The Efficacy of a Dentifrice in Providing Relief From Dentinal Hypersensitivity
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01724008
First received: March 1, 2012
Last updated: November 6, 2012
Last verified: November 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Dentine Hypersensitivity |
Drug: Stannous Fluoride Drug: Sodium Monofluorophosphate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Immediate and Short Term Relief From Dentinal Hypersensitivity. |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Schiff Sensitivity Score. [ Time Frame: twice daily brushing at Day 14 ] [ Designated as safety issue: No ]compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity
Secondary Outcome Measures:
- Tactile (Yeaple) Pain Threshold [ Time Frame: twice daily brushing Day 14, Day 3 and Day 0 ] [ Designated as safety issue: No ]compare the efficacy of a test dentifrice against that of a control dentifrice in reducing tactile stimulated (grams of force, Yeaple Probe) dentinal hypersensitivity following twice daily brushing
- Schiff Sensitivity Score [ Time Frame: twice daily brushing Day 14, Day 3 and Day 0 ] [ Designated as safety issue: No ]compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity following twice daily brushing
| Enrollment: | 120 |
| Study Start Date: | March 2012 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dentifrice containing stannous fluoride
Toothpaste
|
Drug: Stannous Fluoride
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.
|
|
Active Comparator: Dentifrice containing Sodium Monofluorophosphate
Toothpaste
|
Drug: Sodium Monofluorophosphate
Control dentifrice, participants will brush the whole mouth thoroughly for at least 1 minute.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Participants who suffer from tooth sensitivity.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01724008
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724008
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01724008 History of Changes |
| Other Study ID Numbers: | RH01327 |
| Study First Received: | March 1, 2012 |
| Last Updated: | November 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Dentin Sensitivity Hypersensitivity Immune System Diseases Stomatognathic Diseases Tooth Diseases |
Fluorophosphate Cariostatic Agents Pharmacologic Actions Physiological Effects of Drugs Protective Agents |
ClinicalTrials.gov processed this record on March 03, 2015