Analysis of Stannous Fluoride in GCF and Subgingival Plaque

Subgingival Plaque Clinical Trial

Official title:

A Pilot Study to Evaluate Stannous Fluoride in GCF and Subgingival Plaque

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03296657
• Other study ID #: CSD2017123
• Status: Completed
• Phase: N/A
• First received: September 13, 2017
• Last updated: November 1, 2017
• Start date: August 23, 2017
• Est. completion date: September 22, 2017

Study information

• Verified date: November 2017
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 22, 2017
• Est. primary completion date: September 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• GCF
• Subgingival Plaque

Intervention

Drug:
• stannous fluoride
subjects will brush with paste twice daily for 2 weeks

Locations

Country	Name	City	State
United States	Salus Research	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of tin in GCF sample	per GCF sample amount of stannous level in ng/uL will be measured	mean difference from 30 minutes to baseline
Secondary	Amount of tin in GCF and Subgingival Plaque	stannous level in subgingival plaque will be measured as concentration in ng, per GCF sample amount of stannous level in ng/uL	change from visit (change from 24 hours to baseline, change Week 2 to baseline)