An interventional study of Erich Arch Bars and Hybrid Arch Bars in Mandibular Fractures, sponsored by Mansoura University. Recruiting at 2 sites in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
Among 42 studies in Mandibular Fractures with a site in Egypt — 8 open to participants now, 11 under way, none of them phase 3. Mandibular Fractures · Egypt.
Among the 42 studies in Mandibular Fractures with a site in Egypt, this one has the largest planned enrollment of the 38 interventional ones, is one of 8 that started in 2025, is one of 35 with no phase, reaches primary completion later than 7 of the 10 other live ones, and was the 26th registered.
91 studies on the registry are indexed under Mandibular Fractures; 24 are open to participants now.
This study's planned enrollment of 105 is above the median of 21 across 72 interventional studies indexed under Mandibular Fractures.
Browse Mandibular Fractures studies →8 of the 42 studies in Mandibular Fractures with a site in Egypt are open now, in 1 country. Each count lists the studies.
Of the 11 Mandibular Fractures studies recruiting now, 2 (18%) set no upper age limit and 9 (82%) stop at 75 or younger; 1 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · no healthy volunteers.
The full table on the hub →42 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 8 started in 2025.
Median enrollment 20 across the 38 interventional studies, 43 across the 4 observational. Of the 24 that completed or were terminated, 0 (0%) have results posted.
None of the 42 has an industry lead sponsor. The 10 most frequent:
Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Mansoura University has 4 studies filed under Mandibular Fractures — fewer than ten, so there is no comparison to draw.
6 of the studies in Mandibular Fractures with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07807813Delta University for Science and TechnologySafety-zone Approach and Facial Nerve Preservation in Transbuccal-accessed Fixation of Mandibular Fractures | 2026-11 |
| NCT07263893Suez Canal UniversityInter Flex Three Dimensional Plate in Management of Mandibular Fracture RCT | 2026-12-01 |
| NCT07153120Mansoura UniversityErich Arch Bars, IMF Screws and Hybrid Arch Bars in the Management of Mandibular Fractures | 2027-02 |
| NCT07850570Mansoura UniversityCustom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates | 2027-03-24 |
| NCT07515937Cairo UniversityOcclusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series | 2027-07 |
Among the 42 studies in Mandibular Fractures with a site in Egypt, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Hybrid Arch Bars
Device: Erich Arch Bars
Device: IMF Screws
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.
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
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.
Occlusal Stability/instability: clinically assessed (Chairside)
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 frame: Four to six weeks
Time taken to apply fixation device
Time frame: Four to six weeks
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
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)
VAS Scores: with 0 indicating the lowest level of acceptance and 100 the highest.
Time frame: Four to six weeks
Fracture union/non-union: assesed radiographically using cone beam computed tomography CBCT and Panoramic X-ray OPG.
Radiographic assessment revealed: 1. Fracture Union: proper healing, with bone union. 2. Nonunion: failed healing, with no bone union.
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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Feb 2027, 17 months after the start.
Of 38 non-industry interventional studies with no phase under Mandibular Fractures, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's planned 17 months is above that.
Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 9 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
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