The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity
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ClinicalTrials.gov Identifier: NCT01592864 |
Recruitment Status :
Completed
First Posted : May 7, 2012
Results First Posted : March 10, 2014
Last Update Posted : March 10, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dentine Hypersensitivity | Drug: Stannous Fluoride Drug: Sodium Monofluorophosphate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm 1
Dentifrice containing stannous fluoride
|
Drug: Stannous Fluoride
dentifice |
Active Comparator: Arm 2
Marketed dentifrice containing Sodium Monofluorophosphate
|
Drug: Sodium Monofluorophosphate
dentifrice |
- Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8 [ Time Frame: Baseline to 8 weeks post administration of study treatment ]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.
- Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4 [ Time Frame: Baseline to 4 weeks post administration of study treatment ]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.
- Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8 [ Time Frame: Baseline to 8 weeks post administration of study treatment ]
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.
- Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4 [ Time Frame: Baseline to 4 weeks post administration of study treatment ]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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subjects who suffer from tooth sensitivity
Inclusion Criteria:
- none

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592864
United States, Nevada | |
BioSci Research America, Inc. | |
Las Vegas, Nevada, United States, 89121 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01592864 |
Other Study ID Numbers: |
RH01325 |
First Posted: | May 7, 2012 Key Record Dates |
Results First Posted: | March 10, 2014 |
Last Update Posted: | March 10, 2014 |
Last Verified: | December 2013 |
Dentin Sensitivity Hypersensitivity Immune System Diseases Tooth Diseases Stomatognathic Diseases Fluorides |
Tin Fluorides Fluorophosphate Cariostatic Agents Protective Agents Physiological Effects of Drugs |