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

Not Applicable

Not yet recruiting

• Conditions: Mandibular Fractures

• Registration Number: NCT07153120
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-08-26
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occlusal Stability (evaluated clinically)	Four to six weeks
Time taken to apply fixation device	Four to six weeks

Secondary Outcome Measures

Name	Time	Method
Wire retightening frequency	Four to six weeks
Soft tissue evaluation (oral hygiene scores using Gingival Index)	Four to six weeks
Patient acceptance and hardware tolerability (evaluated using Visual Analog Scale (VAS)	Four to six weeks
Fracture union (evaluated radiographically using CBCT and Panoramic radiographs).	Four to six weeks
Complications (e.g., iatrogenic injuries, displacement, splaying)	Four to six weeks
Gloves perforation incidence	Four to six weeks

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Al Mansurah, Egypt