Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Dentine Hypersensitivity

Treatments: Other: Sterile water; Drug: 2.5% Potassium nitrate; Drug: 5% Potassium nitrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01115452

Z3770633

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 3 patient groups, including a placebo group

5% KNO3 solution

Experimental group

Description:

Participants to apply 5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period.

Treatment:

Drug: 5% Potassium nitrate

2.5% KNO3 solution

Experimental group

Description:

Participants to apply 2.5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period.

Treatment:

Drug: 2.5% Potassium nitrate

Drug: 5% Potassium nitrate

Sterile Water

Placebo Comparator group

Description:

Participants to apply sterile water to a single sensitive tooth for two minutes, in each of the five day treatment period.

Treatment:

Other: Sterile water