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

NCT ID: NCT02350803

Last Updated: 2015-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-12-31

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.

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.

Conditions

Cleft Palate; Maxillary Hypoplasia; Maxillary Retrognathism

Keywords

distraction osteogenesis; mini plate; Lefort 1 osteotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

distraction osteogenesis

treatment of maxillary deficiency was done just by distraction osteogenesis and no mini plate was used after removal of distractor

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

mini plate

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Reza Tabrizi

Assistant professor of oral and maxillofacial surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reza Tabrizi, DMD

Role: STUDY_DIRECTOR

Shiraz University of Medical Sciences

Touba Karagah, DMD

Role: PRINCIPAL_INVESTIGATOR

Shiraz University of Medical Sciences

Negin Matini, DMD

Role: PRINCIPAL_INVESTIGATOR

Shahid Beheshti University of Medical Sciences

Locations

shiraz University of medical sciences

Shiraz, Fars, Iran

Countries

Iran

Other Identifiers

SUDO-1394

Identifier Type: -

Identifier Source: org_study_id