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

NCT ID: NCT07153120

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-09-01

Brief Summary

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.

Detailed Description

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.

Conditions

Mandibular Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HAB Group

Group Type: EXPERIMENTAL

Hybrid Arch Bars

Intervention Type: 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

EAB Group

Group Type: EXPERIMENTAL

Erich Arch Bars

Intervention Type: 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.

IMF Screws Group

Group Type: EXPERIMENTAL

IMF Screws

Intervention Type: 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.

Interventions

Erich Arch Bars

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.

Intervention Type: DEVICE

Hybrid Arch Bars

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

Intervention Type: DEVICE

IMF Screws

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with mandibular fracture indicated for MMF. (Favorable fractures, minimally displaced).

2. Patients with an age range from 18:50 years old.

3. Patients free from any systemic diseases.

Exclusion Criteria

1. Patients that are not willing to participate in this clinical trial.

2. Edentulous patients or those with inadequate dentition for occlusal guidance

3. Pathological fractures.

4. Patients with absolute or relative contraindications to MMF (e.g. pregnancy, mental disorders and systemic diseases).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Zead Ahmad Khaled Murad Alkurdi

Clinical demonstrator at oral and maxillofacial surgery department, faculty of dentistry, Mansoura University, Mansoura University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mansoura University

Al Mansurah, , Egypt

Countries

Egypt

Facility Contacts

Zead Ahmad Alkurdi, Master's

Role: primary

zeadkurdi@std.mans.edu.eg

00201121326282

Other Identifiers

MS.25.04.16

Identifier Type: -

Identifier Source: org_study_id