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Trial record 4 of 43 for:    FLUORIDE ION AND TRICLOSAN

Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

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ClinicalTrials.gov Identifier: NCT00762853
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : September 14, 2010
Last Update Posted : February 17, 2012
Sponsor:
Information provided by:
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dental Plaque
Interventions Drug: Fluoride
Drug: Fluoride and triclosan
Enrollment 20
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 began a 1 week washout period with fluoride toothpaste.
Arm/Group Title Placebo First, Active Second Active Toothpaste First, Then Placebo
Hide Arm/Group Description subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention. Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
Period Title: First Treatment Period
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: 1 Week Washout After Treatment 1
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Second Treatment Period
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Placebo First, Active Second Active Toothpaste First, Then Placebo Total
Hide Arm/Group Description subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention. Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
35.9  (11.9) 35.6  (9.9) 35.8  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
5
  50.0%
5
  50.0%
10
  50.0%
Male
5
  50.0%
5
  50.0%
10
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Triclosan Concentration in Dental Plaque
Hide Description Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.
Time Frame 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoride Toothpaste (Placebo) Active Toothpaste
Hide Arm/Group Description:
fluoride only toothpaste
fluoride/triclosan/copolymer(Active) toothpaste
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: ppm levels of triclosan
0  (0) 1.8  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoride Toothpaste (Placebo), Active 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 16 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo First, Active Second Active Toothpaste First, Then Placebo
Hide Arm/Group Description subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention. Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
All-Cause Mortality
Placebo First, Active Second Active Toothpaste First, Then Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo First, Active Second Active Toothpaste First, Then Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo First, Active Second Active Toothpaste First, Then Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (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: NCT00762853     History of Changes
Other Study ID Numbers: CRO-2008-PLA-16-RR
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: August 19, 2010
Results First Posted: September 14, 2010
Last Update Posted: February 17, 2012