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

Not Applicable

Completed

• Conditions: Plaque; Gingivitis
• Interventions: Drug: stannous fluoride toothpaste; Drug: cavity protection toothpaste

• Registration Number: NCT02543060
• Lead Sponsor: Procter and Gamble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stannous fluoride toothpaste	stannous fluoride toothpaste	brush twice a day for 8 weeks
cavity protection toothpaste	cavity protection toothpaste	brush twice a day for 8 weeks

Primary Outcome Measures

Name	Time	Method
plaque scores	week 8

Secondary Outcome Measures

Name	Time	Method
gingivitis score	8 weeks

Trial Locations

Locations (1)

Salus Research; 🇺🇸 Fort Wayne, Indiana, United States