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Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00926328
First received: September 26, 2008
Last updated: August 8, 2013
Last verified: August 2013
Results First Received: September 26, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Gingivitis
Interventions: Drug: Triclosan, 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
Performed by the Research Department School of Dentistry UPR

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
Experimental Treatment triclosan/copolymer/fluoride toothpaste
Placebo Control sodium fluoride toothpaste

Participant Flow:   Overall Study
    Experimental Treatment     Placebo Control  
STARTED     60     60  
COMPLETED     48     46  
NOT COMPLETED     12     14  
Lost to Follow-up                 12                 14  



  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
Experimental Treatment triclosan/copolymer/fluoride toothpaste
Placebo Control sodium fluoride toothpaste
Total Total of all reporting groups

Baseline Measures
    Experimental Treatment     Placebo Control     Total  
Number of Participants  
[units: participants]
  60     60     120  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     58     58     116  
>=65 years     2     2     4  
Age  
[units: years]
Mean ± Standard Deviation
  34.72  ± 8.51     35.95  ± 10.24     35.33  ± 9.39  
Gender  
[units: participants]
     
Female     45     43     88  
Male     15     17     32  
Region of Enrollment  
[units: participants]
     
Spain     60     60     120  



  Outcome Measures
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1.  Primary:   Gingivitis Index   [ Time Frame: 6 months ]

2.  Primary:   Plaque Index   [ Time Frame: 6 Months ]


  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 De Vizio, DMD
Organization: Colgate Palmolive
phone: 732-878-7901
e-mail: William_Devizio@colpal.com


No publications provided


Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00926328     History of Changes
Other Study ID Numbers: CRO-0507-PL-SP-CT-BS
Study First Received: September 26, 2008
Results First Received: September 26, 2008
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration