CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 123 enrolled
Drug / intervention
5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03267511
NCT03267511Phase 2Completed
CompareCT.gov

A Randomized, Examiner-blind, Proof of Principal Study to Investigate the Stain and Plaque Removal Capability of Two Experimental 5% Potassium Nitrate Dentifrices in Healthy Subjects With the Propensity for Extrinsic Dental Stain

GlaxoSmithKline·interventional·Posted Aug 30, 2017·Updated Jan 8, 2019

In Brief

A Phase 2 clinical trial evaluating 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica, 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP, and 2 other interventions for Oral Hygiene. Completed, enrolled 123 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether spherical silica can achieve similar or greater extrinsic dental stain and plaque removal, in comparison to dentifrices containing higher concentrations of standard abrasive silica, and how the addition of 5% sodium tripolyphosphate (STP) enhances cleaning capability.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Hygiene
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 30, 2017
Enrollment StartSep 25, 2017
Primary CompletionDec 2, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.8 years ago

Interventions

5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silicadrug

Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica and brush twice daily (morning and evening) for one timed minute (in their usual manner).

5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STPdrug

Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner).

5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silicadrug

Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica and brush twice daily (morning and evening) for one timed minute (in their usual manner).

5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STPdrug

Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner).