NCT02923895

To Investigate the Efficacy of an Occluding Dentifrice in Dentinal Hypersensitivity (DH)

Completed Phase 4 Results posted Last updated 29 October 2018

What this trial tests

Phase 4 trial testing Stannous fluoride in Dentin Sensitivity in 197 participants. Completed in 16 December 2016.

Timeline

11 October 2016

Primary endpoint
16 December 2016

16 December 2016

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	197
Start date	11 October 2016
Primary completion	16 December 2016
Estimated completion	16 December 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 and Day 3

The examiner assessed the participant's response to an evaporative air stimulus for each of the two test tooth using the Schiff Sensitivity Scale which was scored as follows: 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 requests discontinuation or moves from stimulus, 3 Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. The Schiff sensitivity score was calculated as the average of individual test

At Baseline (Day 0, Pre-treatment)

Group	Value	95% CI
Test Dentifrice	2.44	± 0.450
Control Dentifrice	2.49	± 0.475

At Day 3

Group	Value	95% CI
Test Dentifrice	1.01	± 0.956
Control Dentifrice	2.37	± 0.571

Change from Baseline

Group	Value	95% CI
Test Dentifrice	-1.44	± 0.811
Control Dentifrice	-0.13	± 0.431

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

Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 gram\[g\] to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactil

At Baseline

Group	Value	95% CI
Test Dentifrice	13.40	± 4.242
Control Dentifrice	13.58	± 4.416

At Day 3

Group	Value	95% CI
Test Dentifrice	39.28	± 20.979
Control Dentifrice	14.89	± 6.357

Change from Baseline

Group	Value	95% CI
Test Dentifrice	25.88	± 19.804
Control Dentifrice	1.32	± 6.111

Change From Baseline in Schiff Sensitivity Score After a Single Use Secondary · Baseline to 60 seconds post first treatment

The examiner assessed the participant's response to an evaporative air stimulus for each of the two test tooth using the Schiff Sensitivity Scale which was scored as follows: 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 requests discontinuation or moves from stimulus, 3 Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. The Schiff sensitivity score was calculated as the average of individual test

At Baseline (Day 0, Pre-treatment)

Group	Value	95% CI
Test Dentifrice	2.44	± 0.450
Control Dentifrice	2.49	± 0.475

Day 0 (Post-treatment)

Group	Value	95% CI
Test Dentifrice	1.76	± 0.781
Control Dentifrice	2.40	± 0.534

Change from Baseline

Group	Value	95% CI
Test Dentifrice	-0.68	± 0.704
Control Dentifrice	-0.09	± 0.401

Change From Baseline in Tactile Threshold After a Single Use Secondary · Baseline to 60 seconds post first treatment

Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile thresh

At Baseline (Day 0, Pre-treatment)

Group	Value	95% CI
Test Dentifrice	13.40	± 4.242
Control Dentifrice	13.58	± 4.416

Day 0, Post-treatment

Group	Value	95% CI
Test Dentifrice	22.47	± 11.839
Control Dentifrice	14.63	± 6.069

Change from Baseline

Group	Value	95% CI
Test Dentifrice	9.07	± 11.418
Control Dentifrice	1.05	± 5.644

Adverse events — posted to ClinicalTrials.gov

Time frame: Approximately 64 days (from Screening Visit to till 5 days following last administration of study product on Visit 3). Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Test Dentifrice

Serious: 0/97 (0%)

Deaths: 0/97

Control Dentifrice

Serious: 0/95 (0%)

Deaths: 0/95

Other adverse events (1 terms — click to expand)

Reaction	System	Test Dentifrice	Control Dentifrice
Headache	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT02923895 adverse events section.

Sponsor's own description

This single centre 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