We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Study to Compare Dental Plaque Control

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758394
First Posted: September 25, 2008
Last Update Posted: August 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Colgate Palmolive
Results First Submitted: October 16, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Dental Plaque
Interventions: Drug: Fluoride
Drug: Triclosan/Fluoride

  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
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
  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 - 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 
Overall Participants Analyzed 
[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
  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



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
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: October 16, 2008
Results First Posted: November 19, 2008
Last Update Posted: August 15, 2013