Phase 2
N=32
Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity
Dentine Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT01115452 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: 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 — -24.36; -24.04 units on a scale — p=0.9347
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 5% Potassium nitrate (Drug); 2.5% Potassium nitrate (Drug); Sterile water (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
-24.36; -24.04 | 0.9347 |
| 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 |
-8.18; -8.20; -12.08 | 0.9963 |
| 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 |
-13.38; -12.47; -12.48 | 0.8265 |
| 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. |
-17.42; -21.64; -16.15 | 0.3122 |
| 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 |
-11.66; -10.31; -12.32 | 0.7472 |
| 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 |
-18.09; -16.14; -18.52 | 0.6417 |
| 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 |
-20.39; -16.81; -18.69 | 0.3930 |
| 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 |
-16.66; -14.58; -14.90 | 0.6301 |
| 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 |
-23.29; -20.71; -21.20 | 0.5504 |
| 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 |
-24.86; -22.71; -25.46 | 0.6192 |
| 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 |
-21.89; -18.52; -22.63 | 0.4055 |
| 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 |
-21.09; -24.32; -22.13 | 0.4264 |
| 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 |
-27.92; -22.78; -27.53 | 0.2059 |
| 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 |
-24.36; -24.04; -25.48 | 0.7822 |
| 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 |
-27.83; -26.47; -28.88 | 0.7318 |
| 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 |
-30.93; -30.20; -30.78 | 0.8549 |
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
Data sourced from ClinicalTrials.gov (NCT01115452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.