Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste

Colgate-Palmolive

Status and phase

Completed

Phase 3

Conditions

Hypersensitivity

Treatments

Device: Nupro - Fluoride Free

Device: Arginine/Calcium Carbonate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01072188

CRO-2008-07-SEN-PROPREC-ED

Details and patient eligibility

About

The objective of this study is to evaluate the clinical efficacy of a prophylaxis paste containing 10% arginine bicarbonate on dentinal hypersensitivity reduction when applied as a pre-procedure to a professional dental cleaning.

Enrollment

45 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male and female subjects, ages 18-70, inclusive.
Availability for the three (3) week duration of the study.
Two (2) 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.
Scheduled dental prophylaxis within three weeks prior to the Baseline Hypersensitivity Examination.
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.