NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply International
ClinicalTrials.gov Identifier:
NCT01669785
First received: June 8, 2012
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

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 Intervention
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.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: NUPRO Sensodyne Prophylaxis Paste With NovaMin for the Treatment of Dentin Hypersensitivity.

Resource links provided by NLM:


Further study details as provided by Dentsply International:

Primary Outcome Measures:
  • Immediate sensitivity relief. [ Time Frame: 10-20 minutes after initial application ] [ Designated as safety issue: No ]
    Assessment of sensitivity score via tactile and air blast measurements immediately after treatment.

  • Immediate assessment of adverse reaction to prophylaxis paste. [ Time Frame: 10 - 20 minutes after initial application. ] [ Designated as safety issue: Yes ]
    Assessment of adverse events that may occur asa result of treatment (typically includes any kind of allergic reaction).

  • Assessment of adverse reaction to prophylaxis paste. [ Time Frame: 28 days (+/- 2 days) post treatment. ] [ Designated as safety issue: Yes ]
    Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reaction to paste).


Secondary Outcome Measures:
  • Sensitivity relief. [ Time Frame: 28 days post treatment. ] [ Designated as safety issue: No ]

    Assess the sensitivity score via tactile and air measurements approximately 28 days post treatment.

    Assess the results of the sensitivity questionnaire.



Enrollment: 139
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NUPRO 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 Device: NUPRO Sensodyne Prophy Paste with NovaMin without Fluoride.
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Experimental: NUPRO Sensodyne Prophy Paste w/ NovaMin w/ Fluoride. Device: NUPRO Sensodyne Prophy Paste with NovaMin with Fluoride.
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Availability to complete in the 28 day duration.
  • Two sensitive teeth, which are not adjacent to each other and preferably in different quadrants, which 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.
  • Subjects need to satisfy the qualifying response to stimuli for both parameters assesses (Tactile or Air Blast) on at least two teeth (non-adjacent) to be entered into the study.
  • Good general health with no known allergies to products being tested.
  • Use of a non-desensitizing dentifrice for 2 weeks prior to entry into the study.
  • Subjects must have a minimum of 10 natural 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 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; b0 A member or relative of teh study site staff directly involved with the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669785

Locations
United States, Indiana
Salus Research, Inc.
Fort Wayne,, Indiana, United States, 46825
Sponsors and Collaborators
Dentsply International
  More Information

No publications provided

Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT01669785     History of Changes
Other Study ID Numbers: CTP-002
Study First Received: June 8, 2012
Last Updated: August 17, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014