An interventional study of Z-shaped titanium miniplate and Conventional titanium miniplates in Mandibular Fractures, sponsored by Sana'a University. Completed at 2 sites in Yemen. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Sana'a University · Not applicable, Interventional, and Treatment
This study compares two different methods of repairing fractures at the front of the lower jaw (the symphysis and parasymphysis). Usually, surgeons fix these displaced fractures using two separate titanium plates, which can be time-consuming to place and lie close to the nerve that supplies feeling to the lower lip and chin. Recently, a single Z-shaped titanium plate was designed to provide the same stability using less hardware, potentially making the surgery easier and safer for the nerve.
The purpose of this study is to compare the use of a single Z-shaped miniplate with the conventional two-miniplate technique in adult patients. The researchers will measure how long the surgery takes, the number of screws needed, and how easy it is to place the plates. After the surgery, patients will be monitored for up to 3 months to compare pain levels, facial swelling, jaw movement (mouth opening and side-to-side movement), nerve function, and how well the bone heals on x-rays.
The mandibular symphysis and parasymphysis are exposed to strong bending and twisting forces during function, meaning a single conventional miniplate is usually insufficient to neutralize forces and prevent the inner surface of the bone from opening under muscle pull. The accepted standard for semirigid fixation is two miniplates. However, this technique requires wider surgical exposure, separate contouring of two plates, and carries a risk of nerve injury due to the proximity of the mental foramen. While closed three-dimensional (3D) plates offer cross-bracing with a single implant, they can be difficult to adapt around the mental nerve. The Z-shaped miniplate features two parallel bars joined by an oblique bar; its open edges allow placement without trapping the nerve.
This prospective, quasi-randomised comparative study is conducted at Al-Kuwait University Hospital and Al-Gumhouri Teaching Hospital in Sana'a, Yemen. It aims to evaluate the operative, clinical, and radiographic outcomes of a single Z-shaped miniplate versus two conventional miniplates. Patients undergo open reduction and internal fixation under general anesthesia using a standardized surgical protocol. Clinical follow-up is conducted on postoperative days 1, 2, and 7 to assess pain via visual analogue scale, facial swelling via linear tape measurements, maximum interincisal opening, lateral excursion, and neurosensory status. Radiographic reduction and residual fracture gaps are evaluated via computed tomography or panoramic radiography at 7 days and 3 months postoperatively.
91 studies on the registry are indexed under Mandibular Fractures; 24 are open to participants now.
This study's enrollment of 20 is close to the median of 21 across 72 interventional studies indexed under Mandibular Fractures.
Browse Mandibular Fractures studies →Sana'a University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Patients in this group undergo fixation of the mandibular fracture using a single Z-shaped titanium miniplate.
Device: Z-shaped titanium miniplate
Patients in this group undergo fixation of the mandibular fracture using two conventional 5-hole non-compression titanium miniplates.
Device: Conventional titanium miniplates
Open reduction and internal fixation of the mandibular fracture using a single Z-shaped titanium miniplate
Open reduction and internal fixation of the mandibular fracture using two 5-hole non-compression titanium miniplates.
Radiographic Evaluation of Fracture Reduction
Assessment of fracture reduction, hardware stability, and residual fracture gaps evaluated via computed tomography (CT) or panoramic radiography.
Time frame: 7 days and 3 months postoperatively.
Operative Time
The total surgical time required for plate adaptation, placement, and screw fixation, measured in minutes.
Time frame: Intraoperative
Postoperative Pain
Patient-reported pain intensity assessed using a standard Visual Analogue Scale (VAS).
Time frame: Postoperative days 1, 2, and 7.
Facial Swelling
Postoperative edema evaluated using objective linear tape measurements between standard facial landmarks.
Time frame: Postoperative days 1, 2, and 7.
Maximum Interincisal Opening (MIO) and Lateral Excursion
Measurement of maximum mouth opening and side-to-side jaw movement in millimeters to assess functional recovery.
Time frame: Postoperative days 1, 2, and 7.
Neurosensory Status
Clinical assessment of the mental nerve function (e.g., using light touch or pinprick testing) to evaluate for potential iatrogenic nerve injury.
Time frame: Postoperative days 1, 2, and 7.
Plan to share: No — Individual participant data will not be shared to protect patient confidentiality and privacy. All relevant data supporting the findings and conclusions of this study will be made available in aggregate form within the published manuscript and its supplementary materials.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Sana'a University