Skip to main content
OpenTrials
Completed

NCT Number: NCT07749729

Early Versus Late Intervention in Maxillofacial Trauma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Maxillofacial Trauma

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Al-Gomhori Teaching Hospital, Sanaa, Amanat Al Asimah, Yemen

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 12 years and older.
  • Patients diagnosed with maxillofacial fractures requiring open reduction and internal fixation (ORIF).
  • Patients presenting with maxillofacial trauma treated within the participating study centers.
  • Patients assigned to either the early intervention group (≤72 hours after injury) or the delayed intervention group (>72 hours after injury).
  • Patients able to provide written informed consent or whose legally authorized representative provides consent when applicable.
  • Patients willing to comply with the scheduled follow-up visits. years and older.

Exclusion criteria

  • Patients managed with conservative (non-surgical) treatment.
  • Patients with previous maxillofacial fractures affecting the study site.
  • Patients with incomplete baseline clinical data.
  • Patients with severe medical conditions precluding surgical treatment or follow-up.
  • Patients lost to follow-up before completion of the primary outcome assessment.
  • Patients who decline to participate or withdraw informed consent.

Treatment and study plan

Timing of Open Reduction and Internal Fixation (ORIF)

Procedure

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.

Primary outcomes

  1. Percentage of Participants with Favorable Overall Clinical Outcome After ORIF

    Time frame: 6 months after surgery

    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.

Secondary outcomes

  1. Radiological Bone Healing

    Time frame: 1, 3, and 6 months after surgery

    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.

  2. Percentage of Participants with Satisfactory Functional Recovery Based on Clinical Examination

    Time frame: 48-72 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery

    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.

  3. Percentage of Participants with Satisfactory Esthetic Outcome

    Time frame: 1 month, 3 months, and 6 months after surgery

    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.

  4. Incidence of Intraoperative Complications During ORIF

    Time frame: During surgery

    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.

  5. Incidence of Postoperative Complications Following ORIF

    Time frame: 48-72 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery

    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.

Sponsors and collaborators

Lead sponsor

Haifa Mohammed Sharaf-Aldeen

Other

Registry information

Official study title

Early Versus Late Intervention in Maxillofacial Trauma: A Comprehensive Prospective Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.