Evaluating Commercial Anti-Plaque Products and Oral Rinse

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT01014143
First received: September 26, 2008
Last updated: June 10, 2011
Last verified: June 2011
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: Chlorhexidine digluconate
Drug: Fluoride, triclosan

  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
Recruitment was performed by the 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 Toothpaste First Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
Total Toothpaste First triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
Chlorhexidine Oral Rinse First chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last

Participant Flow for 5 periods

Period 1:   First Intervention
    Fluoride Toothpaste First     Total Toothpaste First     Chlorhexidine Oral Rinse First  
STARTED     10     9     9  
COMPLETED     10     9     9  
NOT COMPLETED     0     0     0  

Period 2:   Washout Period After 1st Intervention
    Fluoride Toothpaste First     Total Toothpaste First     Chlorhexidine Oral Rinse First  
STARTED     10     9     9  
COMPLETED     10     9     9  
NOT COMPLETED     0     0     0  

Period 3:   Second Intervention
    Fluoride Toothpaste First     Total Toothpaste First     Chlorhexidine Oral Rinse First  
STARTED     10     9     9  
COMPLETED     8     9     9  
NOT COMPLETED     2     0     0  
Lost to Follow-up                 2                 0                 0  

Period 4:   Washout After 2nd Intervention
    Fluoride Toothpaste First     Total Toothpaste First     Chlorhexidine Oral Rinse First  
STARTED     8     9     9  
COMPLETED     8     9     9  
NOT COMPLETED     0     0     0  

Period 5:   Third Intervention
    Fluoride Toothpaste First     Total Toothpaste First     Chlorhexidine Oral Rinse First  
STARTED     8     9     9  
COMPLETED     8     9     9  
NOT COMPLETED     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 Toothpaste negative control
Total Toothpaste triclosan/fluoride toothpaste (positive control toothpaste)
Chlorhexidine Oral Rinse chlorhexidine mouthrinse (positive control rinse)
Total Total of all reporting groups

Baseline Measures
    Fluoride Toothpaste     Total Toothpaste     Chlorhexidine Oral Rinse     Total  
Number of Participants  
[units: participants]
  10     9     9     28  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     10     9     9     28  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  47.6  ± 15.1     39  ± 9.2     47.2  ± 9.6     44.5  ± 11.7  
Gender  
[units: participants]
       
Female     7     6     9     22  
Male     3     3     0     6  
Region of Enrollment  
[units: participants]
       
United States     10     9     9     28  



  Outcome Measures

1.  Primary:   Plaque Index   [ Time Frame: Four days ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
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: NCT01014143     History of Changes
Other Study ID Numbers: CRO-2007-PLA-15-RR
Study First Received: September 26, 2008
Results First Received: September 26, 2008
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration