A Twelve Week Study of Supervised Mouth Rinse and Flossing

Pilot Study: Twelve Week Clinical Efficacy of Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis

Sponsors

Lead Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Source Johnson & Johnson Consumer and Personal Products Worldwide
Brief Summary

The purpose of this study is to evaluate the efficacy of twice daily alcohol containing essential oil mouth rinse and brushing versus dental flossing and brushing under once daily supervision for the prevention and reduction of plaque and gingivitis.

Overall Status Completed
Start Date 2018-09-26
Completion Date 2018-12-21
Primary Completion Date 2018-12-21
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Interproximal Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use 12 Weeks
Interproximal Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use 12 Weeks
Secondary Outcome
Measure Time Frame
Interproximal Mean Turesky Plaque Index (TPI) Score After 4 Weeks of Product use 4 Weeks
Interproximal Mean Modified Gingival Index (MGI) Score After 4 Weeks of Product use 4 Weeks
Whole-mouth Mean Turesky Plaque Index (TPI) Score After 4 Weeks and 12 Weeks of Product use 4 Weeks and 12 Weeks
Whole-mouth Mean Modified Gingival Index (MGI) Score After 4 Weeks and 12 Weeks of Product use 4 Weeks and 12 Weeks
Whole-mouth and Interproximal Mean Bleeding Index (BI) After 4 and 12 Weeks of Product use 4 Weeks and 12 Weeks
Whole-mouth and Interproximal Percent Bleeding Sites, Based on the BI Score After 4 and 12 Weeks of Product use 4 Weeks and 12 Weeks
Interproximal of the Proximal Marginal Plaque Index Score After 4 and 12 Weeks 4 Weeks and 12 Weeks
Enrollment 149
Condition
Intervention

Intervention Type: Other

Intervention Name: Colgate Cavity Protection Toothpaste

Description: Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.

Intervention Type: Other

Intervention Name: American Dental Association (ADA) Referenced Toothbrush

Description: Participants will brush teeth at least one minute with provided toothbrush twice daily.

Intervention Type: Other

Intervention Name: 5% Hydroalcohol Mouth Rinse

Description: Participants use 20 mL of 5% Hydroalcohol mouth rinse as negative control for 30 sec twice a day after brushing.

Arm Group Label: Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse)

Intervention Type: Other

Intervention Name: REACH Dental Floss

Description: Participants after brushing, rinse mouth with water and floss using Reach dental floss once a day.

Intervention Type: Other

Intervention Name: Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed)

Description: Participants after brushing, rinse with 20mL of the AEO mouth rinse for 30 seconds twice a day.

Arm Group Label: Group 1: Listerine Cool Mint Mouth Rinse (Marketed product)

Eligibility

Criteria:

Inclusion criteria: - Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products according to instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment - Able to attend once daily session during weekdays for flossing and rinsing occurring on site - Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial - Able to read and understand the local language (participants capable of reading the documents) - Adequate oral hygiene (that is brush teeth daily and exhibit no signs or oral neglect) - A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count - A minimum of 10 bleeding sites based on the BI - Absence of advanced periodontitis based on a clinical examination at Baseline and discretion of the dental examiner Exclusion criteria: - History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye - Dental prophylaxis within four weeks prior to Screening/Baseline visit - History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures - Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the Investigator - Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride, stannous fluoride or chlorhexidine containing mouth rinses within the two weeks prior to Baseline

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Jeffery Milleman, DDS Principal Investigator Salus Research, Inc.
Location
Facility: Salus Research, Inc.
Location Countries

United States

Verification Date

2020-12-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 4
Arm Group

Label: Group 1: Listerine Cool Mint Mouth Rinse (Marketed product)

Type: Experimental

Description: Participants will receive Alcohol-containing Essential Oil (AEO) containing mouth rinse (Listerine Cool Mint, marketed) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home.

Label: Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse)

Type: Experimental

Description: Participants will receive negative control mouth rinse (5% Hydroalcohol mouth rinse) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home.

Label: Group 3: Flossing Performed by Dental Hygienist

Type: Experimental

Description: Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Dental hygienist will floss participant's teeth at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.

Label: Group 4: Flossing under Supervision

Type: Experimental

Description: Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Participants floss their teeth under supervision at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Other

Masking: Double (Participant, Care Provider)

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