Dentine Hypersensitivity Clinical Trial
Official title:
A Proof of Principle Study Investigating the Effects of a Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity
Verified date | January 2015 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
An exploratory study investigating the direct application of potassium nitrate (KNO3) solutions of different concentrations in reducing dentine hypersensitivity.
Status | Completed |
Enrollment | 32 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University Park Research Center (UPRC) | Fort Wayne | Indiana |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and immediately after treatment on Day 5 | No |
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and immediately after treatment on Day 1 | No |
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 10 mins post treatment on Day 1 | No |
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. | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 20 mins post treatment on Day 1 | No |
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and immediately after treatment on Day 2 | No |
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 10 mins post treatment on Day 2 | No |
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 20 mins post treatment on Day 2 | No |
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and immediately after treatment on Day 3 | No |
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 10 mins post treatment on Day 3 | No |
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 20 mins post treatment on Day 3 | No |
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and immediately after treatment on Day 4 | No |
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 10 mins post treatment on Day 4 | No |
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 20 mins post treatment on Day 4 | No |
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and immediately after treatment on Day 5 | No |
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 10 mins post treatment on Day 5 | No |
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 | Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline. | Baseline and 20 mins post treatment on Day 5 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01426360 -
Instant and Lasting Relief Effects of Strontium Chloride/Potassium Nitrate Dentifrice on Dentin Hypersensitivity
|
N/A | |
Completed |
NCT02931734 -
Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment
|
N/A | |
Recruiting |
NCT03177109 -
Comparison of Different Desensitizers in Reducing Dentinal Hypersensitivity
|
Phase 3 | |
Completed |
NCT06197555 -
Comparision of the Clinical Efficacy of Different Desensitizing Toothpastes
|
N/A | |
Completed |
NCT01724008 -
The Efficacy of a Dentifrice in Providing Relief From Dentinal Hypersensitivity
|
Phase 3 | |
Completed |
NCT01592864 -
The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity
|
Phase 3 | |
Recruiting |
NCT03076944 -
Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity
|
N/A | |
Recruiting |
NCT03083496 -
Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin Hypersensitivity Treatment
|
N/A | |
Completed |
NCT03072719 -
The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity
|
Phase 3 | |
Completed |
NCT03515902 -
The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity
|
N/A | |
Completed |
NCT04754763 -
A Comparative Study On The Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
|
Early Phase 1 | |
Completed |
NCT02929043 -
Psychophysical Characterization and Brain Correlates of Dentine Hypersensitivity
|
N/A | |
Completed |
NCT04005417 -
Meta-analysis of Stannous Fluoride Dentifrice and the Effects on Dentine Hypersensitivity
|
||
Not yet recruiting |
NCT04179994 -
Efficacy of Miswak Extract Toothpaste as Compared Potassium Nitrate in The Management of Dentinal Hypersensitivity
|
N/A | |
Completed |
NCT01827670 -
Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
|
Phase 3 | |
Recruiting |
NCT05392868 -
Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults
|
Phase 2 | |
Completed |
NCT01075256 -
Dose Response of a Tubule Occlusion Agent
|
Phase 4 | |
Completed |
NCT01691560 -
Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
|
Phase 2 | |
Completed |
NCT02018783 -
Single Application of Desensitizing Pastes as Dentin Sensitivity Treatment
|
N/A | |
Completed |
NCT01592851 -
Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity
|
Phase 3 |