Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-01-04 @ 4:17 PM
Study NCT ID:
NCT03160703
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
2017-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Proof of Principal Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate and compare the stain build up of two stannous fluoride (SnF2) / sodium tripolyphosphate (STP) dentifrices of differing abrasivity levels, with a marketed standard fluoride dentifrice and a marketed SnF2 dentifrice.
Detailed Description:
This proof of principal (PoP) single centre, randomised, examiner blind, four-treatment arm, parallel design study will be used to evaluate and compare the stain buildup of two 0.454% SnF2/ 5% STP dentifrices of differing abrasivity levels, with a marketed standard fluoride dentifrice and a marketed SnF2 dentifrice. Stain will be assessed following a full professional dental prophylaxis, at intervals over a 4 week treatment period, using an established clinical measure of extrinsic dental stain - the MacPherson modification of the Lobene stain index (MLSI). Participants will be stratified by pre-prophylaxis MLSI score (total MLSI Area x Intensity (A×I) for the facial surfaces of the 12 anterior teeth) and smoking status. The study will be conducted in healthy participants with a propensity for extrinsic dental stain (in the opinion of the examiner) on the facial surfaces of the anterior teeth.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: