Status:
COMPLETED
A Study is to Evaluate a Regimen on Gingivitis Using Traditional and Novel Assessment Methods
Lead Sponsor:
Procter and Gamble
Conditions:
Gingivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Subjects who have shown evidence of gingivitis and plaque will be enrolled in this study. Each subject will be randomly assigned to one of two treatment products. The regimen group will be asked to br...
Eligibility Criteria
Inclusion
- 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 refrain from any form of non-specified oral hygiene during the treatment periods, including but not limited to the use of products such as floss or whitening products;
- Have a Baseline MGI score of at least 1.75 but not greater than 2.3;
- Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index);
- Agree to return for all scheduled visits and follow study procedures;
- 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
- Have had a dental prophylaxis within 2 weeks of Baseline visit;
- 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, severe gingivitis, or advanced periodontitis requiring prompt treatment; or,
- Need an antibiotic prophylaxis prior to dental visits,
- 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,
- Are pregnant (Self-reported) or lactating.
Key Trial Info
Start Date :
September 21 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2011
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT07211061
Start Date
September 21 2011
End Date
November 10 2011
Last Update
October 7 2025
Active Locations (1)
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1
Bio-Sci Research (Out of Business)
Las Vegas, Nevada, United States, 89121