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Investigate Plaque and Gingival Index

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00762762
First received: September 26, 2008
Last updated: April 2, 2012
Last verified: April 2012
History of Changes
Results First Received: April 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Periodontitis
Interventions: Drug: Triclosan and fluoride
Drug: 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
all subjects were recruited by the PI at the clinical site.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
all subjects pass a medical exam and meet the study inclusion/exclusion criteria.

Reporting Groups
  Description
Active Comparator triclosan/fluoride/copolymer toothpaste
Placebo Comparator Anti-cavity, fluoride oral rinse

Participant Flow:   Overall Study
    Active Comparator     Placebo Comparator  
STARTED     30     30  
COMPLETED     22     20  
NOT COMPLETED     8     10  
Did not report for appointments                 8                 10  



  Baseline Characteristics
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Reporting Groups
  Description
Active Comparator triclosan/fluoride/copolymer toothpaste
Placebo Comparator Anti-cavity, fluoride oral rinse
Total Total of all reporting groups

Baseline Measures
    Active Comparator     Placebo Comparator     Total  
Number of Participants  
[units: participants]
 		  30     30     60  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     30     30     60  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  50.6  ± 7.5     48.8  ± 8.7     49.7  ± 8.1  
Gender  
[units: participants]
 		     
Female     13     13     26  
Male     17     17     34  
Region of Enrollment  
[units: participants]
 		     
Australia     30     30     60  



  Outcome Measures
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1.  Primary:   HbA1c Levels in Blood   [ Time Frame: 12 months ]
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2.  Primary:   High Sensitivity CRP (C-Reactive Protein)   [ Time Frame: 12 months ]
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3.  Primary:   C-Peptide   [ Time Frame: 12 months ]
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4.  Primary:   IL-6 (Interleukin - 6)   [ Time Frame: 12 months ]
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5.  Primary:   TNF-α (Tumor Necrosis Factor - Alpha)   [ Time Frame: 12 months ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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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 more than 60 days but less than or equal to 180 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.


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.  


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


No publications provided


Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00762762     History of Changes
Other Study ID Numbers: 2004000685
Study First Received: September 26, 2008
Results First Received: April 2, 2012
Last Updated: April 2, 2012
Health Authority: United States: Food and Drug Administration