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

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ClinicalTrials.gov Identifier: NCT01610167
Recruitment Status : Completed
First Posted : June 1, 2012
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tooth Hypersensitivity Device: NUPRO Classic Prophy Paste Device: NUPRO Sensodyne Prophy Paste with Novamin with fluoride. Device: NUPRO Sensodyne Prophy Paste with Novamin without fluoride. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r) for the Treatment of Dentin Hypersensitivity.
Study Start Date : September 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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.




Primary Outcome Measures :
  1. Immediate Sensitivity Relief. Tactile Sensitivity. [ Time Frame: 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.

  2. Adverse Events. [ Time Frame: 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).

  3. Immediate Sensitivity Relief. Air Blast Sensitivity. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Extended Sensitivity Relief. Tactile Sensitivity. [ Time Frame: 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.

  2. Extended Sensitivity Relief. Air Blast Sensitivity. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610167


Locations
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United States, Indiana
Salus Research
Fort Wayne, Indiana, United States, 46825
Sponsors and Collaborators
Dentsply International
Investigators
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Principal Investigator: Jeffery L. Milleman, DDS, MPA Salus Research
Principal Investigator: Kimberly R. Milleman, ASDH, MS Salus Research

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Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT01610167     History of Changes
Other Study ID Numbers: CTP-001
First Posted: June 1, 2012    Key Record Dates
Results First Posted: October 14, 2013
Last Update Posted: October 14, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
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Fluorides
Sodium Fluoride
Listerine
Hypersensitivity
Dentin Sensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents