Evaluate Dental Plaque Benefit of a Preventive Treatment Gel

A Clinical Study to Evaluate Anti-Plaque Benefit of a Gel in a Modified- 4 Day Plaque Model

The objective of the study is to evaluate anti-plaque efficacy of a preventive treatment gel in a modified 4-day plaque model.

Study Overview

• Status: Completed
• Conditions: Dental Plaque
• Intervention / Treatment: Drug: Preventive Gel; Drug: Marketed Control

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Mason, Ohio, United States, 45040
      • Oral Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
• Be 18 years of age or older;
• Agree not to participate in any other oral/dental product studies during the study;
• Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
• Agree to refrain from the use of any non-study oral hygiene products (subjects who are regular flossers will be allowed to floss during acclimation and wash-out periods);
• Agree to use an oral hygiene product that contains stannous fluoride;
• Agree to refrain from any form of non-specified oral hygiene during the treatment period, including the use of products such as floss, toothpicks for plaque removal, and chewing gum;
• Agree to refrain from any oral hygiene, eating and drinking after 11:00 PM the evening before plaque measurements on Day 0 and Day 4 of the treatment periods;
• Agree to return for all scheduled visits and follow study procedures;
• Possess a minimum of 20 natural teeth with scorable facial and lingual surfaces, of which at least 4 are molars; and,
• Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.

Exclusion Criteria:• Have a medical condition requiring pre-medication prior to dental procedures;

• Have taken antibiotics within 2 weeks of the acclimation period or anticipate taking antibiotics at any time during the study;
• Have a history of allergies or hypersensitivity to dyes or dentifrices that contain stannous fluoride;
• Have removable or orthodontic appliances which interfere with obtaining 20 gradable teeth;
• Have previously demonstrated an inability to comply with study visit requirements;
• Have rampant caries, open or untreated caries, severe gingivitis or advanced periodontitis requiring prompt treatment; or,
• Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preventive Gel; 0.4% stannous fluoride	Drug: Preventive Gel; 0.4% Stannous Fluoride
Active Comparator: Marketed Control; 0.243 % Sodium Fluoride	Drug: Marketed Control; 0.243% Sodium Fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Turesky Modified Quigley-Hein Index at Day 4	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.	Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Turesky Modified Quigley-Hein Index at 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.	Baseline
Digital Plaque Imaging	Total percent dental plaque area	Day 4
Overall Baseline Mean Digital Plaque Imaging	Total percent dental plaque area	Baseline

Collaborators and Investigators

• Sponsor: Procter and Gamble

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2018
• Primary Completion (Actual): June 22, 2018
• Study Completion (Actual): June 22, 2018

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: 2018009

Drug and device information, study documents

• 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