Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01115452
First received: April 30, 2010
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Dentin Sensitivity
Drug: Higher level potassium nitrate solution
Drug: Lower level potassium nitrate solution
Other: Sterile water
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Proof of Principle Study Investigating the Effects of a Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline dentinal hypersensitivity after post evaporative (air) stimulus [ Time Frame: Baseline to 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline dentinal hypersensitivity after post evaporative (air) stimulus [ Time Frame: Baseline through 5 days ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: September 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Higher level potassium nitrate solution Drug: Higher level potassium nitrate solution
Higher level potassium nitrate solution
Experimental: Lower level potassium nitrate solution Drug: Lower level potassium nitrate solution
Lower level potassium nitrate solution
Sterile Water Other: Sterile water
Sterile water

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115452

Locations
United States, Indiana
University Park Research Center (UPRC)
Fort Wayne, Indiana, United States, 46825
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01115452     History of Changes
Other Study ID Numbers: Z3770633
Study First Received: April 30, 2010
Last Updated: January 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
potassium nitrate
dentin sensitivity
tooth sensitivity

Additional relevant MeSH terms:
Dentin Sensitivity
Hypersensitivity
Tooth Diseases
Stomatognathic Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 21, 2014