Does Use of Rigid Fixation After Removing Distraction Osteogenesis Device Reduce the Relapse?
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|ClinicalTrials.gov Identifier: NCT02350803|
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : January 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cleft Palate Maxillary Hypoplasia Maxillary Retrognathism||Device: mini plate||Phase 2|
All patients were undergo maxillary Lefort 1 osteotomy with intra oral distractors bilaterally. The latency phase was considered 5 days for all of them. Distraction was done in the anterior- posterior vector with 1 mm/day rate. In group 1 distraction devices were removed after finishing distraction and a 3 months consolation, in group 2 fixation devices (4 L shaped miniplates with 16 screws) were placed immediately after removing distractors.
The amount of horizontal and vertical relapse were determined in the "A point" 2 years after finishing distraction.
By using lateral cephalogram X-ray as a raw data base, taken in 3 occasions: preoperatively, immediately after finishing consolation phase and removing distractor with placing fixation devices or without them and 2 years postoperatively in every subject. Relevant skeletal points were determined and digitized to evaluate 2-dimensional skeletal changes during and after surgery and to subsequently determine the amount of relapse. The same X-ray machine and settings were used for all cephalograms.Patients were stabilized in the lateral Cephalogram unit (Planmeca, ProMax, Helsinki-Finland) using Cephalostat. With the position of the patients with their head oriented at 90 degree angle to the X-Ray beam at a distance of 5ft from the tube. The jaws were in maximum intercuspation, tip of the tongue behind the upper incisor teeth and lips in relaxed position. The receptor (CR, Konica Minolta medical imaging, USA) was placed 15 inches from the head. This is a standard under which all cephalometric radiographs are taken. It ensures that radiographs, taken in different times, are directly comparable.
Radiographic exposures were 60-80 Kvp, 10-15 mA, and 16-32 sec, and repeated for each case in three occasions.
The radiographs were processed in laser readout processor special for mentioned CR system. PACS. A DICOM system used for saving and transferring the images.
All Lateral cephalograms were traced by hand and digitized, superimposed and evaluated by the same examiner. The tracings were rechecked by another examiner.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Dose Use of Rigid Fixation After Removing the Distraction Device Reduce the Anterior-posterior Relapse or Not?|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||December 2014|
Placebo Comparator: distraction osteogenesis
treatment of maxillary deficiency was done just by distraction osteogenesis and no mini plate was used after removal of distractor
Active Comparator: distraction osteogenesis+ mini plate
treatment of maxillary deficiency was done just by distraction osteogenesis and after removal of distractor 4 mini plate L shaped was used after removal of distractor as an intervention
Device: mini plate
in the intervention group, 4 L shaped titanium mini plates with 16 screws were fixed immediately after distraction phase and removal of distraction ossteogenesis to prevent the relapse after distraction
- "A point" of lateral cephalometry X-ray [ Time Frame: 2 years after finishing the distraction ]"A point" is used to determine the horizontal and vertical relapse
- occlusal plane [ Time Frame: 2 years after distraction is finished ]changes in occlusal plane is determine to assess the amount of relapse
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350803
|Iran, Islamic Republic of|
|shiraz University of medical sciences|
|Shiraz, Fars, Iran, Islamic Republic of|
|Study Director:||Reza Tabrizi, DMD||Shiraz University of Medical Sciences|
|Principal Investigator:||Touba Karagah, DMD||Shiraz University of Medical Sciences|
|Principal Investigator:||Negin Matini, DMD||Shahid Beheshti University of Medical Sciences|