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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 20, 2014
Last verified: August 2014
  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: Group C
Device: Group A
Device: Group B

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:
  • Baseline Pre-Prophy Assessment (Tactile Sensitivity) [ Time Frame: Pre-treatment measurement ] [ Designated as safety issue: No ]

    Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv

    Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.


  • Immediate Sensitivity Relief (Tactile Sensitivity) [ Time Frame: Immediately after treatment . ] [ Designated as safety issue: No ]

    Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.

    Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.


  • Long-term Sensitivity Relief (Tactile Sensitivity) [ Time Frame: 28 days (+/- 2 days) post treatment. ] [ Designated as safety issue: No ]

    Assessment of sensitivity score via tactile measurements long term after treatment.

    Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.

    Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.


  • Baseline Pre-Prophy Assessment (Air Blast Sensitivity) [ Time Frame: Pre-treatment measurement ] [ Designated as safety issue: No ]

    Pre-prophy procedure baseline assessment using Schiff Cold Air Sensitivity scale (0-3).

    Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivty scale (0-3). The scale is scored as follows:

    0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.

    The higher the score, the higher the hypersensitivity.

    Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.


  • Immediate Sensitivity Relief (Schiff Air Blast Sensitivity) [ Time Frame: Immediately after treatment . ] [ Designated as safety issue: No ]

    Assessment of sensitivity score via air blast measurements immediately after treatment.

    Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:

    0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.

    Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.


  • Long-term Sensitivity Relief (Schiff Air Blast Sensitivity) [ Time Frame: 28 days (+/- 2 days) post treatment. ] [ Designated as safety issue: No ]

    Assessment of sensitivity score Schiff air blast measurements long term after treatment.

    Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:

    0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.

    Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.



Secondary Outcome Measures:
  • Sensitivity Relief (Self-Assessment) [ Time Frame: Pre-Treatment ] [ Designated as safety issue: No ]

    All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity prior to the baseline assessments.

    The questionnaire contained a 4-item verbal descriptor scale as follows:

    Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.

    The higher the score, the higher the hypersensitivity.

    Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.


  • Post- Scaling Sensitivity Relief (Self-Assessment) [ Time Frame: Post-scaling procedure,immediate ] [ Designated as safety issue: No ]

    All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity immediately following the scaling procedure.

    The questionnaire contained a 4-item verbal descriptor scale as follows:

    Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.

    The higher the score, the higher the hypersensitivity.

    Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.


  • Post-prophylaxis Sensitivity Relief (Self-Assessment) [ Time Frame: Immediately following post-prophylaxis treatment. ] [ Designated as safety issue: No ]

    All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity immediately following the timed, 1-minute prophylaxis paste application.

    The questionnaire contained a 4-item verbal descriptor scale as follows:

    Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth;2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.

    The higher the score, the higher the hypersensitivity.

    Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.


  • Long-term Sensitivity Relief (Self-Assessment) [ Time Frame: 28 days post-prophylaxis treatment. ] [ Designated as safety issue: No ]

    All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity 28 days following prophylaxis treatment.

    The questionnaire contained a 4-item verbal descriptor scale as follows:

    Score 0= no discomfort or awareness of sensitivity;1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.

    The higher the score, the higher the hypersensitivity.

    Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.



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: Group C

NUPRO Classic Prophy Paste

Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..

Leave in contact for 60 seconds, rinse with water and expectorate.

Device: Group C
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Other Name: NUPRO Classic Prophy Paste
Experimental: Group A

NUPRO Sensodyne Prophy Paste w/ Novamin

Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.

Leave in contact for 60 seconds, rinse with water and expectorate

Device: Group B
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Other Name: NUPRO Sensodyne Prophy Paste with NovaMin without Fluoride.
Experimental: Group B

NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride

Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.

Leave in contact for 60 seconds, rinse with water and expectorate.

Device: Group A
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Other Name: NUPRO Sensodyne Prophy Paste with NovaMin with Fluoride.

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
Investigators
Principal Investigator: Jeffrey L Milleman, DDS, MPA Salus Research
  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
Results First Received: February 20, 2014
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014