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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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03710512
Enrollment
50
Registered
2018-10-18
Start date
2018-09-11
Completion date
2019-12-30
Last updated
2018-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular Hypoplasia, Relapse

Keywords

hydroset

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

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.

Interventions

Bilateral sagittal split osteotomy of the mandible is a surgical procedure used to correct dentofacial discrepancies

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
early relapse by means of three dimensional color maps (CBCT)the first 6 months postoperativelyevaluation at the osteotomy gap, the position of the condyles, rami and chin

Secondary

MeasureTime frameDescription
condylar resorption by means of three dimensional color maps (CBCT)the first 6 months postoperativelya three-dimensional volumetric analysis of the condylar head and the glenoid cavity

Countries

Belgium

Contacts

Primary ContactVeerle Van Mossevelde, Datanurse
veerle.vanmossevelde@uzbrussel.be+32 2 476 31 34
Backup ContactAnnelies De Cock, Datanurse
annelies.decock@uzbrussel.be+32 2 474 99 06

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026