NCT02731833

Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

Completed Phase 4 Results posted Last updated 17 May 2017

What this trial tests

Phase 4 trial testing stannous fluoride in Dentin Sensitivity in 229 participants. Completed in 20 May 2016.

Timeline

1 April 2016

Primary endpoint
1 May 2016

20 May 2016

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	229
Start date	1 April 2016
Primary completion	1 May 2016
Estimated completion	20 May 2016
Sites	1 location across Canada

Drugs / interventions tested

• stannous fluoride — full drug profile →
• sodium monofluorophosphate — full drug profile →

Conditions studied

• Dentin Sensitivity — all drugs for Dentin Sensitivity →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Dentin Sensitivity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Schiff Sensitivity Score on Day 3 Primary · Baseline to Day 3

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensiti

Group	Value	95% CI
Stannous Fluoride	-0.40	± 0.485
Sodium Monofluorophosphate	0.00	± 0.257

Change From Baseline in Tactile Threshold on Day 3 Secondary · Baseline to Day 3

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.

Group	Value	95% CI
Stannous Fluoride	3.69	± 4.941
Sodium Monofluorophosphate	0.09	± 2.521

Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application Secondary · Baseline to 60 seconds post first treatment

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensiti

Group	Value	95% CI
Stannous Fluoride	-0.17	± 0.340
Sodium Monofluorophosphate	-0.02	± 0.269

Change From Baseline in Tactile Threshold Post First Treatment by Direct Application Secondary · Baseline to 60 seconds post first treatment

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.

Group	Value	95% CI
Stannous Fluoride	1.71	± 3.268
Sodium Monofluorophosphate	0.18	± 2.328

Sponsor's own description

This single centre, comparative design study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use compared with a standard fluoride dentifrice

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomised clinical studies investigating immediate and short-term efficacy of an occluding toothpaste in providing dentine hypersensitivity relief.
   Creeth J, Gallob J, Sufi F, Qaqish J, et al · · 2019 · cited 8× · PMID 31164116 · DOI 10.1186/s12903-019-0781-x