The Effects of Potassium Nitrate in Reducing Dentinal Hypersensitivity
Condition: Dentinal Hypersensitivity; Dental Pain
MeSH terms: Toothache; Hypersensitivity
Intervention: Potassium Nitrate; Placebo
Intervention description: 250 μL of Potassium nitrate solution (either 5% or 2.5%); Sterile Water
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: dentinal sensitivity; potassium nitrate; dental pain

Summary:

      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.
    

Eligibility criteria:

        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.