A Pilot Study to Evaluate a Method for Plaque When Comparing Stannous Fluoride Toothpaste to a Regular Dentifrice
Status: | Completed |
---|---|
Conditions: | Dental |
Therapuetic Areas: | Dental / Maxillofacial Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/8/2017 |
Start Date: | June 2015 |
End Date: | August 2015 |
A Pilot Study to Evaluate the Sensitivity of a Novel Molecular Method for Plaque Toxicity When Comparing Two-step Toothpaste to a Regular Dentifrice
This study will evaluate the sensitivity of an assay and its ability to split a marketed
stannous fluoride toothpaste versus a negative control.
stannous fluoride toothpaste versus a negative control.
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.
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