A Pilot Study to Evaluate a Molecular Method for Plaque



Status:Completed
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - Any
Updated:10/8/2017
Start Date:August 2015
End Date:October 2015

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

This study is to evaluate the sensitivity of the molecular method and its ability to split a
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 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.
We found this trial at
1
site
Fort Wayne, Indiana 46825
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mi
from
Fort Wayne, IN
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