- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01115452
Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity
January 22, 2015 updated by: GlaxoSmithKline
A Proof of Principle Study Investigating the Effects of a Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity
An exploratory study investigating the direct application of potassium nitrate (KNO3) solutions of different concentrations in reducing dentine hypersensitivity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46825
- University Park Research Center (UPRC)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Self-reported history of dentinal hypersensitivity lasting more than 6 months and a primary complaint of sensitive teeth
- Three teeth that can be isolated that meet all of the following criteria at the screening visit:
- Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. Study teeth must exhibit greater than or equal to 3 mm recession at the facial surface midpoint
- Teeth must be visually stain and calculus free
- Teeth having a gingival index score of less than or equal to 2
- Teeth with a clinical mobility less than or equal to 1
- Teeth that show signs of sensitivity, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm VAS
Exclusion Criteria:
- Chronic disease or other condition that is associated with intermittent episodes of constant daily pain, such as arthritis, low back pain, etc.
- An condition or medication that causes xerostomia as determined by investigator
- Sensitive teeth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
- Teeth with exposed dentine but with deep, defective or facial restorations
- Teeth used as abutments for fixed or removable partial dentures
- Teeth with full crowns, orthodontic bands, extensive caries or cracked enamel
- Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentine.
- Dental prophylaxis within 3 weeks of the screening visit
- Tongue or lip piercing or presence of dental implants
- Subjects not using the same brand of toothpaste for at least 4 months prior to the screening visit
- Subjects who have used desensitizing toothpaste during the 4 weeks before Treatment Visit 1
- Taking daily dose of medication which may interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquillizers, mood-altering drugs or anti-inflammatory drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 5% KNO3 solution
Participants to apply 5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period.
|
5% potassium nitrate solution
|
Experimental: 2.5% KNO3 solution
Participants to apply 2.5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period.
|
5% potassium nitrate solution
2.5% potassium nitrate solution
|
Placebo Comparator: Sterile Water
Participants to apply sterile water to a single sensitive tooth for two minutes, in each of the five day treatment period.
|
Sterile water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a Visual Analog Scale (VAS) in 5% Potassium Nitrate Solution and 2.5% Potassium Nitrate Solution
Time Frame: Baseline and immediately after treatment on Day 5
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and immediately after treatment on Day 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 1 Using a VAS
Time Frame: Baseline and immediately after treatment on Day 1
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and immediately after treatment on Day 1
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 1 Using a VAS
Time Frame: Baseline and 10 mins post treatment on Day 1
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and 10 mins post treatment on Day 1
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 1 Using a VAS.
Time Frame: Baseline and 20 mins post treatment on Day 1
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and 20 mins post treatment on Day 1
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS
Time Frame: Baseline and immediately after treatment on Day 2
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and immediately after treatment on Day 2
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 2 Using a VAS
Time Frame: Baseline and 10 mins post treatment on Day 2
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and 10 mins post treatment on Day 2
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 2 Using a VAS
Time Frame: Baseline and 20 mins post treatment on Day 2
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and 20 mins post treatment on Day 2
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 3 Using a VAS
Time Frame: Baseline and immediately after treatment on Day 3
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and immediately after treatment on Day 3
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 3 Using a VAS
Time Frame: Baseline and 10 mins post treatment on Day 3
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and 10 mins post treatment on Day 3
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 3 Using a VAS
Time Frame: Baseline and 20 mins post treatment on Day 3
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and 20 mins post treatment on Day 3
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS
Time Frame: Baseline and immediately after treatment on Day 4
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and immediately after treatment on Day 4
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 4 Using a VAS
Time Frame: Baseline and 10 mins post treatment on Day 4
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and 10 mins post treatment on Day 4
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli 20 Mins Post Treatment on Day 4 Using a VAS
Time Frame: Baseline and 20 mins post treatment on Day 4
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and 20 mins post treatment on Day 4
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a VAS in 5% Potassium Nitrate Solution and Water; 2.5% Potassiun Nitrate Solution and Water
Time Frame: Baseline and immediately after treatment on Day 5
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and immediately after treatment on Day 5
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 5 Using a VAS
Time Frame: Baseline and 10 mins post treatment on Day 5
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and 10 mins post treatment on Day 5
|
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 5 Using a VAS
Time Frame: Baseline and 20 mins post treatment on Day 5
|
Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth.
After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable".
Change from baseline was calculated as mean score at the given time point minus mean score at baseline.
|
Baseline and 20 mins post treatment on Day 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
April 30, 2010
First Submitted That Met QC Criteria
April 30, 2010
First Posted (Estimate)
May 4, 2010
Study Record Updates
Last Update Posted (Estimate)
January 26, 2015
Last Update Submitted That Met QC Criteria
January 22, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Z3770633
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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