Evaluation of Early Relapse After Mandibular Lengthening Surgery

Evaluation of Early Relapse After Mandibular Lengthening Surgery With or Without the Use of a Bone Graft Substitute at the Osteotomy Site.

The goal of this study is to evaluate whether the use of a bone graft substitute at the osteotomy site will result in better stability and diminish early relapse after mandibular lengthening surgery.

The study focuses on the evaluation of the following hypothesis:

The use of bone graft substitute at the osteotomy site has an influence on:

• The 3-dimensional stability of the osteotomy site
• Early relapse based in the plasticity of the site

Study Overview

• Status: Unknown
• Conditions: Relapse; Mandibular Hypoplasia
• Intervention / Treatment: Procedure: Bilateral sagittal split osteotomy

Detailed Description

Bilateral sagittal split osteotomy (BSSO)of the mandible is a surgical procedure used to correct dentofacial discrepancies. Post-operative stability is of great concern for CMF (Cranio maxillo facial) surgeons as the goal is to achieve optimal functional outcomes, good aesthetic results and satisfaction of patients' concerns. Skeletal relapse is a known complication of mandibular lengthening surgery and is divided into two groups; short term or early relapse and long term or late relapse.

Short term relapse occurs within the first 6 to 8 weeks post-operatively and is due to intersegmental movement at the osteotomy site (osteotomy slippage) and osteosynthesis slippage. Late relapse is thought to be caused by progressive condylar resorption, a clinical entity affecting the temporomandibular joint.

The rationale to reconstruct the lateral cortical defect resulting from mandibular advancement with BSSO with a bone graft substitute lies in the prevention of an unaesthetic notching at the inferior border. The use of a self-hardening, space-occupying paste could add mechanical stability, thus increase 3D-stability at the osteotomy site and prevent early relapse.

The use of cone-beam computed tomography (CBCT) in the treatment planning and postoperative follow-up of orthognathic patients has provided the surgeons with a new three-dimensional imaging modality to evaluate the postoperative skeletal relapse and postoperative morphologic changes of the condyles. Skeletal relapse, as well as positional and dimensional changes of the condyles, can be quantified in three dimensions.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Jette, Vlaams Brabant, Belgium, 1090
      • Recruiting
      • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Class II occlusion of non-syndromic origin, mandibular hypoplasia

Description

Inclusion Criteria:

• Class II occlusion of non-syndromic origin, mandibular hypoplasia
• Availability of pre- and postoperative CBCT scans of sufficient quality
• Age: >10years

Exclusion Criteria:

• Previous orthognathic surgical treatment
• Simultaneously performed genioplasty
• Plate osteosynthesis
• Buccal plate fracture during surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
hydroset; patients receiving hydroset at osteotomy site	Procedure: Bilateral sagittal split osteotomy; Bilateral sagittal split osteotomy of the mandible is a surgical procedure used to correct dentofacial discrepancies
Control; patients not receiving hydroset at osteotomy site	Procedure: Bilateral sagittal split osteotomy; Bilateral sagittal split osteotomy of the mandible is a surgical procedure used to correct dentofacial discrepancies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
early relapse by means of three dimensional color maps (CBCT)	evaluation at the osteotomy gap, the position of the condyles, rami and chin	the first 6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
condylar resorption by means of three dimensional color maps (CBCT)	a three-dimensional volumetric analysis of the condylar head and the glenoid cavity	the first 6 months postoperatively

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Erica Coppey, MD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 11, 2018
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): December 30, 2019

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (ACTUAL): October 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: hydroset
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Recurrence; Micrognathism
• Other Study ID Numbers: EARLY RELAPSE AFTER MANDIBULAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No