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Trial record 24 of 43 for:    FLUORIDE ION AND TRICLOSAN

The Efficacy of a Toothpaste to Reduce Sensitivity

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: NCT00763269
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : September 17, 2010
Last Update Posted : March 7, 2012
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dentin Hypersensitivity
Interventions Drug: Triclosan, Silicon dioxide, fluoride
Drug: Triclosan, fluoride
Enrollment 626
Recruitment Details subjects were recruited by the PI at the clinical site
Pre-assignment Details subjects were screened for medical and oral health criteria and then entered a 1 week washout before study treatment period.
Arm/Group Title A-Experimental Toothpatse B -Control Toothpaste
Hide Arm/Group Description fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula) Fluoride/Triclosan control toothpaste
Period Title: Overall Study
Started 314 312
Completed 302 299
Not Completed 12 13
Reason Not Completed
Lost to Follow-up             12             13
Arm/Group Title A-Experimental Toothpatse B -Control Toothpaste Total
Hide Arm/Group Description fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula) Fluoride/Triclosan control toothpaste Total of all reporting groups
Overall Number of Baseline Participants 314 312 626
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 312 participants 626 participants
<=18 years
7
   2.2%
2
   0.6%
9
   1.4%
Between 18 and 65 years
301
  95.9%
306
  98.1%
607
  97.0%
>=65 years
6
   1.9%
4
   1.3%
10
   1.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 314 participants 312 participants 626 participants
40.6  (13.4) 41.4  (12.1) 41  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants 312 participants 626 participants
Female
226
  72.0%
233
  74.7%
459
  73.3%
Male
88
  28.0%
79
  25.3%
167
  26.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 314 participants 312 participants 626 participants
314 312 626
1.Primary Outcome
Title Hypersensitivity Tactile(Yeaple Probe)
Hide Description Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A-Experimental Toothpatse B -Control Toothpaste
Hide Arm/Group Description:
fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
Fluoride/Triclosan control toothpaste
Overall Number of Participants Analyzed 314 312
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.81  (9.56) 13.94  (6.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Experimental Toothpatse, B -Control Toothpaste
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Hypersensitivity Tactile (Yeaple Probe)
Hide Description Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A-Experimental Toothpatse B -Control Toothpaste
Hide Arm/Group Description:
fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
Fluoride/Triclosan control toothpaste
Overall Number of Participants Analyzed 314 312
Mean (Standard Deviation)
Unit of Measure: Units on a scale
31.90  (12.26) 17.28  (8.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Experimental Toothpatse, B -Control Toothpaste
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Air Blast Hypersensitivity (4 Week)
Hide Description Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:“0”No subject response to stimulus“1”responds but will continue“2”responds and moves or requests discontinuation“3”Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A-Experimental Toothpatse B -Control Toothpaste
Hide Arm/Group Description:
fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
Fluoride/Triclosan control toothpaste
Overall Number of Participants Analyzed 314 312
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.61  (0.62) 2.18  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Experimental Toothpatse, B -Control Toothpaste
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Air Blast Hypersensitivity (8 Week)
Hide Description Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"0"No subject response to stimulus"1"responds but will continue"2"responds and moves or requests discontinuation"3"Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A-Experimental Toothpatse B -Control Toothpaste
Hide Arm/Group Description:
fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
Fluoride/Triclosan control toothpaste
Overall Number of Participants Analyzed 314 312
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.89  (0.69) 1.80  (0.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A-Experimental Toothpatse, B -Control Toothpaste
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A-Experimental Toothpatse B -Control Toothpaste
Hide Arm/Group Description fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula) Fluoride/Triclosan control toothpaste
All-Cause Mortality
A-Experimental Toothpatse B -Control Toothpaste
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
A-Experimental Toothpatse B -Control Toothpaste
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/314 (0.00%)      0/312 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A-Experimental Toothpatse B -Control Toothpaste
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/314 (0.96%)      4/312 (1.28%)    
General disorders     
Burning sensation of mucosa * [1]  1/314 (0.32%)  1 1/312 (0.32%)  1
Redness in Perioral area (possible allergic reaction) * [2]  1/314 (0.32%)  1 0/312 (0.00%)  0
Physical Accidents w/ injuries * [3]  1/314 (0.32%)  1 3/312 (0.96%)  4
*
Indicates events were collected by non-systematic assessment
[1]
subject reported burning sensation on tongue, cheeks and lips. subject discontinued during the 4 weeks visit.
[2]
subject observed redness in perioral area. visited dermatologist who diagnosed a possible allergic reaction and recommended to discontinue study toothpaste.
[3]
Several subjects reported accident. 1 had a workplace accident and was put on bedrest. 1 fell and broke wrist while walking.1 fell in backyard and broke a bone in left foot. adn 1 subject reported 2 events(a foot sprain and a broken left foot bone.
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: William De Vizio
Organization: Colgate Palmolive Co.
Phone: 732-878-7901
EMail: William_Devizio@colpal.com
Layout table for additonal information
Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00763269     History of Changes
Other Study ID Numbers: CRO-0208-TOT-SEN-PR
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: August 24, 2010
Results First Posted: September 17, 2010
Last Update Posted: March 7, 2012