Early Versus Late Intervention in Maxillofacial Trauma

NCT07749729 | Completed

• 1 other identifier: SUFODT2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Maxillofacial Trauma

Keywords

Maxillofacial trauma; Prospective cohort study

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after surgery

Secondary Outcomes (5)

• Radiological Bone Healing

  1, 3, and 6 months after surgery

• Percentage of Participants with Satisfactory Functional Recovery Based on Clinical Examination

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

• Percentage of Participants with Satisfactory Esthetic Outcome

  1 month, 3 months, and 6 months after surgery

• Incidence of Intraoperative Complications During ORIF

  During surgery

• Incidence of Postoperative Complications Following ORIF

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

Study Arms (2)

Early Intervention Group

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)

Delayed Intervention Group

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)

Interventions

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.

Delayed Intervention Group; Early Intervention Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haifa Mohammed Sharaf-Aldeen: lead

Study Sites (2)

Al-Gomhori Teaching Hospital

Sanaa, Amanat Al Asimah, Yemen

Location

Military Hospital

Sanaa, Amanat Al Asimah, Yemen

Location

MeSH Terms

Interventions

Fracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate in Oral and Maxillofacial Surgery, Faculty of Dentistry, Sana'a University

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 6, 2026
• Study Start: February 1, 2025
• Primary Completion: March 21, 2026
• Study Completion: March 21, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

YE (2)