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Trial record 24 of 292 for:    Sodium Fluoride OR Duraphat

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

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ClinicalTrials.gov Identifier: NCT01610167
Recruitment Status : Completed
First Posted : June 1, 2012
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2013
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: NUPRO Classic Prophy Paste
Device: NUPRO Sensodyne Prophy Paste with Novamin with fluoride.
Device: NUPRO Sensodyne Prophy Paste with Novamin without fluoride.
Enrollment 151
Recruitment Details 327 subjects queried from Investigator database following IRB apprvoal on 14-Sept.-2011. 199 of the queried subjects were consented and screened. 161 subjects were accepted at screening and appointed for baseline visit 2 weeks later. 159 subjects were evaluated at the baseline exam and 151 subjects were randomized and enrolled into the study.
Pre-assignment Details 10 subjects were lost following screening and at baseline assessment. 5 of the 10 were disqualified due to insufficient tactile response, 3 due to lack of evaproative hypersensitivity, and 2 had scheduling conflicts.
Arm/Group Title NUPRO Sensodyne Prophy Paste w/ Novamin NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. NUPRO(r) Classic Prophy Paste
Hide Arm/Group Description NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Period Title: Overall Study
Started 52 49 50
Completed 52 49 48
Not Completed 0 0 2
Reason Not Completed
Scheduling conflict.             0             0             2
Arm/Group Title NUPRO Sensodyne Prophy Paste w/ Novamin NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. NUPRO(r) Classic Prophy Paste Total
Hide Arm/Group Description NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. Total of all reporting groups
Overall Number of Baseline Participants 52 49 50 151
Hide Baseline Analysis Population Description
Intent to treat (ITT).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 49 participants 50 participants 151 participants
<=18 years
0
   0.0%
0
   0.0%
1
   2.0%
1
   0.7%
Between 18 and 65 years
52
 100.0%
49
 100.0%
49
  98.0%
150
  99.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 49 participants 50 participants 151 participants
41.31  (11.10) 41.55  (10.70) 42.10  (10.31) 41.65  (10.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 49 participants 50 participants 151 participants
Female
37
  71.2%
35
  71.4%
35
  70.0%
107
  70.9%
Male
15
  28.8%
14
  28.6%
15
  30.0%
44
  29.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants 49 participants 50 participants 151 participants
52 49 50 151
1.Primary Outcome
Title Immediate Sensitivity Relief. Tactile Sensitivity.
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT).
Arm/Group Title NUPRO Sensodyne Prophy Paste w/ Novamin NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. NUPRO(r) Classic Prophy Paste
Hide Arm/Group Description:
NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Overall Number of Participants Analyzed 52 49 50
Mean (Standard Deviation)
Unit of Measure: grams
12.36  (12.91) 10.46  (12.58) 0.60  (3.45)
2.Primary Outcome
Title Adverse Events.
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT).
Arm/Group Title NUPRO Sensodyne Prophy Paste w/ Novamin NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. NUPRO(r) Classic Prophy Paste
Hide Arm/Group Description:
NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Overall Number of Participants Analyzed 52 49 50
Measure Type: Number
Unit of Measure: Number of adverse events.
0 0 0
3.Primary Outcome
Title Immediate Sensitivity Relief. Air Blast Sensitivity.
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NUPRO Sensodyne Prophy Paste w/ Novamin NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. NUPRO(r) Classic Prophy Paste
Hide Arm/Group Description:
NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Overall Number of Participants Analyzed 52 49 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.87  (0.71) -0.86  (0.62) 0.00  (0.35)
4.Secondary Outcome
Title Extended Sensitivity Relief. Tactile Sensitivity.
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT).
Arm/Group Title NUPRO Sensodyne Prophy Paste w/ Novamin NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. NUPRO(r) Classic Prophy Paste
Hide Arm/Group Description:
NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Overall Number of Participants Analyzed 52 49 48
Mean (Standard Deviation)
Unit of Measure: grams
10.19  (11.37) 11.07  (11.90) 1.15  (5.88)
5.Secondary Outcome
Title Extended Sensitivity Relief. Air Blast Sensitivity.
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NUPRO Sensodyne Prophy Paste w/ Novamin NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. NUPRO(r) Classic Prophy Paste
Hide Arm/Group Description:
NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Overall Number of Participants Analyzed 52 49 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.94  (0.68) -0.95  (0.66) 0.03  (0.47)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NUPRO Sensodyne Prophy Paste w/ Novamin NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. NUPRO(r) Classic Prophy Paste
Hide Arm/Group Description NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
All-Cause Mortality
NUPRO Sensodyne Prophy Paste w/ Novamin NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. NUPRO(r) Classic Prophy Paste
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
NUPRO Sensodyne Prophy Paste w/ Novamin NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. NUPRO(r) Classic Prophy Paste
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/49 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NUPRO Sensodyne Prophy Paste w/ Novamin NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. NUPRO(r) Classic Prophy Paste
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/49 (0.00%)   0/50 (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: NCT01610167     History of Changes
Other Study ID Numbers: CTP-001
First Submitted: May 30, 2012
First Posted: June 1, 2012
Results First Submitted: February 20, 2013
Results First Posted: October 14, 2013
Last Update Posted: October 14, 2013