Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity
Condition: Dentine Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: 5% Potassium nitrate; 2.5% Potassium nitrate; Sterile water
Intervention description: 5% potassium nitrate solution; 2.5% potassium nitrate solution; Sterile water
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: potassium nitrate; tooth sensitivity; dentin sensitivity

Summary:

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

Eligibility criteria:

        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