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NCT02226562 · ClinicalTrials.gov registry record · Phase 2

Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
191
Enrollment target

NCT02226562: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT02226562 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 191 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02226562, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
191 participants
Enrollment target

Study Summary

The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth) study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.

Primary Outcome

The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reducti

Interventions

  • DRUG Potassium nitrate and sodium fluoride
  • DRUG Standard fluoride dentifrice

Trial Details

FieldValue
Enrollment Target 191 participants
Start Date 2014-09-02
Est. Completion 2014-12-05
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT02226562 record still lists

NCT02226562 is an interventional study that assigns participants to a tested intervention. The registered 191 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher).

The record links to 0 conditions, and to 2 interventions - of which Potassium nitrate and sodium fluoride is the first listed.

NCT02226562 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02226562 about?

NCT02226562 is a clinical study titled "Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity". The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard fluoride dentifrice alone. This...

What is the current status of trial NCT02226562?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 191 participants. The study started on 2014-09-02. Estimated completion is 2014-12-05.

What interventions are being tested in trial NCT02226562?

The interventions under investigation include: Potassium nitrate and sodium fluoride (DRUG), Standard fluoride dentifrice (DRUG).

Who is sponsoring clinical trial NCT02226562?

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 NCT02226562's enrollment target sits among peer trials

191 353rd of 2000 higher than 1,648 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 NCT02226562, the US trial registry maintained by the National Library of Medicine. NCT02226562 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.