Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis

Study Overview
=================
Brief Summary
-----------------
This placebo-controlled, double-blinded, randomized crossover study evaluates the plaque and gingivitis reducing capacity of Cetylpyridium Chloride (CPC) chewing gum, with mechanical oral hygiene. The study will enroll 73 students, faculty, and staff from the UTHealth School of Dentistry. Half of the eligible participants will be randomly assigned to get the CPC gum in the first treatment period (21 days), a wash-out period of 21 days, and then a placebo gum in the second treatment period (21 days). The other half will be assigned to follow the same schedule but with the treatment reversed. A statistician will perform the randomization. Primary outcomes are assessed by validated tools, such as the Plaque Index (PI), Gingival Index (GI), and percent of bleeding sites on probe (BOP).

Official Title
-----------------
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

Conditions
-----------------
Gingivitis, Plaque, Dental, Periodontal Diseases

Intervention / Treatment
-----------------
* Drug: Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum
* Drug: Xylitol only chewing gum


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A Randomized, Double-blind, Crossover, Placebo-controlled Clinical Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPC + Xylitol chewing gum, then Xylitol only chewing gum<br>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. | Drug: Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum<br>* All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.<br>Drug: Xylitol only chewing gum<br>* All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.<br>|
| Experimental: Xylitol only chewing gum, then CPC + Xylitol chewing gum<br>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. | Drug: Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum<br>* All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.<br>Drug: Xylitol only chewing gum<br>* All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.<br>|

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 | 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 Separate flecks of plaque at the cervical margin of the tooth A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth A band of plaque wider than one mm but covering less than one-third of the crown of the tooth Plaque covering at least one-third but less than two-thirds of the crown of the tooth Plaque covering two-thirds or more of the crown of the tooth | day 1 | 
| Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index | 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 Separate flecks of plaque at the cervical margin of the tooth A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth A band of plaque wider than one mm but covering less than one-third of the crown of the tooth Plaque covering at least one-third but less than two-thirds of the crown of the tooth Plaque covering two-thirds or more of the crown of the tooth | day 22 | 
| Degree of Gingivitis as Assessed by the Gingival Index (GI) | 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. Mild inflammation - slight change in color and little change in texture. Moderate inflammation - moderate glazing, redness, edema, and hypertrophy. Bleeding on pressure. Severe inflammation - marked redness and hypertrophy. Tendency to spontaneous bleeding. Ulceration. | day 1 | 
| Degree of Gingivitis as Assessed by the Gingival Index (GI) | 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. Mild inflammation - slight change in color and little change in texture. Moderate inflammation - moderate glazing, redness, edema, and hypertrophy. Bleeding on pressure. Severe inflammation - marked redness and hypertrophy. Tendency to spontaneous bleeding. Ulceration. | day 22 | 
| Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index | 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 Bleeding after 30 seconds Immediate bleeding | day 1 | 
| Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index | 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 Bleeding after 30 seconds Immediate bleeding | day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discoloration of Teeth as Assessed by the Vita Scale | 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. | day 1 | 
| Discoloration of Teeth as Assessed by the Vita Scale | 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. | day 22 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cetylpyridium Chloride (CPC), Chewing Gum