A Pilot Study to Evaluate a Method for Plaque When Comparing Stannous Fluoride Toothpaste to a Regular Dentifrice
Not Applicable
Completed
- Conditions
- PlaqueGingivitis
- Interventions
- Drug: stannous fluoride toothpasteDrug: 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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does stannous fluoride use to reduce plaque toxicity compared to cavity protection toothpaste?
How does stannous fluoride toothpaste compare to standard-of-care dentifrices in managing gingivitis and plaque?
Are there specific biomarkers that indicate better response to stannous fluoride over conventional toothpaste in plaque reduction?
What are the potential adverse effects of stannous fluoride toothpaste and how are they managed in clinical settings?
What are the competitive advantages of stannous fluoride-based dentifrices over other anti-plaque agents in the market?
Trial Locations
- Locations (1)
Salus Research
🇺🇸Fort Wayne, Indiana, United States
Salus Research🇺🇸Fort Wayne, Indiana, United States