Mandibular FracturesJaw FracturesNCT07153120
Erich Arch Bars, IMF Screws and Hybrid Arch Bars in the Management of Mandibular Fractures
A study testing Erich Arch Bars, Hybrid Arch Bars and IMF Screws in people with Mandibular Fractures, run by Mansoura University at 2 sites in Egypt.
Trial summary
Treatment options of mandibular fractures can be accomplished with either closed treatment or open reduction internal fixation (ORIF). Maxillomandibular fixation (MMF) refers to any method used to secure the maxilla and mandible in proper dental occlusion. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- Erich Arch Bars, Hybrid Arch Bars and IMF Screws
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesEgypt
- Study dates
- 16 Sep 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with mandibular fracture indicated for MMF. (Favorable fractures, minimally displaced).
- Patients with an age range from 18:50 years old.
- Patients free from any systemic diseases.
Who cannot join
- Patients that are not willing to participate in this clinical trial.
- Edentulous patients or those with inadequate dentition for occlusal guidance
- Pathological fractures.
- Patients with absolute or relative contraindications to MMF (e.g. pregnancy, mental disorders and systemic diseases).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mansoura University Faculty of Dentistry, Mansoura University, Mansoura, Egypt contact
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of Dentistry, Mansoura University
Al Mansurah, 35516
Nahed Ghoneim, roaanhf@mans.edu.eg
- Not yet recruiting
Mansoura University
Al Mansurah
Zead Ahmad Alkurdi, Master's, 00201121326282, zeadkurdi@std.mans.edu.eg
Zead Alkurdi, Master's
About this study
Official title: Evaluation of Erich Arch Bars, IMF Screws and Hybrid Arch Bars in the Management of Mandibular Fractures: A Randomized Clinical Study
Treatment options of mandibular fractures can be accomplished with either closed treatment or open reduction internal fixation (ORIF). Maxillomandibular fixation (MMF) refers to any method used to secure the maxilla and mandible in proper dental occlusion. MMF is a standard component of mandibular fracture management essential for closed treatment and commonly used du ring ORIF. Its three main principles are to establish occlusion, provide stability, and immobilize the jaws.
Read the detailed description
An abundance of modalities used for establishing MMF have been reported in the literature. Traditionally, Ivy eyelets wiring, Risdon wiring, metal splints, acrylic splints and Erich arch bars are used. Progressively, new techniques such as Intermaxillary Fixation (IMF) screws, wiring around single tooth with tight contacts, use of 2 miniplates, use of zip ties, use of bondable buttons and 2 looped wires have been developed to expedite securement of MMF.
The conventional MMF procedure uses arch bars of malleable strips of steel-bearing hooks, also known as Erich arch bars (EABs), allowing hands-free achievement and maintenance of excellent intraoperative occlusion with reproducibility.
However, the placement of Erich arch bars (EABs) fixated to the dentition with circumdental stainless-steel wires has been the standard practice for MMF for or during the repair of mandibular fractures for many decades.
Most of these techniques are limited in the setting of poor dentition or in patients who are partially edentulous, in addition of being time consuming, and are associated with risks of mucosal, dental, and needlestick injuries.
A hybrid arch bar (HAB) for MMF has been introduced to overcome some disadvantages of conventional arch bars. The HAB differs from the EAB because they are secured directly to the alveolar bone with screws rather than using teeth for anchorage.
Some authors suggest that IMF screws are less time consuming, provide better oral hygiene and reduce the risk of needle stick injury. Conversely, IMF screws have been associated with teeth root damage and screw loosening which can compromise MMF. Despite these disadvantages, IMF screws remain a recommended alternative to traditional arch bars for management of maxillofacial trauma.
- Conditions
- Mandibular Fractures
- Being tested
- Erich Arch Bars, Hybrid Arch Bars, IMF Screws
- Keywords
- Arch bars, Erich arch bars, Hybrid arch bars, Mandibular fractures, IMF Screws, MMF, IMF, Maxillomandibular Fixation, Jaw fractures, Maxillofacial Trauma, Mandibulomaxillary Fixation
- Medical subject headings
- Mandibular Fractures, Jaw Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erich Arch BarsDevice
Stainless steel plates with hooks for wire placement are adapted over the facial aspect of teeth so the wires would be inserted to go around the necks of teeth (circumdental wiring), then both maxillary and mandibular plates are ligated to each other in order to achieve MMF.
Hybrid Arch BarsDevice
Screw retained titanium plates with hooks for wires are adapted properly then self drilling self locking screws will be drilled in between roots of teeth to avoid injury, after fixation both jaws will be wired to accomplish MMF
IMF ScrewsDevice
A total of four self drilling screws two in the maxilla and the other two in the mandible will be inserted in the bone above and below teeth roots apices to avoid injury, to be ligated to each other in a vertical and an X pattern to achieve MMF.
| Study group | Role | What they receive |
|---|---|---|
| HAB Group | Experimental | Not described Receives: Device: Hybrid Arch Bars |
| EAB Group | Experimental | Not described Receives: Device: Erich Arch Bars |
| IMF Screws Group | Experimental | Not described Receives: Device: IMF Screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusal Stability/instability: clinically assessed (Chairside)
Stability categorizations:
- Stable: center of force hasn't shifted showing clinically balanced forces across the dental arch
- Unstable: center of force has shifted showing clinically imbalanced forces across the dental arch
Measured: Four to six weeks
Time taken to apply fixation device
Measured: Four to six weeks
Secondary outcomes (6)
Wire retightening frequency
Measured: Four to six weeks
Soft tissue evaluation Gingival Index developed by Loe and Silness. The Gingival Index scores will be: 0 - Normal 1- Mild inflammation 2- Moderate inflammation 3 - Severe inflammation
The Gingival Index scores will be:
0 - Normal
- Mild inflammation
- Moderate inflammation 3 - Severe inflammation
Measured: Four to six weeks
Patient acceptance and hardware tolerability (evaluated using Visual Analog Scale (VAS)
VAS Scores:
with 0 indicating the lowest level of acceptance and 100 the highest.
Measured: Four to six weeks
Fracture union/non-union: assesed radiographically using cone beam computed tomography CBCT and Panoramic X-ray OPG.
Radiographic assessment revealed:
- Fracture Union: proper healing, with bone union.
- Nonunion: failed healing, with no bone union.
Measured: Four to six weeks
Complications (e.g., iatrogenic injuries, displacement, splaying)
Measured: Four to six weeks
Gloves perforation incidence
Measured: Four to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start16 Sep 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zead Ahmad Alkurdi, Mansoura University
- Investigators
- Faculty of Dentistry, Mansoura University, Mansoura, Egypt, Principal investigator, Faculty of Dentistry, Mansoura University, Mansoura, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153120
- Sponsor's protocol ID
- MS.25.04.16
- Acronym
- Jaw Fractures
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Erich Arch Bars, IMF Screws and Hybrid Arch Bars in the Management of Mandibular Fractures: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07153120
- Acronym / sponsor ID
- Jaw Fractures / MS.25.04.16
- Conditions
- Mandibular Fractures
- Keywords
- Arch bars, Erich arch bars, Hybrid arch bars, Mandibular fractures, IMF Screws, MMF, IMF, Maxillomandibular Fixation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 3 Sep 2025 (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.
Treatment options of mandibular fractures can be accomplished with either closed treatment or open reduction internal fixation (ORIF). Maxillomandibular fixation (MMF) refers to any method used to secure the maxilla and mandible in proper dental occlusion. MMF is a standard component of mandibular fracture management essential for closed treatment and commonly used du ring ORIF. Its three main principles are to establish occlusion, provide stability, and immobilize the jaws.
Detailed description
An abundance of modalities used for establishing MMF have been reported in the literature. Traditionally, Ivy eyelets wiring, Risdon wiring, metal splints, acrylic splints and Erich arch bars are used. Progressively, new techniques such as Intermaxillary Fixation (IMF) screws, wiring around single tooth with tight contacts, use of 2 miniplates, use of zip ties, use of bondable buttons and 2 looped wires have been developed to expedite securement of MMF.
The conventional MMF procedure uses arch bars of malleable strips of steel-bearing hooks, also known as Erich arch bars (EABs), allowing hands-free achievement and maintenance of excellent intraoperative occlusion with reproducibility.
However, the placement of Erich arch bars (EABs) fixated to the dentition with circumdental stainless-steel wires has been the standard practice for MMF for or during the repair of mandibular fractures for many decades.
Most of these techniques are limited in the setting of poor dentition or in patients who are partially edentulous, in addition of being time consuming, and are associated with risks of mucosal, dental, and needlestick injuries.
A hybrid arch bar (HAB) for MMF has been introduced to overcome some disadvantages of conventional arch bars. The HAB differs from the EAB because they are secured directly to the alveolar bone with screws rather than using teeth for anchorage.
Some authors suggest that IMF screws are less time consuming, provide better oral hygiene and reduce the risk of needle stick injury. Conversely, IMF screws have been associated with teeth root damage and screw loosening which can compromise MMF. Despite these disadvantages, IMF screws remain a recommended alternative to traditional arch bars for management of maxillofacial trauma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HAB Group | Experimental | Device: Hybrid Arch Bars |
| EAB Group | Experimental | Device: Erich Arch Bars |
| IMF Screws Group | Experimental | Device: IMF Screws |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with mandibular fracture indicated for MMF. (Favorable fractures, minimally displaced).
- Patients with an age range from 18:50 years old.
- Patients free from any systemic diseases.
Key exclusion criteria (4 listed)
- Patients that are not willing to participate in this clinical trial.
- Edentulous patients or those with inadequate dentition for occlusal guidance
- Pathological fractures.
- Patients with absolute or relative contraindications to MMF (e.g. pregnancy, mental disorders and systemic 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 |
|---|---|---|
| Erich Arch BarsStainless steel plates with hooks for wire placement are adapted over the facial aspect of teeth so the wires would be inserted to go around the necks of teeth (circumdental wiring), then both maxillary and mandibular plates are ligated to each other in order to achieve MMF. | Device | EAB Group |
| Hybrid Arch BarsScrew retained titanium plates with hooks for wires are adapted properly then self drilling self locking screws will be drilled in between roots of teeth to avoid injury, after fixation both jaws will be wired to accomplish MMF | Device | HAB Group |
| IMF ScrewsA total of four self drilling screws two in the maxilla and the other two in the mandible will be inserted in the bone above and below teeth roots apices to avoid injury, to be ligated to each other in a vertical and an X pattern to achieve MMF. | Device | IMF Screws Group |
Primary outcome
Occlusal Stability/instability: clinically assessed (Chairside)
Time frame: Four to six weeks
Stability categorizations: 1. Stable: center of force hasn't shifted showing clinically balanced forces across the dental arch 2. Unstable: center of force has shifted showing clinically imbalanced forces across the dental arch
Time taken to apply fixation device
Time frame: Four to six weeks
6 secondary outcomes
Wire retightening frequency
Time frame: Four to six weeks
Soft tissue evaluation Gingival Index developed by Loe and Silness. The Gingival Index scores will be: 0 - Normal 1- Mild inflammation 2- Moderate inflammation 3 - Severe inflammation
Time frame: Four to six weeks
Patient acceptance and hardware tolerability (evaluated using Visual Analog Scale (VAS)
Time frame: Four to six weeks
Fracture union/non-union: assesed radiographically using cone beam computed tomography CBCT and Panoramic X-ray OPG.
Time frame: Four to six weeks
Complications (e.g., iatrogenic injuries, displacement, splaying)
Time frame: Four to six weeks
Gloves perforation incidence
Time frame: Four to six weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Mansoura University Faculty of Dentistry, Mansoura University, Mansoura, Egypt contact
Faculty of Dentistry, Mansoura University, Mansoura, Egypt principal investigator
Faculty of Dentistry, Mansoura University, Mansoura, Egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erich Arch Bars, Hybrid Arch Bars and IMF Screws in people with Mandibular Fractures, run by Mansoura University at 2 sites 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 3 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: looking for participants now, as of the sponsor's last update on 10 Sep 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zaid Alkurdy, MSc Candidate (+201121326282, ZeadKurdi@std.mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusal Stability/instability: clinically assessed (Chairside) (time frame: Four to six weeks). 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 10 Sep 2026.