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

NCT02350803 | Completed Phase 2 DMC

• 1 other identifier: SUDO-1394
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Palate; Maxillary Hypoplasia; Maxillary Retrognathism

Keywords

distraction osteogenesis; mini plate; Lefort 1 osteotomy

Outcome Measures

Primary Outcomes (1)

• "A point" of lateral cephalometry X-ray

  "A point" is used to determine the horizontal and vertical relapse

  2 years after finishing the distraction

Secondary Outcomes (1)

• occlusal plane

  2 years after distraction is finished

Study Arms (2)

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

Device: mini plate

Interventions

mini plate 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

distraction osteogenesis+ mini plate

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

shiraz University of medical sciences

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Cleft Palate; Retrognathia

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mandibular Diseases

Study Officials

• Reza Tabrizi, DMD

  Shiraz University of Medical Sciences

  STUDY DIRECTOR

• Touba Karagah, DMD

  Shiraz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Negin Matini, DMD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of oral and maxillofacial surgery

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 30, 2015
• Study Start: February 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2014
• Last Updated: January 30, 2015

Record last verified: 2015-01

Locations

IR (1)