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

April 30, 2010
January 25, 2012
September 2009
October 2009   (final data collection date for primary outcome measure)
Change from baseline dentinal hypersensitivity after post evaporative (air) stimulus [ Time Frame: Baseline to 5 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01115452 on ClinicalTrials.gov Archive Site
Change from baseline dentinal hypersensitivity after post evaporative (air) stimulus [ Time Frame: Baseline through 5 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity
A Proof of Principle Study Investigating the Effects of a Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dentin Sensitivity
  • Drug: Higher level potassium nitrate solution
    Higher level potassium nitrate solution
  • Drug: Lower level potassium nitrate solution
    Lower level potassium nitrate solution
  • Other: Sterile water
    Sterile water
  • Experimental: Higher level potassium nitrate solution
    Intervention: Drug: Higher level potassium nitrate solution
  • Experimental: Lower level potassium nitrate solution
    Intervention: Drug: Lower level potassium nitrate solution
  • Sterile Water
    Intervention: Other: Sterile water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01115452
Z3770633
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP