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Clinical Study to Evaluate Dental Plaque

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ClinicalTrials.gov Identifier: NCT00758290
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : November 25, 2008
Last Update Posted : November 25, 2008
Information provided by:

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Gingival Diseases
Interventions: Drug: Triclosan/Fluoride
Drug: Fluoride/triclosan

  Participant Flow

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

Participant Flow:   Overall Study
    Fluoride/Triclosan   Triclosan/Fluoride
STARTED   11   12 
COMPLETED   11   12 

  Baseline Characteristics

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
Fluoride/Triclosan No text entered.
Triclosan/Fluoride No text entered.
Total Total of all reporting groups

Baseline Measures
   Fluoride/Triclosan   Triclosan/Fluoride   Total 
Overall Participants Analyzed 
[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 
[1] Twenty four panelists were enrolled, but 1 was discontinued due to non-compliance with study visits. Twenty three panelists comleted study.
[Units: Years]
Mean (Standard Deviation)
 32.5  (11.7)   30.3  (7.1)   31.4  (9.4) 
[Units: Participants]
Female   11   8   19 
Male   0   4   4 
Region of Enrollment 
[Units: Participants]
United States   11   12   23 

  Outcome Measures

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

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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

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
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: October 16, 2008
Results First Posted: November 25, 2008
Last Update Posted: November 25, 2008