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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03710512
Other study ID # EARLY RELAPSE AFTER MANDIBULAR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 11, 2018
Est. completion date December 30, 2019

Study information

Verified date October 2018
Source Universitair Ziekenhuis Brussel
Contact Veerle Van Mossevelde, Datanurse
Phone +32 2 476 31 34
Email veerle.vanmossevelde@uzbrussel.be
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 30, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers No
Gender All
Age group 10 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium Universitair Ziekenhuis Brussel Jette Vlaams Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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