The Efficacy of a Toothpaste to Reduce Sensitivity

NCT00763269 | Completed Phase 3 Results

• 1 other identifier: CRO-0208-TOT-SEN-PR
• Study Type: interventional
• Target: 626
• Locations: 1 country
• Sites: 1

Brief Summary

Hypersensitivity

Conditions

Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Air Blast Hypersensitivity (4 Week)

  4 weeks

• Air Blast Hypersensitivity (8 Week)

  8 weeks

Study Arms (2)

A

EXPERIMENTAL

sensitive toothpaste

Drug: Triclosan, Silicon dioxide, fluoride

B

ACTIVE COMPARATOR

Triclosan control toothpaste

Drug: Triclosan, fluoride

Interventions

Triclosan, Silicon dioxide, fluoride DRUG

Brush twice daily

A

Triclosan, fluoride DRUG

Brush twice daily

B

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Concordia Clinical Research

Cedar Knolls, New Jersey, 08225, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Triclosan; Silicon Dioxide; Fluorides

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Minerals; Inorganic Chemicals; Oxides; Oxygen Compounds; Silicon Compounds; Anions; Ions; Electrolytes; Hydrofluoric Acid; Fluorine Compounds

Results Point of Contact

• Title: William De Vizio
• Organization: Colgate Palmolive Co.

William_Devizio@colpal.com

732-878-7901

Study Officials

• Augusto Elias, DDS

  Univ of Puerto Rico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 7, 2012
• Results First Posted: September 17, 2010

Record last verified: 2011-06

Locations

US (1)