A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site study in subjects with at least two sensitive teeth to compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Test dentifrice, participants will brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute.
Control dentifrice, participants will brush the whole mouth thoroughly for at least 1 minute.
GSK Investigational Site
Cork, Ireland
Change From Baseline in Schiff Sensitivity Score on Day 14
Schiff sensitivity score was assessed by examiner as 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. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.
Time frame: Baseline, Day 14
Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3
Schiff sensitivity score was assessed by examiner as 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. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
Time frame: Baseline, post first brushing (after 5 minutes) and Day 3
Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14
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 threshold, the less sensitive the tooth.
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Time frame: Baseline, post first brushing (after 5 minutes), Day 3 and Day 14