A proof of principle single-centre, randomized-controlled, examiner-blind, two treatment group study to investigate the efficacy of an experimental 15% w/w dissolvable strip in relieving dentine hypersensitivity (DH) after a single application and up to 4 hours after application compared to no treatment.
This was a single-centre, randomized-controlled, examiner-blind, two treatment group (test and no treatment), parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth) study, in healthy participants with at least two sensitive teeth that meet all the criteria at the screening and the baseline pre-treatment visit. Participants were screened for study suitability at screening visit (Visit 1). At Visit 2 (baseline; pre-treatment) 2 non-adjacent accessible teeth (incisors, canines, premolars) in different quadrants of the mouth and separated by at least 2 teeth (or equivalent edentulous space) were identified that demonstrated signs of sensitivity as measured by a qualifying tactile stimulus (Yeaple ≤ 20 gram \[g\]) and evaporative air assessment (Schiff sensitivity score ≥ 2) on the facial/cervical (ie, labial/buccal) tooth surface. Once the 2 test teeth were selected, the subjects were stratified (by maximum baseline Schiff sensitivity score of the 2 selected test teeth) and randomized to treatment or no treatment. DH was assessed at baseline (pre-treatment), and 10mins, 2 \& 4 hours post-treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
126
Experimental dissolvable polymer strip containing Novamin (15% weight by weight\[w/w\] calcium sodium phosphosilicate).
GSK Investigational Site
Las Vegas, Nevada, United States
Change From Baseline in Schiff Sensitivity Score After 10 Minutes
The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each test 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.
Time frame: At baseline (pre-treatment) and 10 minutes post-treatment: Day 1 of the study
Change From Baseline in Schiff Sensitivity Score After 2 and 4 Hours
The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each test 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.
Time frame: At Baseline (pre-treatment), 2 and 4 hours post-treatment: Day 1 of the study
Change From Baseline in Tactile Threshold After 10 Minutes, 2 Hours and 4 Hours
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 (pre-treatment), the maximum force used was 20g; at all subsequent time points (post treatment), it was 80g.
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Time frame: At Baseline (pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study
Change From Baseline in Numerical Rating Scale (NRS) Scores After 10 Minutes, 2 Hours and 4 Hours
Participants rated the intensity of their response to the evaporative air stimulus using a 10 point numerical rating scale of 1 (No Pain) to 10 (Intense Pain).
Time frame: At baseline(pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study