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Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction

NCT ID: NCT01040169

Last Updated: 2013-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-08-31

Brief Summary

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Tooth sensitivity reduction after dentifrices use

Detailed Description

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Conditions

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Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nupro C Prophylaxis paste

Fluoride Free

Group Type PLACEBO_COMPARATOR

Mint Prophy paste - Fluoride free

Intervention Type DEVICE

one application

ProClude Prophylaxis paste

Arginine

Group Type EXPERIMENTAL

Arginine/Calcium Carbonate

Intervention Type DEVICE

One application

Interventions

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Arginine/Calcium Carbonate

One application

Intervention Type DEVICE

Mint Prophy paste - Fluoride free

one application

Intervention Type DEVICE

Other Intervention Names

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Nupro C Prophylaxis paste - Fluoride free

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Schiff, DMD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Jacobsen Dental Clinic

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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CRO-0308-SF-PROC-SEN-ED

Identifier Type: -

Identifier Source: org_study_id