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Does Use of Rigid Fixation After Removing Distraction Osteogenesis Device Reduce the Relapse?

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. Identifier: NCT02350803
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : January 30, 2015
Information provided by (Responsible Party):
Reza Tabrizi, Shiraz University of Medical Sciences

Brief Summary:
patients were enrolled by the inclusion criteria and were undergo lefort 1 maxillary osteotomy. after the latency phase the distraction was done in anterior- posterior vector. patients were divided by randomized allocation in 2 groups. in group 1 the distractor was removed after consolation phase, and in group 2 fixation devices were placed immediately after removal of distractors. data regarding relapse were analyzed by lateral cephalogram X-ray taken in 3 different phases of the trial. change of occlusal plane and the "A point" of the cephalometric analysis were determined as reference point of the study.

Condition or disease Intervention/treatment Phase
Cleft Palate Maxillary Hypoplasia Maxillary Retrognathism Device: mini plate Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. "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

Secondary Outcome Measures :
  1. occlusal plane [ Time Frame: 2 years after distraction is finished ]
    changes in occlusal plane is determine to assess the amount of relapse

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Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

patients need lefort 1 maxillary advancement more than 8 mm and have presurgical orthodontic preparation

Exclusion Criteria:

patients with cleft lip and alveolar cleft ,traumatic patients ,patients with previous orthognathic surgery in the maxilla and edentulous patients

Information from the National Library of Medicine

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 identifier (NCT number): NCT02350803

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Iran, Islamic Republic of
shiraz University of medical sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
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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

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Responsible Party: Reza Tabrizi, Assistant professor of oral and maxillofacial surgery, Shiraz University of Medical Sciences Identifier: NCT02350803     History of Changes
Other Study ID Numbers: SUDO-1394
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015
Keywords provided by Reza Tabrizi, Shiraz University of Medical Sciences:
distraction osteogenesis
mini plate
Lefort 1 osteotomy
Additional relevant MeSH terms:
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Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities
Mandibular Diseases