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Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction (Yeaple)

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ClinicalTrials.gov Identifier: NCT01040169
Recruitment Status : Completed
First Posted : December 29, 2009
Results First Posted : December 29, 2009
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Brief Summary:
Tooth sensitivity reduction after dentifrices use

Condition or disease Intervention/treatment Phase
Hypersensitivity Device: Arginine/Calcium Carbonate Device: Mint Prophy paste - Fluoride free Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction
Study Start Date : May 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
Placebo Comparator: Nupro C Prophylaxis paste
Fluoride Free
Device: Mint Prophy paste - Fluoride free
one application
Other Name: Nupro C Prophylaxis paste - Fluoride free
Experimental: ProClude Prophylaxis paste
Arginine
Device: Arginine/Calcium Carbonate
One application



Primary Outcome Measures :
  1. Tooth Hypersensitity to Touch Stimuli (Tactile) [ Time Frame: 12 weeks (Final) ]
    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 is felt. This calibrated instrument measures grams of force applied to each tooth before pain is felt. This data is recorded as the hypersensitivity score. The lower the score, the higher the hypersensitivity.Changes in this score to potentially painful stimulus are determined based on how many grams of force can be applied before the subject reports feeling pain. Grams of force is therefore the unit measurement for sensitivity

  2. Tooth Hypersensivity Stimuli to Air [ Time Frame: 12 weeks (Final) ]
    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
Criteria

Inclusion Criteria:

  • Male and female subjects, ages 18-70, inclusive.
  • Availability for the three month duration of the study.
  • Two 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.
  • 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 ClinicalTrials.gov identifier (NCT number): NCT01040169


Locations
United States, California
Jacobsen Dental Clinic
San Francisco, California, United States, 94115
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Thomas Schiff, DMD

Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT01040169     History of Changes
Other Study ID Numbers: CRO-0308-SF-PROC-SEN-ED
First Posted: December 29, 2009    Key Record Dates
Results First Posted: December 29, 2009
Last Update Posted: December 10, 2013
Last Verified: November 2013

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