- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02350803
Does Use of Rigid Fixation After Removing Distraction Osteogenesis Device Reduce the Relapse?
Dose Use of Rigid Fixation After Removing the Distraction Device Reduce the Anterior-posterior Relapse or Not?
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Fars
-
Shiraz, Fars, Iran, Islamic Republic of
- shiraz University of medical sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"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
|
2 years after finishing the distraction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
occlusal plane
Time Frame: 2 years after distraction is finished
|
changes in occlusal plane is determine to assess the amount of relapse
|
2 years after distraction is finished
|
Collaborators and Investigators
Investigators
- Principal Investigator: Touba Karagah, DMD, shiraz University of medical sciences
- Study Director: Reza Tabrizi, DMD, shiraz University of medical sciences
- Principal Investigator: Negin Matini, DMD, Shahid Beheshti University of Medical Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Congenital Abnormalities
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Mouth Abnormalities
- Stomatognathic System Abnormalities
- Jaw Abnormalities
- Jaw Diseases
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Mandibular Diseases
- Cleft Palate
- Retrognathia
Other Study ID Numbers
- SUDO-1394
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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