The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.
This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth), exploratory study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, four and eight weeks to monitor clinical efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
Dentifrice containing 1000 ppmF as sodium monofluorophosphate
BioSci Research America
Las Vegas, Nevada, United States
Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4
Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.
Time frame: Baseline to 4 weeks post administration of study treatment
Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.
Time frame: Baseline to 4 weeks post administration of study treatment
Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8
Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.
Time frame: Baseline to 8 weeks post administration of study treatment
Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.
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Dentifrice containing 1100 ppmF as sodium fluoride
Time frame: Baseline to 8 weeks post administration of study treatment
Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4
Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).
Time frame: Baseline to 4 weeks post administration of study treatment
Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8
Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).
Time frame: Baseline to 8 weeks post administration of study treatment