Gingivitis Clinical Trial
Official title:
A Pilot Study to Evaluate the Sensitivity of a Novel Molecular Method for Plaque Toxicity When Comparing Two-step Toothpaste to a Regular Dentifrice
Verified date | October 2017 |
Source | Procter and Gamble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the sensitivity of an assay and its ability to split a marketed stannous fluoride toothpaste versus a negative control.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 2015 |
Est. primary completion date | August 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 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. |
Country | Name | City | State |
---|---|---|---|
United States | Salus Research | Fort Wayne | Indiana |
Lead Sponsor | Collaborator |
---|---|
Procter and Gamble |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | plaque scores | baseline | ||
Primary | plaque scores | week 8 | ||
Secondary | gingivitis score | baseline | ||
Secondary | gingivitis score | 8 weeks |
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