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

Primary Purpose

Tooth Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NUPRO Classic Prophy Paste
NUPRO Sensodyne Prophy Paste with Novamin with fluoride.
NUPRO Sensodyne Prophy Paste with Novamin without fluoride.
Sponsored by
Dentsply International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Hypersensitivity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Salus Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

NUPRO(r) Classic Prophy Paste

NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ fluoride.

NUPRO Sensodyne Prophy Paste w/ Novamin

Arm Description

Outcomes

Primary Outcome Measures

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.
Adverse Events.
Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 30, 2012
Last Updated
August 8, 2013
Sponsor
Dentsply International
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1. Study Identification

Unique Protocol Identification Number
NCT01610167
Brief Title
NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r)Sensitivity Relief Study
Official Title
NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r) for the Treatment of Dentin Hypersensitivity.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dentsply International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NUPRO(r) Classic Prophy Paste
Arm Type
Active Comparator
Arm Title
NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ fluoride.
Arm Type
Experimental
Arm Title
NUPRO Sensodyne Prophy Paste w/ Novamin
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
NUPRO Classic Prophy Paste
Intervention Description
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Intervention Type
Device
Intervention Name(s)
NUPRO Sensodyne Prophy Paste with Novamin with fluoride.
Intervention Description
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Intervention Type
Device
Intervention Name(s)
NUPRO Sensodyne Prophy Paste with Novamin without fluoride.
Intervention Description
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Primary Outcome Measure Information:
Title
Immediate Sensitivity Relief. Tactile Sensitivity.
Description
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.
Time Frame
Immediately after treatment.
Title
Adverse Events.
Description
Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).
Time Frame
Immediately after treatment to 28 days (+/- 2 days) post treatment.
Title
Immediate Sensitivity Relief. Air Blast Sensitivity.
Description
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.
Time Frame
Immediately after treatment.
Secondary Outcome Measure Information:
Title
Extended Sensitivity Relief. Tactile Sensitivity.
Description
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.
Time Frame
28 days (+/- 2 days) post treatment.
Title
Extended Sensitivity Relief. Air Blast Sensitivity.
Description
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.
Time Frame
28 days (+/- 2 days) post treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery L. Milleman, DDS, MPA
Organizational Affiliation
Salus Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kimberly R. Milleman, ASDH, MS
Organizational Affiliation
Salus Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salus Research
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States

12. IPD Sharing Statement

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

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