Health TrialsbyHealthPanel

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

ConditionMandibular Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMansoura University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: HAB GroupExperimental treatment 1 intervention
Group B: EAB GroupExperimental treatment 1 intervention
Group C: IMF Screws GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Four to six weeks
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

The Gingival Index scores will be: 0 - Normal 1. Mild inflammation 2. Moderate inflammation 3 - Severe inflammation

Time frame
Four to six weeks
3

Patient acceptance and hardware tolerability (evaluated using Visual Analog Scale (VAS)

VAS Scores: with 0 indicating the lowest level of acceptance and 100 the highest.

Time frame
Four to six weeks
4

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

Radiographic assessment revealed: 1. Fracture Union: proper healing, with bone union. 2. Nonunion: failed healing, with no bone union.

Time frame
Four to six weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University

Lead sponsor

Source ClinicalTrials.gov
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