A Pilot Study to Evaluate a Method for Plaque When Comparing Stannous Fluoride Toothpaste to a Regular Dentifrice

NCT ID: NCT02543060

Last Updated: 2017-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-08-31

Brief Summary

This study will evaluate the sensitivity of an assay and its ability to split a marketed stannous fluoride toothpaste versus a negative control.

Conditions

Plaque; Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

stannous fluoride toothpaste

brush twice a day for 8 weeks

Group Type: EXPERIMENTAL

stannous fluoride toothpaste

Intervention Type: DRUG

0.454% stannous fluoride toothpaste

cavity protection toothpaste

brush twice a day for 8 weeks

Group Type: SHAM_COMPARATOR

cavity protection toothpaste

Intervention Type: DRUG

0.243% sodium fluoride toothpaste

Interventions

stannous fluoride toothpaste

0.454% stannous fluoride toothpaste

Intervention Type: DRUG

cavity protection toothpaste

0.243% sodium fluoride toothpaste

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

In order to be included in the study, each subject must:

• Provide written informed consent to participate in the study;
• Be 18 years of age or older;
• Agree not to participate in any other oral/dental product studies during the course of this study;
• Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
• Agree to maintain their current oral hygiene routine between the Screening and Baseline Visit and not to add/change their oral care products during this time;
• Agree to refrain from any form of non-specified oral hygiene during the treatment periods (after the Baseline Visit), including but not limited to the use of products such as floss or whitening products;
• Agree to return for all scheduled visits and follow study procedures;
• Must have at least 16 natural teeth;
• 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;
• Agree to refrain from all oral hygiene for at least 12 hours prior to each visit;
• Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit;
• Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index);
• Have minimum 3 sampling sites with bleeding and pocket depth ≥3mm but not deeper than 4mm;
• Have minimum 3 sampling sites without bleeding and with pocket depth ≤2mm.

Exclusion Criteria

Subjects are excluded from study participation where there is evidence of:

• Have had a dental prophylaxis within 2 weeks of plaque sampling visits;
• Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
• Have rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
• Need an antibiotic prophylaxis prior to dental visits;
• A history of hypersensitivity to oral care products containing hydrogen peroxide;
• A history of hypersensitivity to dyes (from products containing food dyes);
• 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; or
• Are pregnant (Self-reported) or lactating.

• 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

Salus Research

Fort Wayne, Indiana, United States

Countries

United States

Other Identifiers

2015062

Identifier Type: -

Identifier Source: org_study_id