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Trial record 34 of 292 for:    Sodium Fluoride OR Duraphat

NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01669785
Recruitment Status : Completed
First Posted : August 21, 2012
Results First Posted : August 21, 2014
Last Update Posted : August 21, 2014
Sponsor:
Information provided by (Responsible Party):
Dentsply International

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Tooth Hypersensitivity
Interventions Device: Group C
Device: Group A
Device: Group B
Enrollment 139
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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.

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.

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.

Period Title: Overall Study
Started 45 48 46
Completed 45 48 46
Not Completed 0 0 0
Arm/Group Title Group A Group B Group C Total
Hide Arm/Group 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.

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.

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. Total of all reporting groups
Overall Number of Baseline Participants 45 48 46 139
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Mean years of age
Number Analyzed 45 participants 48 participants 46 participants 139 participants
44  (11.18274) 41  (11.21829) 43  (10.928) 43  (11.10967)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 48 participants 46 participants 139 participants
Female
36
  80.0%
39
  81.3%
35
  76.1%
110
  79.1%
Male
9
  20.0%
9
  18.8%
11
  23.9%
29
  20.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 48 participants 46 participants 139 participants
45 48 46 139
1.Primary Outcome
Title Baseline Pre-Prophy Assessment (Tactile Sensitivity)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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.

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.

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.

Overall Number of Participants Analyzed 45 48 46
Mean (Standard Deviation)
Unit of Measure: grams
10.56  (1.59) 10.00  (0.00) 10.98  (2.27)
2.Primary Outcome
Title Immediate Sensitivity Relief (Tactile Sensitivity)
Hide 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 .
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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.

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.

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.

Overall Number of Participants Analyzed 45 48 46
Mean (Standard Deviation)
Unit of Measure: grams
19.61  (11.31) 16.67  (9.01) 12.01  (5.52)
3.Primary Outcome
Title Long-term Sensitivity Relief (Tactile Sensitivity)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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.

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.

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.

Overall Number of Participants Analyzed 45 48 46
Mean (Standard Deviation)
Unit of Measure: grams
19.89  (11.46) 16.51  (10.35) 12.07  (5.20)
4.Primary Outcome
Title Baseline Pre-Prophy Assessment (Air Blast Sensitivity)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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.

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.

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.

Overall Number of Participants Analyzed 45 48 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.72  (0.58) 1.70  (0.58) 1.65  (0.60)
5.Primary Outcome
Title Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)
Hide 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 .
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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.

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.

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.

Overall Number of Participants Analyzed 45 48 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.88  (0.64) 0.97  (0.52) 1.72  (0.70)
6.Primary Outcome
Title Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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.

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.

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.

Overall Number of Participants Analyzed 45 48 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.87  (0.63) 1.11  (0.61) 1.67  (0.67)
7.Secondary Outcome
Title Sensitivity Relief (Self-Assessment)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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.

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.

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.

Overall Number of Participants Analyzed 45 48 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.82  (0.72) 0.67  (0.75) 0.76  (0.74)
8.Secondary Outcome
Title Post- Scaling Sensitivity Relief (Self-Assessment)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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.

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.

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.

Overall Number of Participants Analyzed 45 48 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.31  (0.79) 0.98  (0.67) 1.28  (0.72)
9.Secondary Outcome
Title Post-prophylaxis Sensitivity Relief (Self-Assessment)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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.

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.

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.

Overall Number of Participants Analyzed 45 48 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.00  (0.90) 0.90  (0.81) 1.09  (0.69)
10.Secondary Outcome
Title Long-term Sensitivity Relief (Self-Assessment)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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.

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.

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.

Overall Number of Participants Analyzed 45 48 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.60  (0.62) 0.50  (0.71) 0.72  (0.69)
Time Frame Patients were monitored for adverse events during intraoral examinations performed after paste application and 28 days following paste application.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Group B Group C
Hide Arm/Group 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.

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.

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.

All-Cause Mortality
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/48 (0.00%)   0/46 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/48 (0.00%)   0/46 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffery L. Milleman, DDS, MPA
Organization: Salus Research, Inc.
Phone: 260-755-1099
Layout table for additonal information
Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT01669785     History of Changes
Other Study ID Numbers: CTP-002
First Submitted: June 8, 2012
First Posted: August 21, 2012
Results First Submitted: February 20, 2014
Results First Posted: August 21, 2014
Last Update Posted: August 21, 2014