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Collection of Gingival Crevicular Fluid From Periodontitis Patients

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00763048
First received: September 26, 2008
Last updated: June 10, 2011
Last verified: June 2011
History of Changes
Results First Received: August 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Gingival Diseases
Interventions: Drug: Fluoride
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
subjects were recruited by the PI at the clinical site

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened to meet medical and oral health criteria and then began a 1 week washout period with fluoride toothpaste.

Reporting Groups
  Description
A - Control Comparator Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
B - Active Comparator Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.

Participant Flow:   Overall Study
    A - Control Comparator     B - Active Comparator  
STARTED     21     18  
COMPLETED     21     18  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
A - Control Comparator Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
B - Active Comparator Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
Total Total of all reporting groups

Baseline Measures
    A - Control Comparator     B - Active Comparator     Total  
Number of Participants  
[units: participants]
 		  21     18     39  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     21     18     39  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  48  ± 12.7     49.8  ± 12.8     48.9  ± 12.6  
Gender  
[units: participants]
 		     
Female     10     6     16  
Male     11     12     23  
Region of Enrollment  
[units: participants]
 		     
United States     21     18     39  



  Outcome Measures
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1.  Primary:   Metabolite Associated With Inflammation (Cadaverine)   [ Time Frame: 6 weeks ]
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2.  Primary:   Metabolite Associated With Inflammation (Choline)   [ Time Frame: 6 weeks ]
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3.  Primary:   Metabolite Associated With Inflammation (Hypoxanthine)   [ Time Frame: 6 weeks ]
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4.  Primary:   Metabolite Associated With Inflammation (Inosine)   [ Time Frame: 6 weeks ]
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5.  Primary:   Metabolite Associated With Inflammation (Isoleucine)   [ Time Frame: 6 weeks ]
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6.  Primary:   Metabolite Associated With Inflammation (Leucine)   [ Time Frame: 6 weeks ]
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7.  Primary:   Metabolite Associated With Inflammation (Lysine)   [ Time Frame: 6 weeks ]
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Measure Type Primary
Measure Title Metabolite Associated With Inflammation (Lysine)
Measure Description One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time Frame 6 weeks  
Safety Issue No  

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
A - Control Comparator Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
B - Active Comparator Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.

Measured Values
    A - Control Comparator     B - Active Comparator  
Number of Participants Analyzed  
[units: participants]
 		  21     18  
Metabolite Associated With Inflammation (Lysine)  
[units: ion count]
Mean ± Standard Deviation 		  1.063873  ± 0.785917     1.09704  ± 1.149168  


Statistical Analysis 1 for Metabolite Associated With Inflammation (Lysine)
Groups [1] All groups
Method [2] t-test, 1 sided
P Value [3] 0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis states that there is no difference between groups.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



8.  Primary:   Metabolite Associated With Inflammation (Phenylalanine)   [ Time Frame: 6 weeks ]
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9.  Primary:   Metabolite Associated With Inflammation (Putrescine)   [ Time Frame: 6 weeks ]
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10.  Primary:   Metabolite Associated With Inflammation (Xanthine)   [ Time Frame: 6 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  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 more than 60 days but less than or equal to 180 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
Organization: Colgate Palmolive Co.
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: NCT00763048     History of Changes
Other Study ID Numbers: CRO-2007-GIN-05-GB
Study First Received: September 26, 2008
Results First Received: August 19, 2010
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration