Zygomatic FracturesNCT05695872
A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures
A study testing subtarsal approach, conventional transconjunctival approach and transconjunctival approach with Y- modification in people with Zygomatic Fractures, run by University of Alexandria at 1 site in Egypt.
Trial summary
The study is a randomized controlled clinical trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study is intended to compare between the subtarsal approach, conventional transconjuctival approach and the Y- modification of the transconjuctival approach in the management of… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Zygomatic Fractures
- What is being tested?
- subtarsal approach, conventional transconjunctival approach and transconjunctival approach with Y- modification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Aug 2022to 5 Feb 2023
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with ZMC fractures requiring open reduction and internal fixation.
- Adult patients aged between 20 and 50 years with no gender predilection.
Who cannot join
- An existing laceration in the inferior and lateral periorbital site.
- Infection at the fracture line.
- Comminuted fracture with bone loss.
- Acute and chronic conjunctival diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Best Approach to Zygomaticomaxillary Fractures: A Comparison of Three Surgical Approaches
The study is a randomized controlled clinical trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study is intended to compare between the subtarsal approach, conventional transconjuctival approach and the Y- modification of the transconjuctival approach in the management of zygomatico-maxillay complex fracture.
Read the detailed description
The study is a randomized controlled clinical trial. Twenty-four patients with age range of 20-50 years requiring open reduction and fixation of a fractured zygomatic complex were randomly divided into three equal groups according to the approach used:
Group A: subtarsal approach group. Group B: conventional transconjuctival approach group. Group C: Y- modification of the transconjuctival approach group.
- Conditions
- Zygomatic Fractures
- Being tested
- subtarsal approach, conventional transconjunctival approach, transconjunctival approach with Y- modification
- Medical subject headings
- Zygomatic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subtarsal approachProcedure or surgery
surgical approach
conventional transconjunctival approachProcedure or surgery
surgical approach
transconjunctival approach with Y- modificationProcedure or surgery
surgical approach
| Study group | Role | What they receive |
|---|---|---|
| subtarsal approach | Active comparator | Not described Receives: Procedure: subtarsal approach |
| conventional transconjunctival approach | Active comparator | Not described Receives: Procedure: conventional transconjunctival approach |
| transconjunctival approach with Y- modification | Active comparator | Not described Receives: Procedure: transconjunctival approach with Y- modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
accessibility to the fracture site
Adequate exposure provided by the incision and accessiblity to proper fracture reduction and fixation was assigned as Yes or No
Measured: intraoperative
esthetic appearance and scarring
Postoperative scarring was recorded as noticeable or unnoticeable
Measured: 6 weeks postoperative
radiographic verification of adequacy of fracture reduction
computed tomography was requested for adequacy of fracture reduction assessment and this outcome was assigned as Yes or No
Measured: immediate postoperative
Secondary outcomes (3)
The duration for exposure of the fracture site
The duration from performing the incision till the field exposure calculated in minutes
Measured: intraoperative
postoperative pain
Pain was evaluated at 24 hours and at 1 week according to a 10-point Visual Analogue Scale (VAS), (0-1=none,2-4=mild,5-7=moderate,8-10=severe).
Measured: at 24 hours and 1 week
sensory nerve function
Subjective assessment of the infraorbital nerve sensation by patient questioning about any alteration in sensation at 3 months postoperatively.
Objective assessment by dental probe pressure to assess sensory changes along the distribution of the infraorbital nerve with contralateral side comparison
Measured: 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start26 Aug 2022
- Primary completion1 Feb 2023
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Zygomatic FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia Nabil, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695872
- Sponsor's protocol ID
- UAlexandriaMaxFacSurg
- Status last verified
- May 2023
- First submitted
- 11 Jan 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melek LN, Noureldin MG. Zygomaticomaxillary complex fractures: finding the least complicated surgical approach (A Randomized Clinical Trial). BMC Oral Health. 2023 Aug 4;23(1):539. doi: 10.1186/s12903-023-03249-8.
PubMed 37542217
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Best Approach to Zygomaticomaxillary Fractures: A Comparison of Three Surgical Approaches
- ClinicalTrials.gov ID
- NCT05695872
- Acronym / sponsor ID
- UAlexandriaMaxFacSurg
- Conditions
- Zygomatic Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 25 Jan 2023 (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.
The study is a randomized controlled clinical trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study is intended to compare between the subtarsal approach, conventional transconjuctival approach and the Y- modification of the transconjuctival approach in the management of zygomatico-maxillay complex fracture.
Detailed description
The study is a randomized controlled clinical trial. Twenty-four patients with age range of 20-50 years requiring open reduction and fixation of a fractured zygomatic complex were randomly divided into three equal groups according to the approach used:
Group A: subtarsal approach group. Group B: conventional transconjuctival approach group. Group C: Y- modification of the transconjuctival approach group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| subtarsal approach | Active comparator | Procedure: subtarsal approach |
| conventional transconjunctival approach | Active comparator | Procedure: conventional transconjunctival approach |
| transconjunctival approach with Y- modification | Active comparator | Procedure: transconjunctival approach with Y- modification |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with ZMC fractures requiring open reduction and internal fixation.
- Adult patients aged between 20 and 50 years with no gender predilection.
Key exclusion criteria (4 listed)
- An existing laceration in the inferior and lateral periorbital site.
- Infection at the fracture line.
- Comminuted fracture with bone loss.
- Acute and chronic conjunctival diseases.
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 |
|---|---|---|
| subtarsal approachsurgical approach | Procedure or surgery | subtarsal approach |
| conventional transconjunctival approachsurgical approach | Procedure or surgery | conventional transconjunctival approach |
| transconjunctival approach with Y- modificationsurgical approach | Procedure or surgery | transconjunctival approach with Y- modification |
Primary outcome
accessibility to the fracture site
Time frame: intraoperative
Adequate exposure provided by the incision and accessiblity to proper fracture reduction and fixation was assigned as Yes or No
esthetic appearance and scarring
Time frame: 6 weeks postoperative
Postoperative scarring was recorded as noticeable or unnoticeable
radiographic verification of adequacy of fracture reduction
Time frame: immediate postoperative
computed tomography was requested for adequacy of fracture reduction assessment and this outcome was assigned as Yes or No
3 secondary outcomes
The duration for exposure of the fracture site
Time frame: intraoperative
postoperative pain
Time frame: at 24 hours and 1 week
sensory nerve function
Time frame: 3 months postoperative
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 9 May 2023.
- Derived from this study: PubMed 37542217Melek LN, Noureldin MG. Zygomaticomaxillary complex fractures: finding the least complicated surgical approach (A Randomized Clinical Trial). BMC Oral Health. 2023 Aug 4;23(1):539. doi: 10.1186/s12903-023-03249-8.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subtarsal approach, conventional transconjunctival approach and transconjunctival approach with Y- modification in people with Zygomatic Fractures, run by University of Alexandria at 1 site in Egypt.
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 2 inclusion and 4 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 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
accessibility to the fracture site (time frame: intraoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05695872, which also lists 1 linked publication.
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 9 May 2023.