Early Versus Late Intervention in Maxillofacial Trauma | NCT07749729

NCT07749729

Overview

NCT ID: NCT07749729
Lead Sponsor: Haifa Mohammed Sharaf-AldeenOTHER
Official Title: Early Versus Late Intervention in Maxillofacial Trauma: A Comprehensive Prospective Study
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
Interventions: Timing of Open Reduction and Internal Fixation (ORIF)

Status and Timeline

Status: Completed
Last Update Posted: Aug 6, 2026Actual
Start Date: Feb 1, 2025Actual
Primary Completion Date: Mar 21, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 50Actual
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking

Contacts and Locations

Central Contacts: No data available
Locations: Al-Gomhori Teaching Hospital

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Participant Group/Arms

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)

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