Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00966953
First received: September 26, 2008
Last updated: September 14, 2009
Last verified: September 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: Gingival Diseases
Interventions: Drug: Fluoride
Drug: Triclosan/Fluoride toothpaste
Other: antibacterial plant extract

  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
The dental clinic staff recruited for this study.

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 Control, Magnolol,Total/Whitening,Honokiol 1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
Total/Whitening, Honokiol, Fluoride Control, Magnolol 1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
Honokiol, Fluoride Control, Magnolol, Total/Whitening 1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
Magnolol, Total/Whitening, Honokiol, Fluoride Control 1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control

Participant Flow for 7 periods

Period 1:   1st Intervention
    Fluoride Control, Magnolol,Total/Whitening,Honokiol     Total/Whitening, Honokiol, Fluoride Control, Magnolol     Honokiol, Fluoride Control, Magnolol, Total/Whitening     Magnolol, Total/Whitening, Honokiol, Fluoride Control  
STARTED     6     6     6     7  
COMPLETED     6     6     6     7  
NOT COMPLETED     0     0     0     0  

Period 2:   1 Week Washout After 1st Intervention
    Fluoride Control, Magnolol,Total/Whitening,Honokiol     Total/Whitening, Honokiol, Fluoride Control, Magnolol     Honokiol, Fluoride Control, Magnolol, Total/Whitening     Magnolol, Total/Whitening, Honokiol, Fluoride Control  
STARTED     6     6     6     7  
COMPLETED     6     6     6     7  
NOT COMPLETED     0     0     0     0  

Period 3:   2nd Intervention
    Fluoride Control, Magnolol,Total/Whitening,Honokiol     Total/Whitening, Honokiol, Fluoride Control, Magnolol     Honokiol, Fluoride Control, Magnolol, Total/Whitening     Magnolol, Total/Whitening, Honokiol, Fluoride Control  
STARTED     6     6     6     7  
COMPLETED     6     6     6     7  
NOT COMPLETED     0     0     0     0  

Period 4:   1 Week Washout After 2nd Intervention
    Fluoride Control, Magnolol,Total/Whitening,Honokiol     Total/Whitening, Honokiol, Fluoride Control, Magnolol     Honokiol, Fluoride Control, Magnolol, Total/Whitening     Magnolol, Total/Whitening, Honokiol, Fluoride Control  
STARTED     6     6     6     7  
COMPLETED     6     6     6     7  
NOT COMPLETED     0     0     0     0  

Period 5:   3rd Intervention Order
    Fluoride Control, Magnolol,Total/Whitening,Honokiol     Total/Whitening, Honokiol, Fluoride Control, Magnolol     Honokiol, Fluoride Control, Magnolol, Total/Whitening     Magnolol, Total/Whitening, Honokiol, Fluoride Control  
STARTED     6     6     6     7  
COMPLETED     6     6     6     7  
NOT COMPLETED     0     0     0     0  

Period 6:   1 Week Washout After 3rd Intervention
    Fluoride Control, Magnolol,Total/Whitening,Honokiol     Total/Whitening, Honokiol, Fluoride Control, Magnolol     Honokiol, Fluoride Control, Magnolol, Total/Whitening     Magnolol, Total/Whitening, Honokiol, Fluoride Control  
STARTED     6     6     6     7  
COMPLETED     6     6     6     7  
NOT COMPLETED     0     0     0     0  

Period 7:   4th Intervention Order
    Fluoride Control, Magnolol,Total/Whitening,Honokiol     Total/Whitening, Honokiol, Fluoride Control, Magnolol     Honokiol, Fluoride Control, Magnolol, Total/Whitening     Magnolol, Total/Whitening, Honokiol, Fluoride Control  
STARTED     6     6     6     7  
COMPLETED     6     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 Control, Magnolol,Total/Whitening,Honokiol 1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
Total/Whitening, Honokiol, Fluoride Control, Magnolol 1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
Honokiol, Fluoride Control, Magnolol, Total/Whitening 1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
Magnolol, Total/Whitening, Honokiol, Fluoride Control 1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
Total Total of all reporting groups

Baseline Measures
    Fluoride Control, Magnolol,Total/Whitening,Honokiol     Total/Whitening, Honokiol, Fluoride Control, Magnolol     Honokiol, Fluoride Control, Magnolol, Total/Whitening     Magnolol, Total/Whitening, Honokiol, Fluoride Control     Total  
Number of Participants  
[units: participants]
  6     6     6     7     25  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     6     6     6     7     25  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  42  ± 11.8     37.8  ± 11.6     46.4  ± 10.9     44.3  ± 7     42.1  ± 10.5  
Gender  
[units: participants]
         
Female     2     3     3     7     15  
Male     4     3     3     0     10  
Region of Enrollment  
[units: participants]
         
United States     6     6     6     7     25  



  Outcome Measures

1.  Primary:   Plaque Index   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information