A Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices

Sponsor

Procter and Gamble (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT06140784

Collaborator

(none)

120

Enrollment

Location

Arms

3.3

Anticipated Duration (Months)

36.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the effect four different dentifrices have on gingivitis after 12 weeks of product use. The secondary objectives are to assess the effect four dentifrices, have on plaque and oral microbiome composition.

Condition or Disease	Intervention/Treatment	Phase
Gingivitis	Drug: 0.76% Sodium Monofluorophosphate Dentifrice Drug: 0.454% Stannous Fluoride Dentifrice Drug: 0.454% Stannous Fluoride Dentifrice Drug: 0.454% Stannous Fluoride Dentifrice	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Three-Month Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices

Actual Study Start Date :

Sep 2, 2023

Anticipated Primary Completion Date :

Dec 10, 2023

Anticipated Study Completion Date :

Dec 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: 0.76% Sodium Monofluorophosphate Dentifrice	Drug: 0.76% Sodium Monofluorophosphate Dentifrice Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
Active Comparator: Marketed 0.454% Stannous Fluoride plus Arginine Dentifrice	Drug: 0.454% Stannous Fluoride Dentifrice Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
Active Comparator: Marketed 0.454% Stannous Fluoride Dentifrice	Drug: 0.454% Stannous Fluoride Dentifrice Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
Active Comparator: 0.454% Stannous Fluoride Dentifrice	Drug: 0.454% Stannous Fluoride Dentifrice Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

Outcome Measures

Primary Outcome Measures

Löe-Silness Gingivitis Evaluation [3 Months]
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

Secondary Outcome Measures

Löe-Silness Gingivitis Evaluation [Baseline]
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Löe-Silness Gingivitis Evaluation [1 Month]
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Mean Turesky Modified Quigley-Hein Index [Baseline]
The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.
Mean Turesky Modified Quigley-Hein Index [1 Month]
The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.
Mean Turesky Modified Quigley-Hein Index [3 Months]
The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Be at least 18 years of age;
Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
Have at least 16 gradable teeth;
Have mild to moderate gingivitis with at least 20 bleeding sites;
Agree to return for scheduled visits and follow the study procedures;
Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study;
Agree to refrain from any oral hygiene the morning of your visit
Agree to refrain from eating, drinking (except water), using tobacco, floss, use toothpicks, breath mints, or chew gum after performing your evening brushing.

Exclusion Criteria:

Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
Having had a dental prophylaxis within 2 weeks of plaque sampling visits;
Removable oral appliances;
Fixed facial or lingual orthodontic appliances;
Self-reported pregnancy or lactation;
Any diseases or condition that might interfere with the safe participation in the study; and
Inability to undergo study procedures.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UHRG	Whittier	California	United States	90602

Sponsors and Collaborators

Procter and Gamble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Procter and Gamble

ClinicalTrials.gov Identifier:

NCT06140784

Other Study ID Numbers:

2023043

First Posted:

Nov 20, 2023

Last Update Posted:

Nov 20, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 20, 2023