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NCT01691560 · ClinicalTrials.gov registry record · Phase 2

Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
140
Enrollment target

NCT01691560: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT01691560 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 140 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

NCT01691560, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
140 participants
Enrollment target

Study Summary

The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.

Primary Outcome

Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, c

Interventions

  • DRUG Sodium monofluorophosphate dentifrice
  • DRUG 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice
  • DRUG 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice
  • DRUG Sodium fluoride dentifrice

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2012-08
Est. Completion 2012-11
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT01691560 record still lists

NCT01691560 is an interventional study that assigns participants to a tested intervention. The registered 140 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 Sodium monofluorophosphate dentifrice is the first listed.

NCT01691560 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01691560 about?

NCT01691560 is a clinical study titled "Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity". The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.

What is the current status of trial NCT01691560?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2012-08. Estimated completion is 2012-11.

What interventions are being tested in trial NCT01691560?

The interventions under investigation include: Sodium monofluorophosphate dentifrice (DRUG), 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice (DRUG), 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice (DRUG), Sodium fluoride dentifrice (DRUG).

Who is sponsoring clinical trial NCT01691560?

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 NCT01691560's enrollment target sits among peer trials

140 512th of 2000 higher than 1,476 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 NCT01691560, the US trial registry maintained by the National Library of Medicine. NCT01691560 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.