Back to resultsNUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study
Primary Purpose
Tooth Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group C
Group A
Group B
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Hypersensitivity
Eligibility 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.
Sites / Locations
- Salus Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Group C
Group A
Group B
Arm Description
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.
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
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.
Outcomes
Primary Outcome Measures
Baseline Pre-Prophy Assessment (Tactile Sensitivity)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01669785
Brief Title
NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study
Official Title
NUPRO Sensodyne Prophylaxis Paste With NovaMin for the Treatment of Dentin Hypersensitivity.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (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 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
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group A
Arm Type
Experimental
Arm Description
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
Arm Title
Group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Group C
Other 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)
Group A
Other 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)
Group B
Other 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
Baseline Pre-Prophy Assessment (Tactile Sensitivity)
Description
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.
Time Frame
Pre-treatment measurement
Title
Immediate Sensitivity Relief (Tactile Sensitivity)
Description
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.
Time Frame
Immediately after treatment .
Title
Long-term Sensitivity Relief (Tactile Sensitivity)
Description
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.
Time Frame
28 days (+/- 2 days) post treatment.
Title
Baseline Pre-Prophy Assessment (Air Blast Sensitivity)
Description
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.
Time Frame
Pre-treatment measurement
Title
Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)
Description
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.
Time Frame
Immediately after treatment .
Title
Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)
Description
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.
Time Frame
28 days (+/- 2 days) post treatment.
Secondary Outcome Measure Information:
Title
Sensitivity Relief (Self-Assessment)
Description
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.
Time Frame
Pre-Treatment
Title
Post- Scaling Sensitivity Relief (Self-Assessment)
Description
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.
Time Frame
Post-scaling procedure,immediate
Title
Post-prophylaxis Sensitivity Relief (Self-Assessment)
Description
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.
Time Frame
Immediately following post-prophylaxis treatment.
Title
Long-term Sensitivity Relief (Self-Assessment)
Description
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.
Time Frame
28 days post-prophylaxis 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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Milleman, DDS, MPA
Organizational Affiliation
Salus Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salus Research, Inc.
City
Fort Wayne,
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
12. IPD Sharing Statement
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NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study
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