Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Pharmaceutical Solutions

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