Evaluate Dental Plaque Benefit of a Preventive Treatment Gel

NCT ID: NCT03546491

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-08
• Study Completion Date: 2018-06-22

Brief Summary

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

Conditions

Dental Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Preventive Gel

0.4% stannous fluoride

Group Type: EXPERIMENTAL

Preventive Gel

Intervention Type: DRUG

0.4% Stannous Fluoride

Marketed Control

0.243 % Sodium Fluoride

Group Type: ACTIVE_COMPARATOR

Marketed Control

Intervention Type: DRUG

0.243% Sodium Fluoride

Interventions

Preventive Gel

0.4% Stannous Fluoride

Intervention Type: DRUG

Marketed Control

0.243% Sodium Fluoride

Intervention Type: DRUG

Eligibility Criteria

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Oral Health Science Center

Mason, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018009

Identifier Type: -

Identifier Source: org_study_id