A Pilot Study to Evaluate a Molecular Method for Plaque

Gingivitis Clinical Trial

Official title:

A Pilot Study to Evaluate the Sensitivity of a Novel Molecular Method for Plaque Toxicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574221
• Other study ID #: 2015049
• Status: Completed
• Phase: N/A
• First received: October 9, 2015
• Last updated: October 4, 2017
• Start date: August 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2017
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the sensitivity of the molecular method and its ability to split a stannous fluoride toothpaste versus a negative control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 stannous fluoride;

• 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.

Related Conditions & MeSH terms

• Gingivitis
• Plaque

Intervention

Drug:
• stannous fluoride toothpaste
0.454% stannous fluoride toothpaste
• cavity protection toothpaste
0.243% sodium fluoride toothpaste

Locations

Country	Name	City	State
United States	Salus Research	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plaque scores		baseline
Primary	plaque scores		week 8
Secondary	gingivitis score		baseline
Secondary	gingivitis score		week 8