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Completed

NCT Number: NCT02341443

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

Mandibular fractures represent approximately 50% of the total facial fractures and are commonly (more than half) presented in more than one location. A few simple fractures can be treated using a conservative approach. More often, however, mandibular fractures require stabilization using open reduction and internal fixation.

Simple mandibular fractures can be treated using non-rigid fixation techniques that rely on the load-sharing principle, by which stabilization is accomplished with both fixation devices and bone surfaces. On the other hand, more complex fractures with continuity defects or comminuted need to be handle using rigid fixation where the device assumes all the forces (load-bearing principle). These approaches are well established, whereas the level of evidence for the treatment of bilateral double mandibular fractures (DMF) is still scarce. In fact, which surgical treatment, or combination of treatments, leads to the best outcome and the lowest rate of complications in bilateral DMFs is an open question.

The purpose of this study is to assess the complication rate in patients suffering from bilateral DMF treated either using non-rigid fixation on both fracture sides or a combination of rigid fixation on one side and non-rigid fixation on the other side.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Helsinki, Finland

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About this study

Prospective data will be collected in 314 patients suffering from bilateral (double) mandibular fracture randomly treated either with non-rigid fixation on both fracture sides or a combination of rigid fixation on one side and non-rigid fixation on the other side. This is a study where patients will be treated per randomization to one of the two established treatments and followed for further clinical examination post-operatively at 6 weeks and 3 months after the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older at the date of the surgery
  • Diagnosis of bilateral (double) mandibular fracture located in:
  • Angle and body or
  • Angle and symphysis or
  • Body and symphysis
  • Dentition: Patients must have most of their maxillary and mandibular teeth present and it must be possible to identify proper occlusion. The application of intraoperative Mandibulo-maxillary fixation (MMF) using arch bars must be possible
  • Ability to understand the content of the patient information / Informed Consent Form
  • Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
  • Signed and dated IRB/EC-approved written informed consent

Exclusion criteria

  • Fractures displaying continuity defect or comminution
  • Fractures showing clinical signs of infection at presentation
  • Edentulous mandible fracture
  • Fractures requiring an extra-oral surgical approach
  • Concomitant maxillary fractures
  • Concomitant condylar fracture
  • Prior surgical treatment of the mandibular fracture(s)
  • Atrophy of the mandible (<20 mm vertical height) at the level of the fracture(s)
  • Polytrauma (i.e. severe injuries leading to life-threatening condition)
  • Prisoners
  • Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Treatment and study plan

implants

Procedure

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.

Other names: Open reduction and internal fixation

Primary outcomes

  1. Number of anticipated procedure- or condition-related Adverse Events

    Time frame: 6 weeks

Secondary outcomes

  1. Degree of displacement of the fracture

    Time frame: Pre-operatively (Day -1)

  2. Location of the tooth with respect to the line of fracture

    Time frame: Pre-operatively (Day -1)

  3. Mechanism of production of the fracture:

    Time frame: Pre-operatively (Day -1)

  4. Time in days between the occurrence of the injury and the surgery

    Time frame: Intraoperatively (Day 0)

  5. Length of the surgery

    Time frame: Intraoperatively (Day 0)

    Time in minutes from the first incision to skin closure

  6. Length of the hospital stay

    Time frame: Intraoperatively (Day 0)

    Time in days between the admission and the discharge of the (acute) hospital

  7. Characteristics of the hardware

    Time frame: Intraoperatively (Day 0)

    Characteristics of the hardware/device used to reduce the fracture concerning its shape, thickness and number or screws

  8. Use of antibiotics

    Time frame: Intraoperatively (Day 0)

    Administration of antibiotics during surgery

  9. Difficulty of application of the hardware

    Time frame: Intraoperatively (Day 0)

    Surgeon's own assessment of difficulty of application of the hardware from very easy to very difficult

  10. Dysfunction of the mandible

    Time frame: 6 weeks, 3 months

    Helkimo Index

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Collaborators

  • AOCMF

Registry information

Official study title

A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures

Acronym: DMFx

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 19, 2015
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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