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NCT03267511 · ClinicalTrials.gov registry record · Phase 2

A Study to Investigate the Stain and Plaque Removal Capability of Two Experimental Potassium Nitrate Dentifrices

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
123
Enrollment target

NCT03267511: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT03267511 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 123 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03267511, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
123 participants
Enrollment target

Study 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.

Primary Outcome

An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI to evaluate ranking order in extrinsic dental stain removal or reduction of test product 1, test product 2, reference product 1, reference product 2; after usage for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The are

Interventions

  • DRUG 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica
  • DRUG 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP
  • DRUG 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica
  • DRUG 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP

Trial Details

FieldValue
Enrollment Target 123 participants
Start Date 2017-09-25
Est. Completion 2017-12-02
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT03267511 record still lists

NCT03267511 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 4 interventions - of which 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica is the first listed.

NCT03267511 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03267511 about?

NCT03267511 is a clinical study titled "A Study to Investigate the Stain and Plaque Removal Capability of Two Experimental Potassium Nitrate Dentifrices". 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 cl...

What is the current status of trial NCT03267511?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2017-09-25. Estimated completion is 2017-12-02.

What interventions are being tested in trial NCT03267511?

The interventions under investigation include: 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica (DRUG), 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP (DRUG), 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica (DRUG), 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP (DRUG).

Who is sponsoring clinical trial NCT03267511?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03267511's enrollment target sits among peer trials

123 564th of 2000 higher than 1,436 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03267511, the US trial registry maintained by the National Library of Medicine. NCT03267511 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.