The Effects of Potassium Nitrate in Reducing Dentinal Hypersensitivity

Study Overview
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Brief Summary
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A randomized, controlled, double blind exploratory study to explore the effects of two different potassium nitrate concentrations and water on exposed dentine in reducing dentinal hypersensitivity. Solutions will be applied for either 2, 5 or 10 minutes and assessed by visual analogue scale (VAS) scores following evaporative (air) stimulus.

Official Title
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An Exploratory Study Investigating the Effects of a Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

Conditions
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Dentinal Hypersensitivity, Dental Pain

Intervention / Treatment
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* Drug: Potassium Nitrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Health and Oral Heath: Good general health and oral health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history. Teeth: Presence of teeth in various locations in the mouth to determine stent success. Required teeth include: at least three first molars; a maxillary incisor, cuspid and bicuspid; and a mandibular incisor, cuspid and bicuspid. Dental Sensitivity: a) Self-reported history of dentinal hypersensitivity lasting more than 6 months and a primary complaint of sensitive teeth. b) A minimum of three accessible teeth that can be isolated that meet all of the following criteria at the screening visit: i. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. Study teeth must exhibit greater than or equal to 3mm recession at the facial surface midpoint. ii. Teeth must be visually stain and calculus free. iii. Teeth having a gingival index score less than or equal to 2. iv. Teeth with a clinical mobility of less than or equal to 1. v. 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 visual analogue scale (VAS). c) A minimum of three eligible teeth identified at the screening visit that continue to show signs of sensitivity at the baseline assessment at treatment visit 1, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm VAS. Exclusion Criteria: Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the stent materials (or closely related compounds) or any of their stated ingredients. Condition of the Dentition: a) Sensitive teeth not expected to respond to treatment with an over-the-counter (OTC) dentifrice in the opinion of the investigator. b) 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 aetiologies other than erosion, abrasion or recession of exposed dentine.

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sterile water<br>Participants to receive 250 microlitres (μL) of sterile water. | Drug: Placebo<br>* Sterile Water<br>|
| Experimental: Potassium nitrate 5% solution<br>Participants to receive 250 μL of potassium nitrate 5% solution. | Drug: Potassium Nitrate<br>* 250 μL of Potassium nitrate solution (either 5% or 2.5%)<br>|
| Experimental: Potassium nitrate 2.5% solution<br>Participants to receive 250 μL of potassium nitrate 2.5% solution. | Drug: Potassium Nitrate<br>* 250 μL of Potassium nitrate solution (either 5% or 2.5%)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water | Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score immediately post treatment. | Baseline, immediately post administration of treatment | 
| Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 10 minutes post treatment. | Baseline, 10 minutes post administration of treatment | 
| Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 20 minutes post treatment. | Baseline, 20 minutes post administration of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dentinal sensitivity, potassium nitrate, dental pain