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Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis

Primary Purpose

Gingivitis, Plaque, Dental, Periodontal Diseases

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum
Xylitol only chewing gum
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis focused on measuring Cetylpyridium Chloride (CPC), Chewing Gum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CPC + Xylitol chewing gum, then Xylitol only chewing gum

Xylitol only chewing gum, then CPC + Xylitol chewing gum

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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.
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.
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
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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 13, 2017
Last Updated
January 14, 2021
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
CONFADENT Oral Technology, Kiss Industries LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03219840
Brief Title
Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 18, 2017 (Actual)
Primary Completion Date
September 8, 2018 (Actual)
Study Completion Date
September 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
CONFADENT Oral Technology, Kiss Industries LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Plaque, Dental, Periodontal Diseases
Keywords
Cetylpyridium Chloride (CPC), Chewing Gum

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
A Randomized, Double-blind, Crossover, Placebo-controlled Clinical Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPC + Xylitol chewing gum, then Xylitol only chewing gum
Arm Type
Experimental
Arm Description
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.
Arm Title
Xylitol only chewing gum, then CPC + Xylitol chewing gum
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum
Intervention Description
All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
Intervention Type
Drug
Intervention Name(s)
Xylitol only chewing gum
Intervention Description
All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
Primary Outcome Measure Information:
Title
Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index
Description
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
Time Frame
day 1
Title
Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index
Description
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
Time Frame
day 22
Title
Degree of Gingivitis as Assessed by the Gingival Index (GI)
Description
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.
Time Frame
day 1
Title
Degree of Gingivitis as Assessed by the Gingival Index (GI)
Description
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.
Time Frame
day 22
Title
Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index
Description
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
Time Frame
day 1
Title
Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index
Description
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
Time Frame
day 22
Secondary Outcome Measure Information:
Title
Discoloration of Teeth as Assessed by the Vita Scale
Description
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.
Time Frame
day 1
Title
Discoloration of Teeth as Assessed by the Vita Scale
Description
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.
Time Frame
day 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavia Lakschevitz, DDS, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis

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