CompletedNot Applicable

Early Versus Late Intervention in Maxillofacial Trauma

Yemen50 participantsStarted 2025-02-01

Plain-language 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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants with Favorable Overall Clinical Outcome After ORIF

Timeframe: 6 months after surgery

Trial details

NCT IDNCT07749729

SponsorHaifa Mohammed Sharaf-Aldeen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-21

View on ClinicalTrials.gov More Maxillofacial Trauma trials