NCT02861664

Assessment of the Efficacy of an Experimental Occlusion Technology Dentifrice in Dentinal Hypersensitivity

Completed NA Results posted Last updated 10 August 2018

What this trial tests

NA trial testing Stannous fluoride (SnF2) in Dentin Sensitivity in 135 participants. Completed in 24 December 2016.

Timeline

21 September 2016

Primary endpoint
1 December 2016

24 December 2016

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	135
Start date	21 September 2016
Primary completion	1 December 2016
Estimated completion	24 December 2016
Sites	1 location across China

Drugs / interventions tested

• Stannous fluoride (SnF2)
• Sodium monofluorophosphate (SMFP)

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 at Week 8 Primary · At Baseline and Week 8

The examiner assessed the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale 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. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.

Group	Value	95% CI
Test Dentifrice: Stannous Fluoride (SnF2)	-0.94	± 0.526
Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)	-0.33	± 0.699

Change From Baseline in Schiff Sensitivity Score at Week 4 Secondary · At Baseline and Week 4

The examiner assessed the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale 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. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.

Group	Value	95% CI
Test Dentifrice: Stannous Fluoride (SnF2)	-0.63	± 0.570
Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)	-0.10	± 0.512

Change From Baseline in Tactile Threshold at Week 4 and 8 Secondary · At Baseline, Week 4 and Week 8

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 has 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 gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g;

Change from baseline at Week 4

Group	Value	95% CI
Test Dentifrice: Stannous Fluoride (SnF2)	4.8	± 8.57
Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)	4.9	± 12.31

Change from baseline at Week 8

Group	Value	95% CI
Test Dentifrice: Stannous Fluoride (SnF2)	10.4	± 14.87
Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)	8.4	± 16.73

Sponsor's own description

This study will evaluate the effectiveness of an experimental dentifrice containing stannous fluoride, an established dentine tubule occlusion technology, at reducing dentine hypersensitivity (DH) compared to a negative control dentifrice. The test and control dentifrices will be administered for a total of 8 weeks, with assessments (via evaporative air and tactile stimuli) at baseline, and after 4 and 8 weeks twice-daily use.

Publications & conference data

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

1. Efficacy of an Experimental Occlusion Technology Toothpaste in the Relief of Dentinal Hypersensitivity: An 8-week Randomised Controlled Trial.
   Creeth JE, Burnett GR. · · 2021 · PMID 33723979 · DOI 10.3290/j.ohpd.b1075109