Last updated: 11/04/2018 13:50:17
Efficacy of potassium nitrate solution in reducing dentinal hypersensitivity
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A proof of principle study investigating the effects of a potassium nitrate solution in reducing dentinal hypersensitivity
Trial description: An exploratory study investigating the direct application of potassium nitrate (KNO3) solutions of different concentrations in reducing dentine hypersensitivity.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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:
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Interventions:
Drug: 5% Potassium nitrate
Drug: 2.5% Potassium nitrate
Other: Sterile water
Enrollment:
32
Observational study model:
Not applicable
Primary completion date:
2009-31-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dentine Hypersensitivity
Product
potassium nitrate
Collaborators
Not applicable
Study date(s)
September 2009 to October 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- 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:
- 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
Inclusion and exclusion 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
Trial location(s)
Location
University Park Research Center (UPRC)
Fort Wayne, IN, United States, 46825
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-31-10
Actual study completion date
2009-31-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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