Evaluation of Early Relapse After Mandibular Lengthening Surgery

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Unknown status

CT.gov ID

NCT03710512

Collaborator

(none)

Enrollment

Location

15.6

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mandibular Hypoplasia Relapse	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 11, 2018

Anticipated Primary Completion Date :

Sep 1, 2019

Anticipated Study Completion Date :

Dec 30, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

early relapse by means of three dimensional color maps (CBCT) [the first 6 months postoperatively]
evaluation at the osteotomy gap, the position of the condyles, rami and chin

Secondary Outcome Measures

condylar resorption by means of three dimensional color maps (CBCT) [the first 6 months postoperatively]
a three-dimensional volumetric analysis of the condylar head and the glenoid cavity

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitair Ziekenhuis Brussel	Jette	Vlaams Brabant	Belgium	1090

Sponsors and Collaborators

Universitair Ziekenhuis Brussel

Investigators

Principal Investigator: Erica Coppey, MD, Universitair Ziekenhuis Brussel
Study Director: Maurice Mommaerts, Prof. Mult, Universitair Ziekenhuis Brussel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Veerle Van Mossevelde, Datanurse, Universitair Ziekenhuis Brussel

ClinicalTrials.gov Identifier:

NCT03710512

Other Study ID Numbers:

EARLY RELAPSE AFTER MANDIBULAR

First Posted:

Oct 18, 2018

Last Update Posted:

Oct 18, 2018

Last Verified:

Oct 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Veerle Van Mossevelde, Datanurse, Universitair Ziekenhuis Brussel

hydroset

Additional relevant MeSH terms:

Micrognathism

Recurrence

Study Results

No Results Posted as of Oct 18, 2018