MedDataX Logo

Analysis of Stannous Fluoride in GCF and Subgingival Plaque

NCT ID: NCT03296657

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-23

Study Completion Date

2017-09-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Subgingival Plaque GCF

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

subject will brush twice a day for 2 weeks with stannous fluoride paste for at least 1 minute
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

stannous fluoride toothpaste

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

Group Type EXPERIMENTAL

stannous fluoride

Intervention Type DRUG

subjects will brush with paste twice daily for 2 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

stannous fluoride

subjects will brush with paste twice daily for 2 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Procter and Gamble

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeff Milleman

Role: PRINCIPAL_INVESTIGATOR

Salus Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Salus Research

Fort Wayne, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSD2017123

Identifier Type: -

Identifier Source: org_study_id