The Efficacy of a Toothpaste to Reduce Sensitivity

Dentin Hypersensitivity Clinical Trial

Official title:

The Efficacy of a Toothpaste to Reduce Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763269
• Other study ID #: CRO-0208-TOT-SEN-PR
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: March 5, 2012
• Start date: September 2008
• Est. completion date: December 2008

Study information

• Verified date: June 2011
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Hypersensitivity

Recruitment information / eligibility

• Status: Completed
• Enrollment: 626
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

Drug:
• Triclosan, Silicon dioxide, fluoride
Brush twice daily
• Triclosan, fluoride
Brush twice daily

Locations

Country	Name	City	State
United States	Concordia Clinical Research	Cedar Knolls	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks	No
Primary	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	8 weeks	No
Secondary	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.	4 weeks	No
Secondary	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.	8 weeks	No