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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03219840

Enrollment

Registered

2017-07-18

Start date

2017-10-18

Completion date

2018-09-08

Last updated

2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis, Periodontal Diseases, Plaque, Dental

Keywords

Cetylpyridium Chloride (CPC), Chewing Gum

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).

Interventions

DRUGCetylpyridinium 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.

DRUGXylitol only chewing gum

All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

A Randomized, Double-blind, Crossover, Placebo-controlled Clinical Trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index	day 1	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 1. Separate flecks of plaque at the cervical margin of the tooth 2. A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth 3. A band of plaque wider than one mm but covering less than one-third of the crown of the tooth 4. Plaque covering at least one-third but less than two-thirds of the crown of the tooth 5. Plaque covering two-thirds or more of the crown of the tooth
Degree of Gingivitis as Assessed by the Gingival Index (GI)	day 1	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. 1. Mild inflammation - slight change in color and little change in texture. 2. Moderate inflammation - moderate glazing, redness, edema, and hypertrophy. Bleeding on pressure. 3. Severe inflammation - marked redness and hypertrophy. Tendency to spontaneous bleeding. Ulceration.
Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index	day 1	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 1. Bleeding after 30 seconds 2. Immediate bleeding

Secondary

Measure	Time frame	Description
Discoloration of Teeth as Assessed by the Vita Scale	day 1	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.

Countries

United States

Participant flow

Pre-assignment details

1 participant was enrolled but then was lost to follow up before randomization.

Participants by arm

Arm	Count
All Participants Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used during one period of 21 days and Xylitol only chewing gum will be used during another period of 21 days, with the two periods divided by a washout period of 21 days. All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.	69
Total	69

Baseline characteristics

Characteristic	All Participants	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	69 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	69 Participants	—
Sex: Female, Male Female	40 Participants	—
Sex: Female, Male Male	29 Participants	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 65	0 / 65
other Total, other adverse events	0 / 65	0 / 65
serious Total, serious adverse events	0 / 65	0 / 65

Outcome results

Primary

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 1. Bleeding after 30 seconds 2. Immediate bleeding

Time frame: day 1