NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r)Sensitivity Relief Study

Not Applicable

Completed

Conditions: Tooth Hypersensitivity

Interventions: Device: NUPRO Sensodyne Prophy Paste with Novamin with fluoride.
Device: NUPRO Sensodyne Prophy Paste with Novamin without fluoride.
Device: NUPRO Classic Prophy Paste

Registration Number: NCT01610167

Lead Sponsor: Dentsply International

Brief Summary: The study is intended to verify through clinical measurement that the NUPRO Sensodyne Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended relief up to 28 days.

Detailed Description: It is hypothesized that the prophy paste with NovaMin(r)will give patients immediate sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 151

Inclusion Criteria

Availability to complete in the 28 day duration of the study.
Two sensitive teeth which are not adjacent to each other and preferably in different quadrants and demonstrate cervical erosion, abrasion, and gingival recession.
qualifying response to tactile stimuli as defined by a score of </= 20 grams.
Qualifying response to air blast stimuli as defined by a score of >/= 1 on the Schiff Cold Air Sensitivity Scale.
Good general health with no known allergies to products being tested.
Use of a non-desensitizing dentifrice for 3 weeks prior to entry into the study.
Able to follow study procedures and instructions.
Must have a minimum of 10 natural evaluable teeth, excluding 3rd molars.

Exclusion Criteria

Individuals who exhibit gross oral pathology
Females who may be pregnant or lactating or intending to become pregnant
Individuals who require anesthetic during scaling
Dental pathology which may cause pain similar to tooth sensitivity
Individuals with large amounts of calculus
Subjects with active infectious diseases such as hepatitis, HIV or tuberculosis
Any condition requiring antibiotic prophylaxis for dental treatment
Excessive gingival inflammation
Individuals who had their teeth cleaned within 30 days of the screening appointment
Individuals who have had a desensitizing treatment or tooth bleaching within 90 days of screening appointment.
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.
Regular use of sedatives, anti-inflammatory drugs, or analgesic
Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past 4 weeks.
Current participation in any other clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study.
Personnel; a) An employee of the sponsor; b) A member or relative of the study site staff directly involved with the study.
Allergies to oral care products, personal care consumer products, or their ingredients.
Any subject who, in the judgment of the investigator, should not participate in the study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ fluoride.	NUPRO Sensodyne Prophy Paste with Novamin with fluoride.	-
NUPRO Sensodyne Prophy Paste w/ Novamin	NUPRO Sensodyne Prophy Paste with Novamin without fluoride.	-
NUPRO(r) Classic Prophy Paste	NUPRO Classic Prophy Paste	-

Primary Outcome Measures

Name	Time	Method
Immediate Sensitivity Relief. Air Blast Sensitivity.	Immediately after treatment.	Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment.
Immediate Sensitivity Relief. Tactile Sensitivity.	Immediately after treatment.	Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a "yes" response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment.
Adverse Events.	Immediately after treatment to 28 days (+/- 2 days) post treatment.	Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).

Secondary Outcome Measures

Name	Time	Method
Extended Sensitivity Relief. Air Blast Sensitivity.	28 days (+/- 2 days) post treatment.	Assessment of cold air sensitivity. Cold air sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth.
Extended Sensitivity Relief. Tactile Sensitivity.	28 days (+/- 2 days) post treatment.	Assessment of sensitivity score via tactile stimulation 28 days post treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with "yes" response as pressure is increased in 10 gram increments. Measured sensitivity is reported as difference from baseline examination.