Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

Completed · Phase 2

Conditions studied: Dentine Hypersensitivity

In brief

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

Key facts

Study ID

NCT01115452

Run by

GlaxoSmithKline

People needed

32

Starts

2009-09-01

Expected to finish

2009-10-01

Last updated by the study team

2015-01-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Park Research Center (UPRC) — Fort Wayne, Indiana, United States

Full record on ClinicalTrials.gov

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