Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 26, 2008
CompletedFirst Posted
Study publicly available on registry
February 19, 2010
CompletedResults Posted
Study results publicly available
February 19, 2010
CompletedJune 14, 2011
June 1, 2011
1 month
September 26, 2008
September 26, 2008
June 10, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Immediately after product application
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.
Immediately after product application
Study Arms (2)
ProClude Prophylaxis paste-A
ACTIVE COMPARATORArginine Bicarbonate prophylaxis paste
Nupro-M Prophylaxis paste -B
PLACEBO COMPARATORControl prophylaxis paste (Fluoride free - placebo)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Contract Dental Evaluations
Langhorne, Pennsylvania, 19047, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- William DeVizio - DMD
- Organization
- Colgate Palmolive
Study Officials
- PRINCIPAL INVESTIGATOR
David Hamlin, DDS
Contract Dental Evaluations
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 26, 2008
First Posted
February 19, 2010
Study Start
July 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
June 14, 2011
Results First Posted
February 19, 2010
Record last verified: 2011-06