Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01072188
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : February 19, 2010
Last Update Posted : June 14, 2011
Information provided by:
Colgate Palmolive

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.

Condition or disease Intervention/treatment Phase
Hypersensitivity Device: Arginine/Calcium Carbonate Device: Nupro - Fluoride Free Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste
Study Start Date : July 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: ProClude Prophylaxis paste-A
Arginine Bicarbonate prophylaxis paste
Device: Arginine/Calcium Carbonate
One time treatment
Placebo Comparator: Nupro-M Prophylaxis paste -B
Control prophylaxis paste (Fluoride free - placebo)
Device: Nupro - Fluoride Free
Brush twice daily

Primary Outcome Measures :
  1. Hypersensitivity to Touch (Tactile) [ Time Frame: Immediately after product application ]
    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.

  2. Air Blast [ Time Frame: Immediately after product application ]
    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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01072188

United States, Pennsylvania
Contract Dental Evaluations
Langhorne, Pennsylvania, United States, 19047
Sponsors and Collaborators
Colgate Palmolive
Principal Investigator: David Hamlin, DDS Contract Dental Evaluations

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive Identifier: NCT01072188     History of Changes
Other Study ID Numbers: CRO-2008-07-SEN-PROPREC-ED
First Posted: February 19, 2010    Key Record Dates
Results First Posted: February 19, 2010
Last Update Posted: June 14, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Immune System Diseases
Calcium Carbonate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents