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Emdogain and Straumann Bone Ceramic in Infrabony Defects

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.
ClinicalTrials.gov Identifier: NCT00906776
Recruitment Status : Terminated (Difficulty to recruit patients fulfilling inclusion criteria)
First Posted : May 21, 2009
Results First Posted : October 31, 2012
Last Update Posted : May 9, 2016
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Periodontitis
Interventions: Device: Emdogain PLUS
Device: Autogenous bone

  Participant Flow

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
Emdogain PLUS Straumann Emdogain in combination with Straumann BoneCeramic
Autogenous Bone Autogenous bone from the patient

Participant Flow:   Overall Study
    Emdogain PLUS   Autogenous Bone
STARTED   11   8 
COMPLETED   11   8 
NOT COMPLETED   0   0 



  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
Emdogain PLUS Straumann Emdogain in combination with Straumann BoneCeramic
Autogenous Bone Autogenous bone from the patient
Total Total of all reporting groups

Baseline Measures
   Emdogain PLUS   Autogenous Bone   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   8   19 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.9  (8.9)   31.9  (8.6)   34.8  (8.6) 
Gender 
[Units: Participants]
     
Female   7   4   11 
Male   4   4   8 


  Outcome Measures

1.  Primary:   Change in Clinical Attachment Level (CAL)   [ Time Frame: Baseline and 12 months ]

2.  Secondary:   Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect   [ Time Frame: Baseline and 6 months ]

3.  Secondary:   Change in Probing Pocket Depth (PPD)   [ Time Frame: Baseline and 12 months ]

4.  Secondary:   Change in Clinical Attachment Level (CAL)   [ Time Frame: Baseline and 6 months ]

5.  Secondary:   Change in Probing Pocket Depth (PPD)   [ Time Frame: Baseline and 6 months ]

6.  Secondary:   Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect   [ Time Frame: Baseline and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Prof Philippe Bouchard
Organization: Rotschild hospital
phone: +33614656947
e-mail: phbouch@noos.fr



Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00906776     History of Changes
Other Study ID Numbers: CR 01/05
First Submitted: May 19, 2009
First Posted: May 21, 2009
Results First Submitted: August 30, 2012
Results First Posted: October 31, 2012
Last Update Posted: May 9, 2016