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

Primary Purpose

Cleft Palate, Maxillary Hypoplasia, Maxillary Retrognathism

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
mini plate
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Palate focused on measuring distraction osteogenesis, mini plate, Lefort 1 osteotomy

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • shiraz University of medical sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

distraction osteogenesis

distraction osteogenesis+ mini plate

Arm Description

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

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

Outcomes

Primary Outcome Measures

"A point" of lateral cephalometry X-ray
"A point" is used to determine the horizontal and vertical relapse

Secondary Outcome Measures

occlusal plane
changes in occlusal plane is determine to assess the amount of relapse

Full Information

First Posted
January 16, 2015
Last Updated
January 26, 2015
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02350803
Brief Title
Does Use of Rigid Fixation After Removing Distraction Osteogenesis Device Reduce the Relapse?
Official Title
Dose Use of Rigid Fixation After Removing the Distraction Device Reduce the Anterior-posterior Relapse or Not?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate, Maxillary Hypoplasia, Maxillary Retrognathism
Keywords
distraction osteogenesis, mini plate, Lefort 1 osteotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
distraction osteogenesis
Arm Type
Placebo Comparator
Arm Description
treatment of maxillary deficiency was done just by distraction osteogenesis and no mini plate was used after removal of distractor
Arm Title
distraction osteogenesis+ mini plate
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
mini plate
Intervention Description
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 Measure Information:
Title
"A point" of lateral cephalometry X-ray
Description
"A point" is used to determine the horizontal and vertical relapse
Time Frame
2 years after finishing the distraction
Secondary Outcome Measure Information:
Title
occlusal plane
Description
changes in occlusal plane is determine to assess the amount of relapse
Time Frame
2 years after distraction is finished

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Tabrizi, DMD
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Touba Karagah, DMD
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Negin Matini, DMD
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
shiraz University of medical sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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