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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Immune System Diseases
Stomatognathic Diseases
Tooth Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014