Evaluation of Early Relapse After Mandibular Lengthening Surgery

NCT03710512 | Unknown

• 1 other identifier: EARLY RELAPSE AFTER MANDIBULAR
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Mandibular Hypoplasia; Relapse

Keywords

hydroset

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• condylar resorption by means of three dimensional color maps (CBCT)

  the first 6 months postoperatively

Study Arms (2)

hydroset

patients receiving hydroset at osteotomy site

Procedure: Bilateral sagittal split osteotomy

Control

patients not receiving hydroset at osteotomy site

Procedure: Bilateral sagittal split osteotomy

Interventions

Bilateral sagittal split osteotomy PROCEDURE

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

Control; hydroset

Eligibility Criteria

• Age: 10 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Class II occlusion of non-syndromic origin, mandibular hypoplasia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Micrognathism; Recurrence

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erica Coppey, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Maurice Mommaerts, Prof. Mult

  Universitair Ziekenhuis Brussel

  STUDY DIRECTOR

Central Study Contacts

Veerle Van Mossevelde, Datanurse

CONTACT

+32 2 476 31 34; veerle.vanmossevelde@uzbrussel.be

Annelies De Cock, Datanurse

CONTACT

+32 2 474 99 06; annelies.decock@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Datanurse

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: October 18, 2018
• Study Start: September 11, 2018
• Primary Completion: September 1, 2019
• Study Completion: December 30, 2019
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

BE (1)