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Clinical Trials/NCT02350803
NCT02350803CompletedPhase 2

Dose Use of Rigid Fixation After Removing the Distraction Device Reduce the Anterior-posterior Relapse or Not?

Shiraz University of Medical Sciences1 site in 1 country20 target enrollmentStarted: February 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
"A point" of lateral cephalometry X-ray

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 28 Years (Adult)
Sex
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

Arms & Interventions

distraction osteogenesis

Placebo Comparator

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

distraction osteogenesis+ mini plate

Active Comparator

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

Intervention: mini plate (Device)

Outcomes

Primary Outcomes

"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 Outcomes

  • occlusal plane(2 years after distraction is finished)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Reza Tabrizi

Assistant professor of oral and maxillofacial surgery

Shiraz University of Medical Sciences

Study Sites (1)

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