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Trial record 23 of 43 for:    FLUORIDE ION AND TRICLOSAN

Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes

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: NCT00762515
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : December 14, 2010
Last Update Posted : December 28, 2010
Sponsor:
Information provided by:
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dental Plaque
Interventions Drug: Fluoride
Drug: Triclosan
Enrollment 44
Recruitment Details subjects recruited by the PI at the clinical site.
Pre-assignment Details Screening for subjects that met the overall oral health criteria. Followed by a 1 week washout prior to starting any study treatments or procedures.
Arm/Group Title A -Placebo Comparator B- Active Comparator
Hide Arm/Group Description Fluoride toothpaste Fluoride/triclosan toothpaste (Total)
Period Title: Overall Study
Started 22 22
Completed 22 22
Not Completed 0 0
Arm/Group Title A -Placebo Comparator B- Active Comparator Total
Hide Arm/Group Description Fluoride toothpaste Fluoride/triclosan toothpaste (Total) Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
22
 100.0%
44
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
15
  68.2%
13
  59.1%
28
  63.6%
Male
7
  31.8%
9
  40.9%
16
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 44 participants
22 22 44
1.Primary Outcome
Title Control Established Plaque in Adults
Hide Description Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A -Placebo Comparator B- Active Comparator
Hide Arm/Group Description:
Fluoride toothpaste
Fluoride/triclosan toothpaste (Total)
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.42  (0.47) 2.45  (0.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A -Placebo Comparator, B- Active Comparator
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 baseline is used a factor
2.Secondary Outcome
Title Control Gingivitis in Adults
Hide Description Gingivitis Index (GI) is described as Units on a scale 0 to 3 (0 = no inflammation,1 = Mild inflammation - slight change in color and little change in texture 2 = Moderate inflammation - moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI score = Sum of all scores divided by the number of sites (teeth scored).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A -Placebo Comparator B- Active Comparator
Hide Arm/Group Description:
Fluoride toothpaste
Fluoride/triclosan toothpaste (Total)
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.54  (0.16) 0.63  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A -Placebo Comparator, B- Active Comparator
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 baseline to be used a factor
Time Frame 7 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A -Placebo Comparator B- Active Comparator
Hide Arm/Group Description Fluoride toothpaste Fluoride/triclosan toothpaste (Total)
All-Cause Mortality
A -Placebo Comparator B- Active Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A -Placebo Comparator B- Active Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (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 -Placebo Comparator B- Active Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (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: William Devizio
Organization: Colgate Palmolive Co.
Phone: 732-878-7901
EMail: William_Devizio@colpal.com
Layout table for additonal information
Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00762515     History of Changes
Other Study ID Numbers: CRO-2007-GIN-03-RR
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: August 19, 2010
Results First Posted: December 14, 2010
Last Update Posted: December 28, 2010