Mandibular Fracture TraumaNCT07860853
Clinical and Radiographic Study of Erich Arch Bar Versus Embrasure Wire for Intermaxillary Fixation in Management of Mandibular Fractures
A study testing Intermaxillary fixation in people with Mandibular Fracture Trauma, run by Suez Canal University at 1 site in Egypt.
Trial summary
comparing between two methods of intermaxillary fixation for mandibular fracture which is erich arch bar and embrasure wires in management of mandibular fracture comparing the time consumed in General anathesia and how the embrasure wires decreased the time of GA into half with providing a respected stability during… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Fracture Trauma
- What is being tested?
- Intermaxillary fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Oct 2022to 27 Nov 2024
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient with symphseal, parasymphseal, body and angle mandibular fractures
- Patient indicated for G A surgery
- The patients between the age of 18 and 40
- Simple linear mandibular fracture
- Minimally, moderately or severly displaced mandibular fracture
- Patients with accessible interdental spaces
Who cannot join
- Edentulous patients
- Patients with primary and mixed dentition
- Pathologic mandibular fracture
- Patient with gunshot injuries
- Patient with gross generalized spacing in dentition
- Patient with unilateral or bilateral mandibular condylar fracture
- Patient with gross dental mobility
Trial locations and contacts
1 site in 1 country.
About this study
comparing between two methods of intermaxillary fixation for mandibular fracture which is erich arch bar and embrasure wires in management of mandibular fracture comparing the time consumed in General anathesia and how the embrasure wires decreased the time of GA into half with providing a respected stability during fixation and how it more safe for the surgeons and patient as it decrease:
- the risk of gloves perforation during surgery
- decreasing the risk of wire injuries
- decreasing blood borne transmission diseases
- decreasing iatrogenic injuries for patient such as tooth avulsion or frature / injuries to interdental papilla / tooth mobility
- Conditions
- Mandibular Fracture Trauma
- Being tested
- Intermaxillary fixation
- Keywords
- ORIF, embrassure wire, erich arch bar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermaxillary fixationDevice
Also called IMF, Maxillomandibular fixation
It means fixation of maxilla and mandible during mangement of mandibular fracture using a erich arch bar (Hu-freidy, USA) and a prestretched 26 gauge wire (Leone, Italy) or using Embrassure wires (Leone, Italy) to restore the normal occulsion and function for the patient before mandibular reduction and fixation
| Study group | Role | What they receive |
|---|---|---|
| Erich arch bar for intermaxillary fixation in management of mandibular fracture | Experimental | Erich arch bar ( Hu-Friedy, USA) was used. A prefabricated arch bar with hooks incorporated on the outer surface with flat malleable stainless steel metal strip was cut accurately to the length of both upper and lower dental arches. On the upper jaw, the hooks were arranged in an upward direction and to the lower jaw in a downward direction. The arch bar was adapted to the buccal surface from 1st molar to 1st molar in both arches. It was fixed to each tooth, using prestretched 26- gauge stainless steel wire (Leone, Italy) , which is passed from the mesial surface of teeth to the lingual side and back on the buccal side from the distal surface of the tooth, making sure that one end of the wire is passing above the arch bar and the other below it. After this, both ends of the wire were twisted together in a clockwise manner and the arch bar was attached securely and firmly to the necks of each tooth on the buccal surface of the arch Receives: Device: Intermaxillary fixation |
| Embrassure wires for intermaxillary fixation in management of mandibular fracture | Experimental | single prestretched 22-gauge wire (leone, Italy) of 15-cm length was passed through the facial embrasure between maxillary first molar and second premolar, and then, the palatal end of the wire was looped and passed through the opposite lingual embrasure in the mandible. Similar procedure was repeated on the contralateral side to achieve intermaxillary fixation. After achieving the occlusion, the ends of the wire were twisted together on the buccal surface of the lower premolar and molar teeth on both sides and intermaxillary fixation was achieved Receives: Device: Intermaxillary fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
injury to operator for each patient
comparing injuries to operators such as wire stick injuries and incidence of gloves perforations ( direct seen by single observer or indirect through water inflation method )
Measured: intraopertively (During surgery)
time taken for application of each technique
comparing the time taken ( in minutes) for fixation of erich arch bar with time taken for embrassure wires intraopertively to determine which technique more faster and stable than other
Measured: during surgery ( intraopertively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start11 Oct 2022
- Primary completion28 Oct 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Fracture TraumaStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860853
- Sponsor's protocol ID
- 607/2023
- Other IDs
- suez canal university
- Status last verified
- Oct 2024
- First submitted
- 20 Jan 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Study of Erich Arch Bar Versus Embrasure Wire for Intermaxillary Fixation in Management of Mandibular Fractures
- ClinicalTrials.gov ID
- NCT07860853
- Acronym / sponsor ID
- 607/2023
- Conditions
- Mandibular Fracture Trauma
- Keywords
- ORIF, embrassure wire, erich arch bar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 6 Oct 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.
comparing between two methods of intermaxillary fixation for mandibular fracture which is erich arch bar and embrasure wires in management of mandibular fracture comparing the time consumed in General anathesia and how the embrasure wires decreased the time of GA into half with providing a respected stability during fixation and how it more safe for the surgeons and patient as it decrease:
- the risk of gloves perforation during surgery
- decreasing the risk of wire injuries
- decreasing blood borne transmission diseases
- decreasing iatrogenic injuries for patient such as tooth avulsion or frature / injuries to interdental papilla / tooth mobility
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erich arch bar for intermaxillary fixation in management of mandibular fracture | Experimental | Device: Intermaxillary fixationErich arch bar ( Hu-Friedy, USA) was used. A prefabricated arch bar with hooks incorporated on the outer surface with flat malleable stainless steel metal strip was cut accurately to the length of both upper and lower dental arches. On the upper jaw, the hooks were arranged in an upward direction and to the lower jaw in a downward direction. The arch bar was adapted to the buccal surface from 1st molar to 1st molar in both arches. It was fixed to each tooth, using prestretched 26- gauge stainless steel wire (Leone, Italy) , which is passed from the mesial surface of teeth to the lingual side and back on the buccal side from the distal surface of the tooth, making sure that one end of the wire is passing above the arch bar and the other below it. After this, both ends of the wire were twisted together in a clockwise manner and the arch bar was attached securely and firmly to the necks of each tooth on the buccal surface of the arch |
| Embrassure wires for intermaxillary fixation in management of mandibular fracture | Experimental | Device: Intermaxillary fixationsingle prestretched 22-gauge wire (leone, Italy) of 15-cm length was passed through the facial embrasure between maxillary first molar and second premolar, and then, the palatal end of the wire was looped and passed through the opposite lingual embrasure in the mandible. Similar procedure was repeated on the contralateral side to achieve intermaxillary fixation. After achieving the occlusion, the ends of the wire were twisted together on the buccal surface of the lower premolar and molar teeth on both sides and intermaxillary fixation was achieved |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient with symphseal, parasymphseal, body and angle mandibular fractures
- Patient indicated for G A surgery
- The patients between the age of 18 and 40
- Simple linear mandibular fracture
- Minimally, moderately or severly displaced mandibular fracture
Key exclusion criteria (7 listed)
- Edentulous patients
- Patients with primary and mixed dentition
- Pathologic mandibular fracture
- Patient with gunshot injuries
- Patient with gross generalized spacing in dentition
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 |
|---|---|---|
| Intermaxillary fixationAlso: IMF, Maxillomandibular fixationIt means fixation of maxilla and mandible during mangement of mandibular fracture using a erich arch bar (Hu-freidy, USA) and a prestretched 26 gauge wire (Leone, Italy) or using Embrassure wires (Leone, Italy) to restore the normal occulsion and function for the patient before mandibular reduction and fixation | Device | Embrassure wires for intermaxillary fixation in management of mandibular fracture, Erich arch bar for intermaxillary fixation in management of mandibular fracture |
Primary outcome
injury to operator for each patient
Time frame: intraopertively (During surgery)
comparing injuries to operators such as wire stick injuries and incidence of gloves perforations ( direct seen by single observer or indirect through water inflation method )
time taken for application of each technique
Time frame: during surgery ( intraopertively)
comparing the time taken ( in minutes) for fixation of erich arch bar with time taken for embrassure wires intraopertively to determine which technique more faster and stable than other
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 Oct 2026.
- Individual participant dataSharing planned: Yes
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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 Intermaxillary fixation in people with Mandibular Fracture Trauma, run by Suez Canal University 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 6 inclusion and 7 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 Oct 2026. 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?
injury to operator for each patient (time frame: intraopertively (During surgery)). The study lists 2 primary outcomes in all. 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 Oct 2026.