Clinical trial NCT02543060: A Pilot Study to Evaluate a Method for Plaque When Comparing Stannous Fluoride Toothpaste to a Regular Dentifrice
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque
Gingivitis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: plaque scores
timeFrame: baseline
measure: plaque scores
timeFrame: week 8
Secondary outcomes:
measure: gingivitis score
timeFrame: baseline
measure: gingivitis score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research
state: Indiana
Study officials:
References: