The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity

Study Overview
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Brief Summary
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A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over an eight week treatment period.

Official Title
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A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity

Conditions
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Dentine Hypersensitivity

Intervention / Treatment
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* Drug: Stannous Fluoride
* Drug: Sodium Monofluorophosphate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who suffer from tooth sensitivity Inclusion Criteria: - none

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Dentifrice containing stannous fluoride | Drug: Stannous Fluoride<br>* dentifice<br>|
| Active Comparator: Arm 2<br>Marketed dentifrice containing Sodium Monofluorophosphate | Drug: Sodium Monofluorophosphate<br>* dentifrice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8 | Response to a constant jet of air applied to hypersensitive teeth is 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. | Baseline to 8 weeks post administration of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a 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. | Baseline to 4 weeks post administration of study treatment | 
| Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8 | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10 grams (g) to an upper threshold of 80 g, in increments of 10g since the values below represents adjusted mean change in baseline, the value can fall below scale range. The greater the pressure the subject was able to tolerate, the less. Change from baseline in tactile response to Week 8 was calculated. sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. | Baseline to 8 weeks post administration of study treatment | 
| Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4 | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the subject was able to tolerate, the less sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. Change from baseline in tactile response to Week 4 was calculated | Baseline to 4 weeks post administration of study treatment |