Back to resultsClinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste
Primary Purpose
Hypersensitivity
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Arginine/Calcium Carbonate
Nupro - Fluoride Free
Sponsored by
About this trial
This is an interventional treatment trial for Hypersensitivity
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects, ages 18-70, inclusive.
- Availability for the three (3) week duration of the study.
- Two (2) sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
- Qualifying response to tactile stimuli (Yeaple probe) as defined by a score between 10-50gms. of force.
- Qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
- Subjects need to satisfy the qualifying response to stimuli for both the parameters assessed (tactile or air) on two teeth to be entered into the study.
- Good general health with no known allergies to products being tested.
- Use of a non-desensitizing dentifrice for three months prior to entry into the study.
- Signed Informed Consent Form.
Exclusion Criteria:
- Gross oral pathology, chronic disease, or history of allergy to test products.
- Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
- Scheduled dental prophylaxis within three weeks prior to the Baseline Hypersensitivity Examination.
- Sensitive teeth with mobility greater than one.
- Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
- Subjects that began to take anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily analgesics within one month prior to the start of the study or who have to start taking these during the course of the study.
- Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months.
- Current participation in any other clinical study.
- Pregnant or lactating subjects.
- Allergies to oral care products, personal care consumer products, or their ingredients.
- Medical condition which prohibits not eating/drinking for 4 hours.
Sites / Locations
- Contract Dental Evaluations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ProClude Prophylaxis paste-A
Nupro-M Prophylaxis paste -B
Arm Description
Arginine Bicarbonate prophylaxis paste
Control prophylaxis paste (Fluoride free - placebo)
Outcomes
Primary Outcome Measures
Hypersensitivity to Touch (Tactile)
Units on a scale: Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. The higher the score, the higher the hypersensitivity.
Air Blast
Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01072188
Brief Title
Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste
Official Title
Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Colgate Palmolive
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the clinical efficacy of a prophylaxis paste containing 10% arginine bicarbonate on dentinal hypersensitivity reduction when applied as a pre-procedure to a professional dental cleaning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ProClude Prophylaxis paste-A
Arm Type
Active Comparator
Arm Description
Arginine Bicarbonate prophylaxis paste
Arm Title
Nupro-M Prophylaxis paste -B
Arm Type
Placebo Comparator
Arm Description
Control prophylaxis paste (Fluoride free - placebo)
Intervention Type
Device
Intervention Name(s)
Arginine/Calcium Carbonate
Intervention Description
One time treatment
Intervention Type
Device
Intervention Name(s)
Nupro - Fluoride Free
Intervention Description
Brush twice daily
Primary Outcome Measure Information:
Title
Hypersensitivity to Touch (Tactile)
Description
Units on a scale: Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. The higher the score, the higher the hypersensitivity.
Time Frame
Immediately after product application
Title
Air Blast
Description
Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested.
Time Frame
Immediately after product application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female subjects, ages 18-70, inclusive.
Availability for the three (3) week duration of the study.
Two (2) sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
Qualifying response to tactile stimuli (Yeaple probe) as defined by a score between 10-50gms. of force.
Qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
Subjects need to satisfy the qualifying response to stimuli for both the parameters assessed (tactile or air) on two teeth to be entered into the study.
Good general health with no known allergies to products being tested.
Use of a non-desensitizing dentifrice for three months prior to entry into the study.
Signed Informed Consent Form.
Exclusion Criteria:
Gross oral pathology, chronic disease, or history of allergy to test products.
Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
Scheduled dental prophylaxis within three weeks prior to the Baseline Hypersensitivity Examination.
Sensitive teeth with mobility greater than one.
Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
Subjects that began to take anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily analgesics within one month prior to the start of the study or who have to start taking these during the course of the study.
Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months.
Current participation in any other clinical study.
Pregnant or lactating subjects.
Allergies to oral care products, personal care consumer products, or their ingredients.
Medical condition which prohibits not eating/drinking for 4 hours.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hamlin, DDS
Organizational Affiliation
Contract Dental Evaluations
Official's Role
Principal Investigator
Facility Information:
Facility Name
Contract Dental Evaluations
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste
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