Clinical Study to Evaluate Dental Plaque

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00758290
First received: September 23, 2008
Last updated: November 20, 2008
Last verified: November 2008
Results First Received: October 16, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Gingival Diseases
Interventions: Drug: Triclosan/Fluoride
Drug: Fluoride/triclosan

  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/Triclosan No text entered.
Triclosan/Fluoride No text entered.

Participant Flow:   Overall Study
    Fluoride/Triclosan     Triclosan/Fluoride  
STARTED     11     12  
COMPLETED     11     12  
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/Triclosan No text entered.
Triclosan/Fluoride No text entered.
Total Total of all reporting groups

Baseline Measures
    Fluoride/Triclosan     Triclosan/Fluoride     Total  
Number of Participants  
[units: participants]
  11     12     23  
Age [1]
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     11     12     23  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  32.5  ± 11.7     30.3  ± 7.1     31.4  ± 9.4  
Gender  
[units: participants]
     
Female     11     8     19  
Male     0     4     4  
Region of Enrollment  
[units: participants]
     
United States     11     12     23  
[1] Twenty four panelists were enrolled, but 1 was discontinued due to non-compliance with study visits. Twenty three panelists comleted study.



  Outcome Measures

1.  Primary:   Dental Plaque Index   [ Time Frame: 4 Day ]


  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
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  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: NCT00758290     History of Changes
Other Study ID Numbers: CRO-2008-PLA-13-RR
Study First Received: September 23, 2008
Results First Received: October 16, 2008
Last Updated: November 20, 2008
Health Authority: United States: Food and Drug Administration