This will be a single center, eight week, randomized, double blind, three treatment arm, parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected test teeth) study in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
221
1.5% w/w KOX, 0ppm F, pH 7.0
2.0% w/w KOX, 45ppm F, pH 4.5
0% w/w KOX 0ppm F, pH 4.5
GSK Investigational Site
Fort Wayne, Indiana, United States
Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 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.
Time frame: Baseline and Week 8
Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 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.
Time frame: Baseline and Week 8
Change From Baseline in Schiff Sensitivity Score at Week 4
Schiff sensitivity score was assessed as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, using scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of syimulus; 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.
Time frame: Baseline and Week 4
Change From Baseline in Tactile Threshold at Week 4 and 8
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Pressure was administered using a constant pressure probe (Yeaple Probe). The constant pressure probe allows the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant reporting 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 greater the tactile threshold, the less sensitive the tooth.
Time frame: Baseline, Week 4 and 8
Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8
Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The subjects were asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain").
Time frame: Baseline, Week 4 and 8