Maxillofacial TraumaNCT07749729
Early Versus Late Intervention in Maxillofacial Trauma
An observational study of Maxillofacial Trauma, run by Haifa Mohammed Sharaf-Aldeen at 2 sites in Yemen.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Maxillofacial Trauma
- What is being tested?
- Timing of Open Reduction and Internal Fixation (ORIF)
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesYemen
- Study dates
- 1 Feb 2025to 21 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Yemen2 sites
Al-Gomhori Teaching Hospital
Sanaa, Amanat Al Asimah
Military Hospital
Sanaa, Amanat Al Asimah
About this study
Official title: Early Versus Late Intervention in Maxillofacial Trauma: A Comprehensive Prospective Study
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.
Read the detailed description
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.
- Conditions
- Maxillofacial Trauma
- Being tested
- Timing of Open Reduction and Internal Fixation (ORIF)
- Keywords
- Maxillofacial trauma, Prospective cohort study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of Open Reduction and Internal Fixation (ORIF)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Timing of Open Reduction and Internal Fixation (ORIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 48-72 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Feb 2025
- Primary completion21 Mar 2026
- Study completion21 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haifa Mohammed Sharaf-Aldeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haifa Mohammed Sharaf-Aldeen, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749729
- Sponsor's protocol ID
- SUFODT2025
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Intervention in Maxillofacial Trauma: A Comprehensive Prospective Study
- ClinicalTrials.gov ID
- NCT07749729
- Acronym / sponsor ID
- SUFODT2025
- Conditions
- Maxillofacial Trauma
- Keywords
- Maxillofacial trauma, Prospective cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Haifa Mohammed Sharaf-AldeenUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 21 Mar 2026 (actual)
- Study completion
- 21 Mar 2026 (actual)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Intervention Group | – | Procedure: Timing of Open Reduction and Internal Fixation (ORIF)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. |
| Delayed Intervention Group | – | 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Delayed Intervention Group, Early Intervention Group |
Primary outcome
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.
5 secondary outcomes
Radiological Bone Healing
Time frame: 1, 3, and 6 months after surgery
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
Percentage of Participants with Satisfactory Esthetic Outcome
Time frame: 1 month, 3 months, and 6 months after surgery
Incidence of Intraoperative Complications During ORIF
Time frame: During surgery
Incidence of Postoperative Complications Following ORIF
Time frame: 48-72 hours, 2 weeks, 1 month, 3 months, and 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillofacial Trauma, run by Haifa Mohammed Sharaf-Aldeen at 2 sites in Yemen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Favorable Overall Clinical Outcome After ORIF (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.