Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/8/2018 |
| Start Date: | October 18, 2017 |
| End Date: | November 30, 2018 |
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
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).
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).
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
We found this trial at
1
site
Houston, Texas 77030
Phone: 713-486-4287
Click here to add this to my saved trials
