The purpose of this study is to investigate and characterize the Dentine Hypersensitivity (DH) protection profiles of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste and a regular fluoride toothpaste, in response to evaporative air (Schiff sensitivity score) and tactile (tactile threshold in grams \[g\]) stimuli, with twice daily brushing over 2 weeks.
This will be a single center, randomized, controlled, examiner-blind, 2-arm, stratified, parallel design clinical study in healthy male and female participants, aged 18-70 years, with self-reported and clinically confirmed DH. Participants who meet the required study criteria at screening and baseline will be randomized to one of two study toothpastes: 0.454% SnF2 toothpaste (Test) or a regular fluoride toothpaste (Negative Control). Sufficient participants will be screened to ensure approximately 80 participants are randomized to study toothpaste (approximately 40 participants per group) and approximately 70 participants complete the study (approximately 35 participants per group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
85
Toothpaste containing 0.454 % weight/weight (w/w) SnF2 (1100 parts per million \[ppm\] fluoride).
A regular fluoride toothpaste containing 1000 ppm fluoride.
University of Bristol, Bristol Dental School and Hospital
Bristol, United Kingdom
Least Square (LS) Mean Change from Baseline in Schiff Sensitivity Score at Day 15
Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. LS means of change from baseline at Day 15 will be estimated using a Mixed Model with Repeated Measures (MMRM). A decrease in Schiff sensitivity score indicates an improvement.
Time frame: Baseline (Day 1) and Day 15
LS Mean Change from Baseline in Tactile Threshold at Day 15
The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. At baseline the upper test limit is 20 g and at Day 15, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Tactile threshold= average value for the two 'test teeth' identified at baseline. LS means of change from baseline at Day 15 will be estimated using a MMRM.
Time frame: Baseline (Day 1) and Day 15
Schiff Sensitivity Score at Baseline, Day 2, Day 8, and Day 15
Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. A decrease in Schiff sensitivity score indicates an improvement.
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Time frame: Baseline (Day 1), Days 2, 8 and 15
Tactile Threshold at Baseline, Day 2, Day 8, and Day 15
The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. At baseline the upper test limit is 20 g and at Day 2, 8 and 15, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Tactile threshold= average value for the two 'test teeth' identified at baseline.
Time frame: Baseline (Day 1), Days 2, 8 and 15
Change From Baseline in Schiff Sensitivity Score at Day 2, Day 8, and Day 15
Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. Change from baseline will be calculated by subtracting baseline score from the score at the indicated timepoints. A decrease in Schiff sensitivity score indicates an improvement.
Time frame: Baseline (Day 1), Days 2, 8 and 15
Change From Baseline in Tactile Threshold at Day 2, Day 8, and Day 15
The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. At baseline the upper test limit is 20 g and at Day 15, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Tactile threshold= average value for the two 'test teeth' identified at baseline. Change from baseline will be calculated by subtracting LS mean baseline score from the score at the indicated timepoints.
Time frame: Baseline (Day 1), Days 2, 8 and 15
LS Mean Change from Baseline in Schiff Sensitivity Score at Day 2 and Day 8
Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. LS means of change from baseline at the indicated timepoints will be estimated using a MMRM. A decrease in Schiff sensitivity score indicates an improvement.
Time frame: Baseline (Day 1), Days 2 and 8
LS Mean Change from Baseline in Tactile Threshold (g) at Day 2 and Day 8
The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. At baseline the upper test limit is 20 g and at Day 15, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Tactile threshold= average value for the two 'test teeth' identified at baseline. LS means of change from baseline at the indicated timepoints will be estimated using a MMRM.
Time frame: Baseline (Day 1), Days 2 and 8
LS Mean Change from Baseline in Schiff Sensitivity Score at Day 2, Day 8 and Day 15 (Test Versus [Vs] Negative Control)
Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. LS means of change from baseline at the indicated timepoints will be estimated using a MMRM. A decrease in Schiff sensitivity score indicates an improvement.
Time frame: Baseline (Day 1), Days 2, 8 and 15
LS Mean Change from Baseline in Tactile Threshold (g) at Day 2, Day 8 and Day 15 (Test Vs Negative Control)
The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. At baseline the upper test limit is 20 g and at Day 15, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Tactile threshold= average value for the two 'test teeth' identified at baseline. LS means of change from baseline at the indicated timepoints will be estimated using a MMRM.
Time frame: Baseline (Day 1), Days 2, 8 and 15