Criteria
November 5, 2009
First Posted (Estimate)
November 6, 2009
Study Record Updates
Last Update Posted (Estimate)
July 3, 2015
Last Update Submitted That Met QC Criteria
June 4, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNKPLT0002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dental Health
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KDH Research & CommunicationCompleted
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Temple UniversityUniversity of Michigan; National Institute of Dental and Craniofacial Research... and other collaboratorsCompletedDental Caries | Oral Hygiene | Oral Health | Dental HealthUnited States
-
NORCE Norwegian Research Centre ASUniversity of Bergen; University of Witten/Herdecke; National Research Centre...CompletedHealth Complaints Attributed to Dental Amalgam RestorationsNorway
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Kuwait UniversityUniversity of TurkuCompleted
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Istanbul Medipol University HospitalEnrolling by invitationOral Health | Periodontal IndexesTurkey
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Boston UniversityNational Institute of Dental and Craniofacial Research (NIDCR)CompletedHealth Behavior | Caries, DentalUnited States
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Unilever R&DWorld Dental Federation (FDI)CompletedDental Plaque | Behavior | Behavior, HealthIndonesia, Nigeria
-
University of BrasiliaCharite University, Berlin, GermanyTerminatedDental Caries | Oral Health | Dental Atraumatic Restorative TreatmentBrazil
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ASST Santi Paolo e CarloCompletedDental Implant | Marginal Bone Loss | Peri Implant Health | Supral Tissue HeightItaly
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University of Illinois at ChicagoNational Institute of Dental and Craniofacial Research (NIDCR)CompletedDental Caries in Children | Health Behavior | Healthcare DisparitiesUnited States
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Rennes University HospitalNot yet recruiting
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University of Santiago de CompostelaLacer, S.A.CompletedHealthy | Dental PlaqueSpain
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Cairo UniversityUnknown
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Sri Hasanamba Dental College and HospitalUnknown
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Cairo UniversityCompletedHigh Caries Risk Patients | Streptococcus MutansEgypt
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National University of MalaysiaCompletedXerostomia | Dry MouthMalaysia
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Fabio Correia SampaioCompleted