Back to resultsThe Effects of Potassium Nitrate in Reducing Dentinal Hypersensitivity
Primary Purpose
Dentinal Hypersensitivity, Dental Pain
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Potassium Nitrate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dentinal Hypersensitivity focused on measuring dentinal sensitivity, potassium nitrate, dental pain
Eligibility Criteria
Inclusion Criteria:
- General Health and Oral Heath: Good general health and oral health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.
- Teeth: Presence of teeth in various locations in the mouth to determine stent success. Required teeth include: at least three first molars; a maxillary incisor, cuspid and bicuspid; and a mandibular incisor, cuspid and bicuspid.
- Dental Sensitivity: a) Self-reported history of dentinal hypersensitivity lasting more than 6 months and a primary complaint of sensitive teeth. b) A minimum of three accessible teeth that can be isolated that meet all of the following criteria at the screening visit: i. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. Study teeth must exhibit greater than or equal to 3mm recession at the facial surface midpoint. ii. Teeth must be visually stain and calculus free. iii. Teeth having a gingival index score less than or equal to 2. iv. Teeth with a clinical mobility of less than or equal to 1. v. 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 visual analogue scale (VAS). c) A minimum of three eligible teeth identified at the screening visit that continue to show signs of sensitivity at the baseline assessment at treatment visit 1, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm VAS.
Exclusion Criteria:
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the stent materials (or closely related compounds) or any of their stated ingredients.
- Condition of the Dentition: a) Sensitive teeth not expected to respond to treatment with an over-the-counter (OTC) dentifrice in the opinion of the investigator. b) 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 aetiologies other than erosion, abrasion or recession of exposed dentine.
Sites / Locations
- University Park Research Center (UPRC)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Sterile water
Potassium nitrate 5% solution
Potassium nitrate 2.5% solution
Arm Description
Participants to receive 250 microlitres (μL) of sterile water.
Participants to receive 250 μL of potassium nitrate 5% solution.
Participants to receive 250 μL of potassium nitrate 2.5% solution.
Outcomes
Primary Outcome Measures
Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score immediately post treatment.
Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 10 minutes post treatment.
Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 20 minutes post treatment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01587950
Brief Title
The Effects of Potassium Nitrate in Reducing Dentinal Hypersensitivity
Official Title
An Exploratory Study Investigating the Effects of a Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized, controlled, double blind exploratory study to explore the effects of two different potassium nitrate concentrations and water on exposed dentine in reducing dentinal hypersensitivity. Solutions will be applied for either 2, 5 or 10 minutes and assessed by visual analogue scale (VAS) scores following evaporative (air) stimulus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentinal Hypersensitivity, Dental Pain
Keywords
dentinal sensitivity, potassium nitrate, dental pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sterile water
Arm Type
Placebo Comparator
Arm Description
Participants to receive 250 microlitres (μL) of sterile water.
Arm Title
Potassium nitrate 5% solution
Arm Type
Experimental
Arm Description
Participants to receive 250 μL of potassium nitrate 5% solution.
Arm Title
Potassium nitrate 2.5% solution
Arm Type
Experimental
Arm Description
Participants to receive 250 μL of potassium nitrate 2.5% solution.
Intervention Type
Drug
Intervention Name(s)
Potassium Nitrate
Intervention Description
250 μL of Potassium nitrate solution (either 5% or 2.5%)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sterile Water
Primary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Description
Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score immediately post treatment.
Time Frame
Baseline, immediately post administration of treatment
Title
Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Description
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 10 minutes post treatment.
Time Frame
Baseline, 10 minutes post administration of treatment
Title
Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Description
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 20 minutes post treatment.
Time Frame
Baseline, 20 minutes post administration of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
General Health and Oral Heath: Good general health and oral health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.
Teeth: Presence of teeth in various locations in the mouth to determine stent success. Required teeth include: at least three first molars; a maxillary incisor, cuspid and bicuspid; and a mandibular incisor, cuspid and bicuspid.
Dental Sensitivity: a) Self-reported history of dentinal hypersensitivity lasting more than 6 months and a primary complaint of sensitive teeth. b) A minimum of three accessible teeth that can be isolated that meet all of the following criteria at the screening visit: i. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. Study teeth must exhibit greater than or equal to 3mm recession at the facial surface midpoint. ii. Teeth must be visually stain and calculus free. iii. Teeth having a gingival index score less than or equal to 2. iv. Teeth with a clinical mobility of less than or equal to 1. v. 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 visual analogue scale (VAS). c) A minimum of three eligible teeth identified at the screening visit that continue to show signs of sensitivity at the baseline assessment at treatment visit 1, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm VAS.
Exclusion Criteria:
Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the stent materials (or closely related compounds) or any of their stated ingredients.
Condition of the Dentition: a) Sensitive teeth not expected to respond to treatment with an over-the-counter (OTC) dentifrice in the opinion of the investigator. b) 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 aetiologies other than erosion, abrasion or recession of exposed dentine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
University Park Research Center (UPRC)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
12. IPD Sharing Statement
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The Effects of Potassium Nitrate in Reducing Dentinal Hypersensitivity
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