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

Mansoura University

Status: Not yet enrolling

Conditions: Mandibular Fractures

Treatments: Device: Hybrid Arch Bars; Device: Erich Arch Bars; Device: IMF Screws

Study type: Interventional

Funder types: Other

Identifiers

NCT07153120

MS.25.04.16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups

HAB Group

Experimental group

Treatment:

Device: Hybrid Arch Bars

EAB Group

Experimental group

Treatment:

Device: Erich Arch Bars

IMF Screws Group

Experimental group

Treatment:

Device: IMF Screws