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

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

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.

Study Overview

• Status: Completed
• Conditions: Tooth Hypersensitivity
• Intervention / Treatment: Device: NUPRO Classic Prophy Paste; Device: NUPRO Sensodyne Prophy Paste with Novamin with fluoride.; Device: NUPRO Sensodyne Prophy Paste with Novamin without fluoride.

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.

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Salus Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NUPRO(r) Classic Prophy Paste	Device: NUPRO Classic Prophy Paste; Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Experimental: NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ fluoride.	Device: NUPRO Sensodyne Prophy Paste with Novamin with fluoride.; Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Experimental: NUPRO Sensodyne Prophy Paste w/ Novamin	Device: NUPRO Sensodyne Prophy Paste with Novamin without fluoride.; Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Dentsply International
• Investigators: Principal Investigator: Jeffery L. Milleman, DDS, MPA, Salus Research; Principal Investigator: Kimberly R. Milleman, ASDH, MS, Salus Research

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: May 30, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (Estimate): June 1, 2012

Study Record Updates

• Last Update Posted (Estimate): October 14, 2013
• Last Update Submitted That Met QC Criteria: August 8, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: CTP-001