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NCT Number: NCT07153120

Erich Arch Bars, IMF Screws and Hybrid Arch Bars in the Management of Mandibular Fractures

Treatment options of mandibular fractures can be accomplished with either closed treatment or open reduction internal fixation (ORIF). Maxillomandibular fixation (MMF) refers to any method used to secure the maxilla and mandible in proper dental occlusion. MMF is a standard component of mandibular fracture management essential for closed treatment and commonly used du ring ORIF. Its three main principles are to establish occlusion, provide stability, and immobilize the jaws.

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Key information

Conditions

Mandibular Fractures Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Egypt

About this study

An abundance of modalities used for establishing MMF have been reported in the literature. Traditionally, Ivy eyelets wiring, Risdon wiring, metal splints, acrylic splints and Erich arch bars are used. Progressively, new techniques such as Intermaxillary Fixation (IMF) screws, wiring around single tooth with tight contacts, use of 2 miniplates, use of zip ties, use of bondable buttons and 2 looped wires have been developed to expedite securement of MMF.

The conventional MMF procedure uses arch bars of malleable strips of steel-bearing hooks, also known as Erich arch bars (EABs), allowing hands-free achievement and maintenance of excellent intraoperative occlusion with reproducibility.

However, the placement of Erich arch bars (EABs) fixated to the dentition with circumdental stainless-steel wires has been the standard practice for MMF for or during the repair of mandibular fractures for many decades.

Most of these techniques are limited in the setting of poor dentition or in patients who are partially edentulous, in addition of being time consuming, and are associated with risks of mucosal, dental, and needlestick injuries.

A hybrid arch bar (HAB) for MMF has been introduced to overcome some disadvantages of conventional arch bars. The HAB differs from the EAB because they are secured directly to the alveolar bone with screws rather than using teeth for anchorage.

Some authors suggest that IMF screws are less time consuming, provide better oral hygiene and reduce the risk of needle stick injury. Conversely, IMF screws have been associated with teeth root damage and screw loosening which can compromise MMF. Despite these disadvantages, IMF screws remain a recommended alternative to traditional arch bars for management of maxillofacial trauma.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with mandibular fracture indicated for MMF. (Favorable fractures, minimally displaced).
  • Patients with an age range from 18:50 years old.
  • Patients free from any systemic diseases.

Exclusion criteria

  • Patients that are not willing to participate in this clinical trial.
  • Edentulous patients or those with inadequate dentition for occlusal guidance
  • Pathological fractures.
  • Patients with absolute or relative contraindications to MMF (e.g. pregnancy, mental disorders and systemic diseases).

Treatment and study plan

Erich Arch Bars

Device

Stainless steel plates with hooks for wire placement are adapted over the facial aspect of teeth so the wires would be inserted to go around the necks of teeth (circumdental wiring), then both maxillary and mandibular plates are ligated to each other in order to achieve MMF.

Hybrid Arch Bars

Device

Screw retained titanium plates with hooks for wires are adapted properly then self drilling self locking screws will be drilled in between roots of teeth to avoid injury, after fixation both jaws will be wired to accomplish MMF

IMF Screws

Device

A total of four self drilling screws two in the maxilla and the other two in the mandible will be inserted in the bone above and below teeth roots apices to avoid injury, to be ligated to each other in a vertical and an X pattern to achieve MMF.

Primary outcomes

  1. Occlusal Stability/instability: clinically assessed (Chairside)

    Time frame: Four to six weeks

    Stability categorizations:

    • Stable: center of force hasn't shifted showing clinically balanced forces across the dental arch
    • Unstable: center of force has shifted showing clinically imbalanced forces across the dental arch

  2. Time taken to apply fixation device

    Time frame: Four to six weeks

Secondary outcomes

  1. Wire retightening frequency

    Time frame: Four to six weeks

  2. Soft tissue evaluation Gingival Index developed by Loe and Silness. The Gingival Index scores will be: 0 - Normal 1- Mild inflammation 2- Moderate inflammation 3 - Severe inflammation

    Time frame: Four to six weeks

    The Gingival Index scores will be:

    0 - Normal

    • Mild inflammation
    • Moderate inflammation 3 - Severe inflammation

  3. Patient acceptance and hardware tolerability (evaluated using Visual Analog Scale (VAS) VAS Scores: -Good: Minimal discomfort/pain -Fair: Moderate discomfort/pain -Poor: Significant discomfort/pain

    Time frame: Four to six weeks

    VAS Scores:

    • Good: Minimal discomfort/pain
    • Fair: Moderate discomfort/pain
    • Poor: Significant discomfort/pain

  4. Fracture union/non-union: assesed radiographically using cone beam computed tomography CBCT and Panoramic X-ray OPG.

    Time frame: Four to six weeks

    Radiographic assessment revealed:

    • Fracture Union: proper healing, with bone union.
    • Nonunion: failed healing, with no bone union.

  5. Complications (e.g., iatrogenic injuries, displacement, splaying)

    Time frame: Four to six weeks

  6. Gloves perforation incidence

    Time frame: Four to six weeks

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Evaluation of Erich Arch Bars, IMF Screws and Hybrid Arch Bars in the Management of Mandibular Fractures: A Randomized Clinical Study

Acronym: Jaw Fractures

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Apr 6, 2026

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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