Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

Study Overview
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Brief Summary
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An exploratory study investigating the direct application of potassium nitrate (KNO3) solutions of different concentrations in reducing dentine hypersensitivity.

Official Title
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A Proof of Principle Study Investigating the Effects of a Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

Conditions
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Dentine Hypersensitivity

Intervention / Treatment
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* Drug: 5% Potassium nitrate
* Drug: 2.5% Potassium nitrate
* Other: Sterile water


Participation Criteria
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Eligibility Criteria
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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

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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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5% KNO3 solution<br>Participants to apply 5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period. | Drug: 5% Potassium nitrate<br>* 5% potassium nitrate solution<br>|
| Experimental: 2.5% KNO3 solution<br>Participants to apply 2.5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period. | Drug: 5% Potassium nitrate<br>* 5% potassium nitrate solution<br>Drug: 2.5% Potassium nitrate<br>* 2.5% potassium nitrate solution<br>|
| Placebo Comparator: Sterile Water<br>Participants to apply sterile water to a single sensitive tooth for two minutes, in each of the five day treatment period. | Other: Sterile water<br>* Sterile water<br>|

What is the study measuring?
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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 | 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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potassium nitrate, tooth sensitivity, dentin sensitivity