Status:
COMPLETED
Analysis of Stannous Fluoride in GCF and Subgingival Plaque
Lead Sponsor:
Procter and Gamble
Conditions:
Subgingival Plaque
GCF
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03296657
Start Date
August 23 2017
End Date
September 22 2017
Last Update
November 6 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Salus Research
Fort Wayne, Indiana, United States, 46825