Clinical trial NCT01115452: Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity
Official title: A Proof of Principle Study Investigating the Effects of a Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dentine Hypersensitivity
Keywords: potassium nitrate
tooth sensitivity
dentin sensitivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Baseline and immediately after treatment on Day 5
Secondary outcomes:
measure: 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
timeFrame: Baseline and immediately after treatment on Day 1
measure: 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
timeFrame: Baseline and 10 mins post treatment on Day 1
measure: 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.
timeFrame: Baseline and 20 mins post treatment on Day 1
measure: Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS
timeFrame: Baseline and immediately after treatment on Day 2
measure: 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
timeFrame: Baseline and 10 mins post treatment on Day 2
measure: 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
timeFrame: Baseline and 20 mins post treatment on Day 2
measure: 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
timeFrame: Baseline and immediately after treatment on Day 3
measure: 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
timeFrame: Baseline and 10 mins post treatment on Day 3
measure: 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
timeFrame: Baseline and 20 mins post treatment on Day 3
measure: Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS
timeFrame: Baseline and immediately after treatment on Day 4
measure: 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
timeFrame: Baseline and 10 mins post treatment on Day 4
measure: 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
timeFrame: Baseline and 20 mins post treatment on Day 4
measure: 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
timeFrame: Baseline and immediately after treatment on Day 5
measure: 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
timeFrame: Baseline and 10 mins post treatment on Day 5
measure: 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
timeFrame: Baseline and 20 mins post treatment on Day 5
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: University Park Research Center (UPRC)
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: