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

NCT07153120 | Completed DMC

• 1 other identifier: MS.25.04.16
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Fractures

Keywords

Arch bars; Erich arch bars; Hybrid arch bars; Mandibular fractures; IMF Screws; MMF; IMF; Maxillomandibular Fixation; Jaw fractures; Maxillofacial Trauma; Mandibulomaxillary Fixation

Outcome Measures

Primary Outcomes (2)

• Occlusal Stability/instability: clinically assessed (Chairside)

  Stability categorizations: 1. Stable: center of force hasn't shifted showing clinically balanced forces across the dental arch 2. Unstable: center of force has shifted showing clinically imbalanced forces across the dental arch

  Four to six weeks

• Time taken to apply fixation device

  Four to six weeks

Secondary Outcomes (6)

• Wire retightening frequency

  Four to six weeks

• 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

  Four to six weeks

• 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

  Four to six weeks

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

  Four to six weeks

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

  Four to six weeks

Study Arms (3)

HAB Group

EXPERIMENTAL

Device: Hybrid Arch Bars

EAB Group

EXPERIMENTAL

Device: Erich Arch Bars

IMF Screws Group

EXPERIMENTAL

Device: IMF Screws

Interventions

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.

EAB Group

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

HAB Group

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.

IMF Screws Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Mandibular Fractures; Jaw Fractures

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical demonstrator at oral and maxillofacial surgery department, faculty of dentistry, Mansoura University, Mansoura University

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: January 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

EG (1)