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

Tooth Hypersensitivity Clinical Trial

Official title:

NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r) for the Treatment of Dentin Hypersensitivity.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610167
• Other study ID #: CTP-001
• Status: Completed
• Phase: N/A
• First received: May 30, 2012
• Last updated: August 8, 2013
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: August 2013
• Source: Dentsply International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Tooth Hypersensitivity

Intervention

Device:
• NUPRO Classic Prophy Paste
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
• NUPRO Sensodyne Prophy Paste with Novamin with fluoride.
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
• NUPRO Sensodyne Prophy Paste with Novamin without fluoride.
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.

Locations

Country	Name	City	State
United States	Salus Research	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate Sensitivity Relief. Tactile Sensitivity.	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.	Immediately after treatment.	No
Primary	Adverse Events.	Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).	Immediately after treatment to 28 days (+/- 2 days) post treatment.	Yes
Primary	Immediate Sensitivity Relief. Air Blast Sensitivity.	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.	Immediately after treatment.	No
Secondary	Extended Sensitivity Relief. Tactile Sensitivity.	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.	28 days (+/- 2 days) post treatment.	No
Secondary	Extended Sensitivity Relief. Air Blast Sensitivity.	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.	28 days (+/- 2 days) post treatment.	No