Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction

NCT01040169 | Completed Results

• 1 other identifier: CRO-0308-SF-PROC-SEN-ED
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Tooth sensitivity reduction after dentifrices use

Conditions

Hypersensitivity

Outcome Measures

Primary Outcomes (2)

• 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

  12 weeks (Final)

• 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.

  12 weeks (Final)

Study Arms (2)

Nupro C Prophylaxis paste

PLACEBO COMPARATOR

Fluoride Free

Device: Mint Prophy paste - Fluoride free

ProClude Prophylaxis paste

EXPERIMENTAL

Arginine

Device: Arginine/Calcium Carbonate

Interventions

Arginine/Calcium Carbonate DEVICE

One application

ProClude Prophylaxis paste

Mint Prophy paste - Fluoride free DEVICE

one application

Also known as: Nupro C Prophylaxis paste - Fluoride free

Nupro C Prophylaxis paste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Jacobsen Dental Clinic

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: William DeVizio - DMD
• Organization: Colgate Palmolive

william_devizio@colpal.com

732-878-7901

Study Officials

• Thomas Schiff, DMD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• 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 27, 2008
• First Posted: December 29, 2009
• Study Start: May 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 10, 2013
• Results First Posted: December 29, 2009

Record last verified: 2013-11

Locations

US (1)