A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures

NACompletedINTERVENTIONAL
Enrollment

314

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

March 31, 2019

Study Completion Date

May 31, 2019

Conditions
Mandibular Fractures
Interventions
PROCEDURE

Implants

"Experimental arm: Rigid~Surgical treatment using arch bars and according to the following fixation:~Rigid fixation on one side (most anterior fracture) and non-rigid fixation on the other (most posterior fracture).~Active comparator: Non-rigid~Surgical treatment using arch bars and according to the following fixation:~Non-rigid fixation on both fracture sides.~Whereas non-rigid fixation is defined as a single miniplate of ≤1.00 mm thickness, and rigid fixation is defined as a single plate of ≥1.25 mm thickness, a combination of 2 plates or a 3D geometric plate."

Trial Locations (11)

10461

Jacobi Medical Center, New York

78229-3900

UT Health Science Center at San Antonio, San Antonio

00029

Helsinki University Hospital, Helsinki

Unknown

University Medical Center Hamburg-Eppendorf, Hamburg

Ludwig-Maximillians University, München

Hospital Sg Buloh, Sungai Buloh

Hamad Medical Corporation, Doha

Emergency Clinical County Hospital of Constanta, Constanța

King Edward VIII Hospital, Durban

12 de Octubre University Hospital, Madrid

Lviv Regional Clinical Hospital (Lviv National Medical University), Lviv

All Listed Sponsors
collaborator

AOCMF

OTHER

lead

AO Clinical Investigation and Publishing Documentation

OTHER

NCT02341443 - A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures | Biotech Hunter | Biotech Hunter