Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

NCT ID: NCT01115452

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2009-10-31

Brief Summary

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

Conditions

Dentine Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

5% KNO3 solution

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

Group Type: EXPERIMENTAL

5% Potassium nitrate

Intervention Type: DRUG

5% potassium nitrate solution

2.5% KNO3 solution

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

Group Type: EXPERIMENTAL

5% Potassium nitrate

Intervention Type: DRUG

5% potassium nitrate solution

2.5% Potassium nitrate

Intervention Type: DRUG

2.5% potassium nitrate solution

Sterile Water

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

Group Type: PLACEBO_COMPARATOR

Sterile water

Intervention Type: OTHER

Sterile water

Interventions

5% Potassium nitrate

5% potassium nitrate solution

Intervention Type: DRUG

2.5% Potassium nitrate

2.5% potassium nitrate solution

Intervention Type: DRUG

Sterile water

Sterile water

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

University Park Research Center (UPRC)

Fort Wayne, Indiana, United States

Countries

United States

Other Identifiers

Z3770633

Identifier Type: -

Identifier Source: org_study_id