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The Efficacy of a Toothpaste to Reduce Sensitivity

Primary Purpose

Dentin Hypersensitivity

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Triclosan, Silicon dioxide, fluoride
Triclosan, fluoride
Sponsored by
Colgate Palmolive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male and female subjects, ages: 12 years or older.
  • Availability for the eight-week 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 10-50 grams 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 parameters assessed (Tactile or Air Blast) on at least 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 one month 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 a 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.
  • Regular use of anticonvulsants, antihistamines, sedatives, tranquilizers, anti-inflammatory drugs, or analgesics.
  • Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past one month.
  • Current participation in any other clinical study.
  • Allergies to triclosan, or oral care products, personal care consumer products, or their ingredients.
  • Medical condition which prohibits not eating/drinking for 4 hours.

Sites / Locations

  • Concordia Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

sensitive toothpaste

Triclosan control toothpaste

Outcomes

Primary Outcome Measures

Hypersensitivity Tactile(Yeaple Probe)
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. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth
Hypersensitivity Tactile (Yeaple Probe)
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. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth

Secondary Outcome Measures

Air Blast Hypersensitivity (4 Week)
Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"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. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.
Air Blast Hypersensitivity (8 Week)
Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"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. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.

Full Information

First Posted
September 26, 2008
Last Updated
March 5, 2012
Sponsor
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT00763269
Brief Title
The Efficacy of a Toothpaste to Reduce Sensitivity
Official Title
The Efficacy of a Toothpaste to Reduce Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 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
Hypersensitivity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
626 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
sensitive toothpaste
Arm Title
B
Arm Type
Active Comparator
Arm Description
Triclosan control toothpaste
Intervention Type
Drug
Intervention Name(s)
Triclosan, Silicon dioxide, fluoride
Intervention Description
Brush twice daily
Intervention Type
Drug
Intervention Name(s)
Triclosan, fluoride
Intervention Description
Brush twice daily
Primary Outcome Measure Information:
Title
Hypersensitivity Tactile(Yeaple Probe)
Description
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. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth
Time Frame
4 weeks
Title
Hypersensitivity Tactile (Yeaple Probe)
Description
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. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Air Blast Hypersensitivity (4 Week)
Description
Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"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. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.
Time Frame
4 weeks
Title
Air Blast Hypersensitivity (8 Week)
Description
Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"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. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female subjects, ages: 12 years or older. Availability for the eight-week 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 10-50 grams 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 parameters assessed (Tactile or Air Blast) on at least 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 one month 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 a 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. Regular use of anticonvulsants, antihistamines, sedatives, tranquilizers, anti-inflammatory drugs, or analgesics. Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past one month. Current participation in any other clinical study. Allergies to triclosan, or 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
Augusto Elias, DDS
Organizational Affiliation
Univ of Puerto Rico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Concordia Clinical Research
City
Cedar Knolls
State/Province
New Jersey
ZIP/Postal Code
08225
Country
United States

12. IPD Sharing Statement

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The Efficacy of a Toothpaste to Reduce Sensitivity

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