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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03219840
Other study ID # HSC-DB-17-0313
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 18, 2017
Est. completion date September 8, 2018

Study information

Verified date January 2021
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date September 8, 2018
Est. primary completion date September 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston CONFADENT Oral Technology, Kiss Industries LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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
Bleeding after 30 seconds
Immediate bleeding
day 1
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 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 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
Secondary 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
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