Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

Dentine Hypersensitivity Clinical Trial

Official title:

A Proof of Principle Study Investigating the Effects of a Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115452
• Other study ID #: Z3770633
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2010
• Last updated: January 22, 2015
• Start date: September 2009
• Est. completion date: October 2009

Study information

• Verified date: January 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentin Sensitivity
• Dentine Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• 5% Potassium nitrate
5% potassium nitrate solution
• 2.5% Potassium nitrate
2.5% potassium nitrate solution

Other:
• Sterile water
Sterile water

Locations

Country	Name	City	State
United States	University Park Research Center (UPRC)	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a Visual Analog Scale (VAS) in 5% Potassium Nitrate Solution and 2.5% Potassium Nitrate Solution	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and immediately after treatment on Day 5	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 1 Using a VAS	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and immediately after treatment on Day 1	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 1 Using a VAS	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and 10 mins post treatment on Day 1	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 1 Using a VAS.	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and 20 mins post treatment on Day 1	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and immediately after treatment on Day 2	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 2 Using a VAS	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and 10 mins post treatment on Day 2	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 2 Using a VAS	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and 20 mins post treatment on Day 2	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 3 Using a VAS	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and immediately after treatment on Day 3	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 3 Using a VAS	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and 10 mins post treatment on Day 3	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 3 Using a VAS	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and 20 mins post treatment on Day 3	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and immediately after treatment on Day 4	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 4 Using a VAS	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and 10 mins post treatment on Day 4	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli 20 Mins Post Treatment on Day 4 Using a VAS	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and 20 mins post treatment on Day 4	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a VAS in 5% Potassium Nitrate Solution and Water; 2.5% Potassiun Nitrate Solution and Water	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and immediately after treatment on Day 5	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 5 Using a VAS	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and 10 mins post treatment on Day 5	No
Secondary	Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 5 Using a VAS	Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.	Baseline and 20 mins post treatment on Day 5	No