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Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT01072188
First received: September 26, 2008
Last updated: June 10, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Hypersensitivity
Device: Arginine/Calcium Carbonate
Device: Nupro - Fluoride Free
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste

Resource links provided by NLM:


Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Hypersensitivity to Touch (Tactile) [ Time Frame: Immediately after product application ] [ Designated as safety issue: No ]
    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 [ Time Frame: Immediately after product application ] [ Designated as safety issue: No ]
    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.


Enrollment: 45
Study Start Date: July 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072188

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

No publications provided

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT01072188     History of Changes
Other Study ID Numbers: CRO-2008-07-SEN-PROPREC-ED
Study First Received: September 26, 2008
Results First Received: September 26, 2008
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Calcium Carbonate
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014