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

Not Applicable

Completed

Interventions: Other: Sodium monofluorophosphate (SMFP)
Other: Stannous fluoride (SnF2)

Brief Summary: 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.

Detailed Description: This single centre, randomized, controlled, examiner-blind, 2 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the two selected teeth), with a treatment period of 8 weeks will investigate the clinical effectiveness of an experimental stannous fluoride dentifrice in the reduction of DH. DH will be assessed at Baseline, and after 4 and 8 weeks treatment to monitor clinical efficacy and safety.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Negative Control Dentifrice: Sodium monofluorophosphate (SMFP)	Sodium monofluorophosphate (SMFP)	Participants were instructed to apply a strip of dentifrice containing 1400ppm fluoride as sodium monofluorophosphate (SMFP) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.
Test Dentifrice: Stannous fluoride (SnF2)	Stannous fluoride (SnF2)	Participants were instructed to apply a strip of dentifrice containing 0.454% stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF) (1450 parts per million \[ppm\] fluoride in total) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Schiff Sensitivity Score at Week 8	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Schiff Sensitivity Score at Week 4	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.
Change From Baseline in Tactile Threshold at Week 4 and 8	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; at all subsequent visits, it was 80g.