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Efficacy of Salivary Bacteria and Post Brushing

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ClinicalTrials.gov Identifier: NCT00981825
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : September 22, 2009
Last Update Posted : June 14, 2011
Sponsor:
Information provided by:
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Salivary Bacteria Levels
Interventions Drug: Fluoride
Drug: Triclosan/Fluoride
Enrollment 22
Recruitment Details At clinical site
Pre-assignment Details  
Arm/Group Title Fluoride 1st , Triclosan/Fluoride 2nd Triclosan/Fluoride 1st, Fluoride 2nd
Hide Arm/Group Description Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period. Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.
Period Title: First Intervention
Started 11 11
Completed 11 11
Not Completed 0 0
Period Title: Washout After 1st Intervention
Started 11 11
Completed 11 11
Not Completed 0 0
Period Title: Second Intervention
Started 11 11
Completed 11 11
Not Completed 0 0
Arm/Group Title Fluoride 1st, Triclosan/Fluoride 2nd Triclosan/Fluoride 1st, Fluoride 2nd Total
Hide Arm/Group Description Fluoride toothpaste (placebo) Triclosan/Fluoride toothpaste (experimental) Total of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
11
 100.0%
22
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 22 participants
30.8  (6.8) 30.5  (8.7) 30.6  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
7
  63.6%
7
  63.6%
14
  63.6%
Male
4
  36.4%
4
  36.4%
8
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 11 participants 11 participants 22 participants
11 11 22
1.Primary Outcome
Title CFU (Colony Forming Units)
Hide Description Total number of salivary bacterial colony forming units (lower number = less colonies present)
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoride Toothpaste (Control) Triclosan/Fluoride Toothpaste
Hide Arm/Group Description:
Fluoride toothpaste (control)
Triclosan/Fluoride toothpaste (experimental)
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: number of colony forming units
7.18  (0.61) 6.94  (0.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluoride Toothpaste (Control), Triclosan/Fluoride 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 Fluoride 1st , Triclosan/Fluoride 2nd Triclosan/Fluoride 1st, Fluoride 2nd
Hide Arm/Group Description Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period. Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.
All-Cause Mortality
Fluoride 1st , Triclosan/Fluoride 2nd Triclosan/Fluoride 1st, Fluoride 2nd
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Fluoride 1st , Triclosan/Fluoride 2nd Triclosan/Fluoride 1st, Fluoride 2nd
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluoride 1st , Triclosan/Fluoride 2nd Triclosan/Fluoride 1st, Fluoride 2nd
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
[Not Specified]
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 - DMD
Organization: Colgate Palmolive
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: NCT00981825    
Other Study ID Numbers: ER0-2007-SAL-01-GX
First Submitted: September 26, 2008
First Posted: September 22, 2009
Results First Submitted: September 26, 2008
Results First Posted: September 22, 2009
Last Update Posted: June 14, 2011