An observational study in Maxillofacial Trauma, sponsored by Haifa Mohammed Sharaf-Aldeen. Completed at 2 sites in Yemen. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Haifa Mohammed Sharaf-Aldeen · Observational
Maxillofacial trauma represents a significant clinical challenge requiring timely surgical management. This prospective study aims to compare early versus delayed intervention in patients with maxillofacial trauma and evaluate the effects of treatment timing on functional, esthetic, and radiological outcomes.
Maxillofacial trauma is a major cause of functional impairment and facial deformity, often requiring surgical management with open reduction and internal fixation (ORIF). The timing of definitive surgical intervention remains controversial, particularly in resource-limited and conflict-affected settings where delays in treatment are common.
This prospective observational cohort study evaluates the effect of early (≤72 hours) versus delayed (>72 hours) ORIF on clinical outcomes in patients with maxillofacial fractures treated at Al-Gomhori Teaching Hospital and Military Hospital in Sana'a, Yemen.
Participants are allocated to cohorts according to the actual timing of definitive surgical treatment. The study investigates whether delayed intervention influences postoperative recovery, complication rates, functional rehabilitation, esthetic outcome, and radiographic fracture healing compared with early intervention.
Standardized surgical management and postoperative follow-up are performed according to the study protocol. Clinical and radiographic assessments are conducted during routine follow-up visits to evaluate healing and recovery over time. The findings are expected to provide evidence regarding the impact of treatment timing on outcomes of maxillofacial trauma and to support clinical decision-making in similar healthcare settings.
patients with maxillofacial fractures requiring open reduction and internal fixation (ORIF) who present to the participating governmental hospitals in Sana'a, Yemen. Participants will be enrolled prospectively and classified into early (≤72 hours) or delayed (>72 hours) intervention groups according to the timing of surgical treatment.
Exclusion Criteria:
Patients who underwent open reduction and internal fixation (ORIF) within 72 hours after maxillofacial trauma. This cohort includes patients receiving early surgical intervention following injury, according to the predefined study protocol.
Procedure: Timing of Open Reduction and Internal Fixation (ORIF)
Patients who underwent open reduction and internal fixation (ORIF) more than 72 hours after maxillofacial trauma. This cohort includes patients receiving delayed surgical intervention due to factors such as delayed presentation, associated injuries, logistical limitations, or other clinical considerations.
Procedure: Timing of Open Reduction and Internal Fixation (ORIF)
Comparison of early versus delayed open reduction and internal fixation (ORIF) in patients with maxillofacial trauma. Early intervention is defined as surgical management performed within 72 hours after injury, while delayed intervention is defined as surgical management performed more than 72 hours after injury. The study evaluates the impact of the timing of surgical intervention on clinical, functional, radiological, and aesthetic outcomes.
Percentage of Participants with Favorable Overall Clinical Outcome After ORIF
A favorable overall clinical outcome will be assessed using the study's standardized follow-up case sheet and clinical examination. The assessment includes wound healing, postoperative infection, fixation stability, functional recovery (maximum mouth opening, occlusion, mastication, temporomandibular joint function), neurological status, esthetic outcome (facial symmetry and scar appearance), and radiographic bone healing. Results will be reported as the percentage of participants achieving a favorable overall clinical outcome.
Time frame: 6 months after surgery
Radiological Bone Healing
Assessment of fracture healing following open reduction and internal fixation (ORIF) using panoramic radiography or computed tomography (CT) when clinically indicated. Bone healing will be evaluated based on radiographic evidence of fracture union.
Time frame: 1, 3, and 6 months after surgery
Percentage of Participants with Satisfactory Functional Recovery Based on Clinical Examination
Functional recovery will be assessed by standardized clinical examination using predefined categorical criteria recorded on the study follow-up case sheet. The assessment will include occlusion (normal or malocclusion), chewing efficiency (good, fair, or poor), maximum mouth opening (normal or limited), mandibular protrusive and lateral movements (normal or limited), temporomandibular joint dysfunction (present or absent), and ophthalmic complications (present or absent). Neurological function will be assessed clinically and categorized as none, partial, or complete paresthesia or nerve weakness. Results will be reported as the percentage of participants in each predefined functional outcome category.
Time frame: 48-72 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery
Percentage of Participants with Satisfactory Esthetic Outcome
The esthetic outcome will be assessed using the study's standardized follow-up case sheet and standardized clinical examination. Assessment will include facial symmetry (good, fair, or poor), scar appearance (normal, hypertrophic, or keloid), and depression of facial contour (none, mild, or severe). Results will be reported as the percentage of participants with satisfactory facial symmetry, normal scar appearance, and no clinically significant facial contour deformity.
Time frame: 1 month, 3 months, and 6 months after surgery
Incidence of Intraoperative Complications During ORIF
Intraoperative complications will be documented using the study operative case sheet. Complications include difficulty in soft tissue dissection, fracture reduction difficulty, fixation challenges, intraoperative contamination or infection, and the need for additional surgical procedures (e.g., bone grafting or soft tissue reconstruction). Results will be reported as the percentage of participants experiencing each intraoperative complication.
Time frame: During surgery
Incidence of Postoperative Complications Following ORIF
Postoperative complications will be assessed using the study's standardized follow-up case sheet and clinical examination. Complications include surgical site infection, wound dehiscence, hardware exposure or loosening, hardware removal, malocclusion, delayed union, malunion, non-union, facial asymmetry, sensory nerve deficit, and the need for revision surgery. Results will be reported as the percentage of participants experiencing each complication.
Time frame: 48-72 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery
Plan to share: No — Individual participant data will not be shared publicly or with external researchers due to ethical considerations, patient confidentiality requirements, and protection of personal health information. Aggregated results will be reported through peer-reviewed publications.
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