Mandibular Fractures
Conditions
Keywords
Arch bars, Erich arch bars, Hybrid arch bars, Mandibular fractures, IMF Screws, MMF, IMF, Maxillomandibular Fixation, Jaw fractures, Maxillofacial Trauma, Mandibulomaxillary Fixation
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.
Interventions
DEVICEErich 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.
DEVICEHybrid 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
DEVICEIMF 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.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occlusal Stability/instability: clinically assessed (Chairside) | Four to six weeks | 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 taken to apply fixation device | Four to six weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The Gingival Index scores will be: 0 - Normal 1. Mild inflammation 2. Moderate inflammation 3 - Severe inflammation |
| Patient acceptance and hardware tolerability (evaluated using Visual Analog Scale (VAS) | Four to six weeks | VAS Scores: with 0 indicating the lowest level of acceptance and 100 the highest. |
| Fracture union/non-union: assesed radiographically using cone beam computed tomography CBCT and Panoramic X-ray OPG. | Four to six weeks | Radiographic assessment revealed: 1. Fracture Union: proper healing, with bone union. 2. Nonunion: failed healing, with no bone union. |
| Complications (e.g., iatrogenic injuries, displacement, splaying) | Four to six weeks | — |
| Gloves perforation incidence | Four to six weeks | — |
Countries
Egypt
Contacts
CONTACTZaid Alkurdy, MSc Candidate
CONTACTMansoura University Faculty of Dentistry, Mansoura University, Mansoura, Egypt
PRINCIPAL_INVESTIGATORFaculty of Dentistry, Mansoura University, Mansoura, Egypt
Faculty of Dentistry, Mansoura University, Mansoura, Egypt
Outcome results
None listed