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Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction (Yeaple)

Primary Purpose

Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arginine/Calcium Carbonate
Mint Prophy paste - Fluoride free
Sponsored by
Colgate Palmolive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypersensitivity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Jacobsen Dental Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Nupro C Prophylaxis paste

ProClude Prophylaxis paste

Arm Description

Fluoride Free

Arginine

Outcomes

Primary Outcome Measures

Tooth Hypersensitity to Touch Stimuli (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 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
Tooth Hypersensivity Stimuli to Air
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

First Posted
September 27, 2008
Last Updated
November 15, 2013
Sponsor
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT01040169
Brief Title
Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction
Acronym
Yeaple
Official Title
Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colgate Palmolive

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Tooth sensitivity reduction after dentifrices use

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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nupro C Prophylaxis paste
Arm Type
Placebo Comparator
Arm Description
Fluoride Free
Arm Title
ProClude Prophylaxis paste
Arm Type
Experimental
Arm Description
Arginine
Intervention Type
Device
Intervention Name(s)
Arginine/Calcium Carbonate
Intervention Description
One application
Intervention Type
Device
Intervention Name(s)
Mint Prophy paste - Fluoride free
Other Intervention Name(s)
Nupro C Prophylaxis paste - Fluoride free
Intervention Description
one application
Primary Outcome Measure Information:
Title
Tooth Hypersensitity to Touch Stimuli (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 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
Time Frame
12 weeks (Final)
Title
Tooth Hypersensivity Stimuli to Air
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
12 weeks (Final)

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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Schiff, DMD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobsen Dental Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction

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