Efficacy of Salivary Bacteria and Post Brushing

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00981825
First received: September 26, 2008
Last updated: June 10, 2011
Last verified: June 2011
Results First Received: September 26, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Salivary Bacteria Levels
Interventions: Drug: Fluoride
Drug: Triclosan/Fluoride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
At clinical site

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fluoride 1st , Triclosan/Fluoride 2nd Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period.
Triclosan/Fluoride 1st, Fluoride 2nd Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.

Participant Flow for 3 periods

Period 1:   First Intervention
    Fluoride 1st , Triclosan/Fluoride 2nd     Triclosan/Fluoride 1st, Fluoride 2nd  
STARTED     11     11  
COMPLETED     11     11  
NOT COMPLETED     0     0  

Period 2:   Washout After 1st Intervention
    Fluoride 1st , Triclosan/Fluoride 2nd     Triclosan/Fluoride 1st, Fluoride 2nd  
STARTED     11     11  
COMPLETED     11     11  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Fluoride 1st , Triclosan/Fluoride 2nd     Triclosan/Fluoride 1st, Fluoride 2nd  
STARTED     11     11  
COMPLETED     11     11  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fluoride 1st, Triclosan/Fluoride 2nd Fluoride toothpaste (placebo)
Triclosan/Fluoride 1st, Fluoride 2nd Triclosan/Fluoride toothpaste (experimental)
Total Total of all reporting groups

Baseline Measures
    Fluoride 1st, Triclosan/Fluoride 2nd     Triclosan/Fluoride 1st, Fluoride 2nd     Total  
Number of Participants  
[units: participants]
  11     11     22  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     11     11     22  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  30.8  ± 6.8     30.5  ± 8.7     30.6  ± 7.6  
Gender  
[units: participants]
     
Female     7     7     14  
Male     4     4     8  
Region of Enrollment  
[units: participants]
     
India     11     11     22  



  Outcome Measures

1.  Primary:   CFU (Colony Forming Units)   [ Time Frame: 4 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: William DeVizio - DMD
Organization: Colgate Palmolive
phone: 732-878-7901
e-mail: william_devizio@colpal.com


No publications provided


Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00981825     History of Changes
Other Study ID Numbers: ER0-2007-SAL-01-GX
Study First Received: September 26, 2008
Results First Received: September 26, 2008
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration