Analysis of Stannous Fluoride in GCF and Subgingival Plaque

NCT03296657 | Completed

• 1 other identifier: CSD2017123
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Subgingival Plaque; GCF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Amount of tin in GCF and Subgingival Plaque

  change from visit (change from 24 hours to baseline, change Week 2 to baseline)

Study Arms (1)

stannous fluoride toothpaste

EXPERIMENTAL

0.454% stannous fluoride will be used twice a day, brushing for at least 1 minute for 2 weeks

Drug: stannous fluoride

Interventions

stannous fluoride DRUG

subjects will brush with paste twice daily for 2 weeks

stannous fluoride toothpaste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Salus Research

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Interventions

Tin Fluorides

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Tin Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Jeff Milleman

  Salus Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: subject will brush twice a day for 2 weeks with stannous fluoride paste for at least 1 minute

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 28, 2017
• Study Start: August 23, 2017
• Primary Completion: September 22, 2017
• Study Completion: September 22, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

US (1)