Clinical trial NCT03296657: Analysis of Stannous Fluoride in GCF and Subgingival Plaque
Official title: A Pilot Study to Evaluate Stannous Fluoride in GCF and Subgingival Plaque
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subgingival Plaque
GCF
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2017-09-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: subject will brush twice a day for 2 weeks with stannous fluoride paste for at least 1 minute
Primary purpose: BASIC_SCIENCE

Brief summary: The amount of stannous fluoride in GCF and subgingival plaque samples will be analyzed.

Detailed description: This is pilot study involving approximately 20 subjects with at least 20 dental pockets between 2- 4mm with bleeding for sampling. Subjects will have up to 10 sites identified as "sampling sites" that will have supragingival plaque, subgingival plaque, and gingival crevicular fluid (GCF) collected at Baseline, 30 minutes, 24 hours, and Week 2.

Eligibility criteria: Inclusion Criteria:

* 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 use the acclimation products and to refrain from using any other oral care products (including floss and mouth rinse) between the Acclimation and Baseline Visit;
* Agree to use the treatment products and 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, mouth rinse, 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 after 11 p.m. the night prior to each visit;
* Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit;
* Have minimum 20 sampling sites with bleeding and pocket depth ≥2mm but not deeper than 4mm.

Exclusion Criteria:

* Having a dental prophylaxis within 2 weeks of Acclimation visit;
* Having rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
* A medical condition requiring an antibiotic prophylaxis prior to dental visits;
* A history of hypersensitivity to oral care products containing stannous fluoride; or
* Have any condition or disease, as determined by the Investigator/Designee based on a review of the medical history, which could be expected to interfere with examination procedures or with the subject's safe completion of the study.

Primary outcomes:
measure: Amount of tin in GCF sample
timeFrame: mean difference from 30 minutes to baseline
Secondary outcomes:
measure: Amount of tin in GCF and Subgingival Plaque
timeFrame: change from visit (change from 24 hours to baseline, change Week 2 to baseline)
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research
state: Indiana
Study officials:
affiliation: Salus Research
name: Jeff Milleman
role: PRINCIPAL_INVESTIGATOR
References: