Analysis of Stannous Fluoride in GCF and Subgingival Plaque

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

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

Study Overview

• Status: Completed
• Conditions: Subgingival Plaque; GCF
• Intervention / Treatment: Drug: stannous fluoride

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Salus Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stannous fluoride toothpaste; 0.454% stannous fluoride will be used twice a day, brushing for at least 1 minute for 2 weeks	Drug: stannous fluoride; subjects will brush with paste twice daily for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Procter and Gamble
• Investigators: Principal Investigator: Jeff Milleman, Salus Research

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2017
• Primary Completion (Actual): September 22, 2017
• Study Completion (Actual): September 22, 2017

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 1, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Tin Fluorides
• Other Study ID Numbers: CSD2017123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No