- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03219840
Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis
Effects of Cetylpyridium Chloride (CPC) Based Chewing Gum Plus Tooth Brushing on Plaque Formation and Gingivitis: a Randomized, Double-Blind, Crossover, Placebo-controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77054
- The University of Texas Health Science Center at Houston
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be aged 18 and older
- Be capable of giving informed consent themselves and are able and willing to participate in the study
- Patients willing to forgo any optional dental procedures during the study period, such as dental prophylaxis or teeth whitening
- Patients that regularly brush their teeth twice a day
Exclusion Criteria:
- Pregnant or breastfeeding women
- Patients taking long-term anti-microbial or anti-inflammatory drugs
- Patients unable or unwilling to provide informed consent
- Self-reported use of tobacco products
- Gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or calculus, or soft or hard tissue tumor of the oral cavity
- Less than 26 teeth in the mouth
- Orthodontic appliances or removable partial dentures that will compromise the ability of the potential subject to participate in the study
- Periodontitis as indicated periodontal pockets greater than 5 millimeters on more than one site
- Inability to comply with assigned treatment regimen
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CPC + Xylitol chewing gum, then Xylitol only chewing gum
Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum and then Xylitol only chewing gum All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for the first 21 days, then there will be a washout period of 21 days, and finally Xylitol only chewing gum will be used for the last 21 days.
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All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
|
Experimental: Xylitol only chewing gum, then CPC + Xylitol chewing gum
Xylitol only chewing gum and then Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
Xylitol only chewing gum will be used for the first 21 days, then there will be a washout period of 21 days, and finally Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for the last 21 days.
|
All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index
Time Frame: day 1
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Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index, where a score of 0 to 5 will be assigned to each facial and lingual non-restored surface of all teeth that are present with the exception of third molars at baseline and week 3 of the study, as follows. For each participant, an average of the scores for all teeth is calculated. 0 No plaque
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day 1
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Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index
Time Frame: day 22
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Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index, where a score of 0 to 5 will be assigned to each facial and lingual non-restored surface of all teeth that are present with the exception of third molars at baseline and week 3 of the study, as follows. For each participant, an average of the scores for all teeth is calculated. 0 No plaque
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day 22
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Degree of Gingivitis as Assessed by the Gingival Index (GI)
Time Frame: day 1
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Gingivitis will be assessed using the Gingival Index (GI), where a score of 0 to 3 will be assigned to six teeth, representing six segments of jaws, at baseline and week 3 of the study according to the following criteria. For each participant, an average of the scores for all 6 teeth is calculated. 0 Absence of inflammation.
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day 1
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Degree of Gingivitis as Assessed by the Gingival Index (GI)
Time Frame: day 22
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Gingivitis will be assessed using the Gingival Index (GI), where a score of 0 to 3 will be assigned to six teeth, representing six segments of jaws, at baseline and week 3 of the study according to the following criteria. For each participant, an average of the scores for all 6 teeth is calculated. 0 Absence of inflammation.
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day 22
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Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index
Time Frame: day 1
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Bleeding on probing (BOP) as described in Ainamo & Bay 1975 will be assessed, where each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth will be light probed and scored from 0 to 2 as follows. For each participant, an average of the scores for the 4 gingival areas is calculated. 0 Absence of bleeding after 30 seconds
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day 1
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Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index
Time Frame: day 22
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Bleeding on probing (BOP) as described in Ainamo & Bay 1975 will be assessed, where each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth will be light probed and scored from 0 to 2 as follows. For each participant, an average of the scores for all teeth is calculated, an average of the scores for the 4 gingival areas is calculated. 0 Absence of bleeding after 30 seconds
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day 22
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Discoloration of Teeth as Assessed by the Vita Scale
Time Frame: day 1
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Objective observation of Discoloration of teeth will be recorded using a Vita scale.
The color of the participant's teeth is matched to the colors on the scale.
The colors in the scale are A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4--the letter portion of the scale indicates a tooth color of reddish-brownish (A), reddish-yellowish (B), greyish (C), or reddish-grey (D), and the number portion of the scale indicates degree of discoloration, with 1 indicating least discoloration and 4 indicating the most discoloration.
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day 1
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Discoloration of Teeth as Assessed by the Vita Scale
Time Frame: day 22
|
Objective observation of Discoloration of teeth will be recorded using a Vita scale.
The color of the participant's teeth is matched to the colors on the scale.
The colors in the scale are A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4--the letter portion of the scale indicates a tooth color of reddish-brownish (A), reddish-yellowish (B), greyish (C), or reddish-grey (D), and the number portion of the scale indicates degree of discoloration, with 1 indicating least discoloration and 4 indicating the most discoloration.
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day 22
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Flavia Lakschevitz, DDS, PhD, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-DB-17-0313
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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