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
Study complete
Study complete
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:
Enrollment:
32
Primary completion date:
2009-31-10
Observational study model:
Not applicable
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
Study complete
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website