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To Access the Effects of Mucositis in Adults With Dental Implants (implantitis)

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT01072201
First received: September 26, 2008
Last updated: September 29, 2010
Last verified: September 2010
Results First Received: September 26, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Mucositis
Interventions: Drug: Triclosan and Fluoride
Drug: 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Total Toothpaste Triclosan/copolymer/Fluoride
Ultrabrite Toothpaste sodium fluoride control(placebo)

Participant Flow:   Overall Study
    Total Toothpaste   Ultrabrite Toothpaste
STARTED   30   30 
COMPLETED   30   29 
NOT COMPLETED   0   1 
Lost to Follow-up                0                1 



  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.
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Reporting Groups
  Description
Total Toothpaste Triclosan/copolymer/Fluoride
Ultrabrite Toothpaste sodium fluoride control (placebo)
Total Total of all reporting groups

Baseline Measures
   Total Toothpaste   Ultrabrite Toothpaste   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   26   26   52 
>=65 years   4   4   8 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.36  (7.38)   57.83  (7.97)   57.59  (7.61) 
Gender 
[Units: Participants]
     
Female   20   21   41 
Male   10   9   19 
Region of Enrollment 
[Units: Participants]
     
Italy   30   30   60 


  Outcome Measures
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1.  Primary:   Bleeding on Probing   [ Time Frame: 6 months ]

2.  Primary:   Mean Pocket Depth   [ Time Frame: 6 Months ]

3.  Primary:   Mean Percentage of Plaque Scores   [ Time Frame: 6 Months ]


  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
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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 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 De Vizio, DMD
Organization: Colgate Palmolive Co
phone: 732-878-7901
e-mail: William_Devizio@colpal.com



Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT01072201     History of Changes
Other Study ID Numbers: CRO-0107-PERIO-MUC-ITA-PC
Study First Received: September 26, 2008
Results First Received: September 26, 2008
Last Updated: September 29, 2010
Health Authority: United States: Food and Drug Administration