Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT01024738
First received: September 26, 2008
Last updated: November 27, 2009
Last verified: October 2009
Results First Received: September 26, 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: Dental Plaque
Interventions: Drug: Fluoride
Drug: Triclosan, fluoride
Drug: Chlorhexidine Gluconate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Performed at the clinic

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 Toothpaste First Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last
Triclosan/Fluoride Toothpaste First triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last
Chlorhexidine Oral Rinse chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last

Participant Flow for 5 periods

Period 1:   First Intervention:
    Fluoride Toothpaste First     Triclosan/Fluoride Toothpaste First     Chlorhexidine Oral Rinse  
STARTED     7     7     8  
COMPLETED     7     7     8  
NOT COMPLETED     0     0     0  

Period 2:   Washout After 1st Intervention
    Fluoride Toothpaste First     Triclosan/Fluoride Toothpaste First     Chlorhexidine Oral Rinse  
STARTED     7     7     8  
COMPLETED     7     7     8  
NOT COMPLETED     0     0     0  

Period 3:   Second Intervention:
    Fluoride Toothpaste First     Triclosan/Fluoride Toothpaste First     Chlorhexidine Oral Rinse  
STARTED     7     7     8  
COMPLETED     7     7     8  
NOT COMPLETED     0     0     0  

Period 4:   Washout After 2nd Intervention
    Fluoride Toothpaste First     Triclosan/Fluoride Toothpaste First     Chlorhexidine Oral Rinse  
STARTED     7     7     8  
COMPLETED     7     7     8  
NOT COMPLETED     0     0     0  

Period 5:   Third Intervention:
    Fluoride Toothpaste First     Triclosan/Fluoride Toothpaste First     Chlorhexidine Oral Rinse  
STARTED     7     7     8  
COMPLETED     7     7     8  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
  Hide 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
  Description
Fluoride Toothpaste negative control toothpaste
Total Toothpaste triclosan/fluoride toothpaste (positive control)
Chlorhexidine Oral Rinse chlorhexidine oral rinse (positive control)
Total Total of all reporting groups

Baseline Measures
    Fluoride Toothpaste     Total Toothpaste     Chlorhexidine Oral Rinse     Total  
Number of Participants  
[units: participants]
  7     7     8     22  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     7     7     8     22  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  44.2  ± 10.23     50.5  ± 6.5     56.6  ± 5.5     50.43  ± 8.86  
Gender  
[units: participants]
       
Female     7     6     7     20  
Male     0     1     1     2  
Region of Enrollment  
[units: participants]
       
United States     7     7     8     22  



  Outcome Measures

1.  Primary:   Plaque Index   [ Time Frame: 4 Days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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


No publications provided


Responsible Party: William DeVizio/VP, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT01024738     History of Changes
Other Study ID Numbers: CRO-2008-PLA-05-RR
Study First Received: September 26, 2008
Results First Received: September 26, 2008
Last Updated: November 27, 2009
Health Authority: United States: Food and Drug Administration