The Effects of Potassium Nitrate in Reducing Dentinal Hypersensitivity

Completed · Phase 1 · Has a placebo group

Conditions studied: Dentinal Hypersensitivity, Dental Pain

In brief

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.

Key facts

Study ID

NCT01587950

Run by

GlaxoSmithKline

People needed

12

Starts

2009-02-01

Expected to finish

2009-04-01

Last updated by the study team

2015-04-28

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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