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Mandibular fractures are a common type of facial fractures. The surgical treatment has developed over the years due to improved understanding of biomechanics, biomaterials and scientifically based treatment outcomes. since customized fixation mechanism is more suited to the bone surface which helps to meet the requirements of a semirigid fixation. Customized Z plate is a new geometry of miniplates that may provide superior preservation of mental nerve, stability, support and easier in adaptation compared to the standard 2 miniplates system for fixation of parasymhyseal/body mandibular fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group "Customzied z Plate" | Experimental |
| |
| Conventional treatment "Miniplates" | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| customized Z shaped miniplate | Other | Planning was done using Mimics Innovation Suite 15.0 software for surgical planning, surgical simulation, and modeling of a custom-made Z-pattern plate installed on a standard personal computer system. The milling of a plate design on a titanium block was be done. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain scores | Patient asked to identify his pain sensation through a 10-point visual analogue scale (VAS) and the level of pain will be interpreted as (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe). | after 24-hours, one week, four weeks and six weeks |
| Presence of intra-fragmentary mobility | The mobility assessed by bi-manual palpation across the fracture site. | up to 6 weeks |
| Change in bone density | Immediate CBCT scan will be used to assess the adequacy of fracture line reduction and fixation, and then another will be taken at 6th month to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sensory nerve function | Presecne of alteration in sensation in lower lip and mental area (Yes/No) | after 24-hours, one week, four weeks and six weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42151958 | Derived | Abd El Hamid MA, El Mahallawy AS, Saber ME. Accuracy of reduction and postoperative symmetry assessment of customized z-shaped miniplates versus conventional miniplates in mandibular fractures treatment: a randomized controlled clinical trial. BMC Oral Health. 2026 May 18;26(1):906. doi: 10.1186/s12903-026-08555-5. | |
| 41622154 | Derived |
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| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
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|
| conventional two miniplates | Other | Mobilization of the fracture, removal of any soft tissue entrapped within the fracture line, and management of teeth in the fracture line, either by extraction or preservation. Followed by bone reduction into proper anatomical occlusion. Then conventional two miniplates was used according to Champy's osteosynthesis lines |
|
| Abd El Hamid MA, El Mahallawy AS, Elshatby NM, Saber ME. Customized z-shaped versus conventional miniplates for fixation of parasymphyseal/body mandibular fractures: a randomized controlled trial evaluating clinical and radiographic outcomes. BMC Oral Health. 2026 Feb 2;26(1):415. doi: 10.1186/s12903-026-07671-6. |
| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |