Clinical Study to Compare Dental Plaque Control

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00758394
First received: September 23, 2008
Last updated: August 8, 2013
Last verified: August 2013
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: Dental Plaque
Interventions: Drug: Fluoride
Drug: Triclosan/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
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 First Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last
Triclosan/Fluoride First Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last
Triclosan/Fluoride/Arginine First Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last
Triclosan/Fluoride/Cavistat First Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last

Participant Flow for 7 periods

Period 1:   1st Intervention
    Fluoride First     Triclosan/Fluoride First     Triclosan/Fluoride/Arginine First     Triclosan/Fluoride/Cavistat First  
STARTED     8     7     6     8  
COMPLETED     8     7     6     8  
NOT COMPLETED     0     0     0     0  

Period 2:   Washout After 1st Intervention
    Fluoride First     Triclosan/Fluoride First     Triclosan/Fluoride/Arginine First     Triclosan/Fluoride/Cavistat First  
STARTED     8     7     6     8  
COMPLETED     8     7     6     8  
NOT COMPLETED     0     0     0     0  

Period 3:   2nd Intervention Order
    Fluoride First     Triclosan/Fluoride First     Triclosan/Fluoride/Arginine First     Triclosan/Fluoride/Cavistat First  
STARTED     8     7     6     8  
COMPLETED     8     6     6     8  
NOT COMPLETED     0     1     0     0  
Lost to Follow-up                 0                 1                 0                 0  

Period 4:   Washout After 2nd Intervention
    Fluoride First     Triclosan/Fluoride First     Triclosan/Fluoride/Arginine First     Triclosan/Fluoride/Cavistat First  
STARTED     8     6     6     8  
COMPLETED     8     6     6     8  
NOT COMPLETED     0     0     0     0  

Period 5:   3rd Intervention
    Fluoride First     Triclosan/Fluoride First     Triclosan/Fluoride/Arginine First     Triclosan/Fluoride/Cavistat First  
STARTED     8     6     6     8  
COMPLETED     7     6     6     7  
NOT COMPLETED     1     0     0     1  
Lost to Follow-up                 1                 0                 0                 1  

Period 6:   Washout After 3rd Intervention
    Fluoride First     Triclosan/Fluoride First     Triclosan/Fluoride/Arginine First     Triclosan/Fluoride/Cavistat First  
STARTED     7     6     6     7  
COMPLETED     7     6     6     7  
NOT COMPLETED     0     0     0     0  

Period 7:   4th Intervention
    Fluoride First     Triclosan/Fluoride First     Triclosan/Fluoride/Arginine First     Triclosan/Fluoride/Cavistat First  
STARTED     7     6     6     7  
COMPLETED     7     6     6     7  
NOT COMPLETED     0     0     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 - A Negative control
Fluoride/Triclosan - B Positive control comparator
Triclosan/Fluoride/Arginine toothpaste containing amino acid
Triclosan/Fluoride/Cavistat toothpaste containing bicarbonate
Total Total of all reporting groups

Baseline Measures
    Fluoride - A     Fluoride/Triclosan - B     Triclosan/Fluoride/Arginine     Triclosan/Fluoride/Cavistat     Total  
Number of Participants  
[units: participants]
  8     7     6     8     29  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     8     7     6     8     29  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  30.5  ± 10.8     29.7  ± 8.7     36.4  ± 11.6     37.8  ± 5.0     33.6  ± 9.5  
Gender  
[units: participants]
         
Female     6     7     6     4     23  
Male     2     0     0     4     6  
Region of Enrollment  
[units: participants]
         
United States     8     7     6     8     29  



  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
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 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: NCT00758394     History of Changes
Other Study ID Numbers: CRO-0907-PLA-14-RR
Study First Received: September 23, 2008
Results First Received: October 16, 2008
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration