Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum

Xylitol only chewing gum

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

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

NCT ID

NCT03219840

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

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

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

Gingivitis, Plaque, Dental, Periodontal Diseases

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial