Z-shaped Miniplate Versus Conventional Two-miniplate Fixation of Symphyseal and Parasymphyseal Mandibular Fractures: a Prospective Comparative Study.
Sponsor study identifier
interventional
20
1 country
2
Study Start
September 25, 2025
Actual (reported)Primary Completion
February 15, 2026
Actual (reported)Study Completion
June 7, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 7, 2026
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 25, 2025
Actual (reported)February 15, 2026
Actual (reported)June 7, 2026
Actual (reported)October 22, 2026
Actual (reported)October 28, 2026
Actual (reported)Radiographic Evaluation of Fracture Reduction
Assessment of fracture reduction, hardware stability, and residual fracture gaps evaluated via computed tomography (CT) or panoramic radiography.
7 days and 3 months postoperatively.
Operative Time
Intraoperative
Postoperative Pain
Postoperative days 1, 2, and 7.
Facial Swelling
Postoperative days 1, 2, and 7.
Maximum Interincisal Opening (MIO) and Lateral Excursion
Postoperative days 1, 2, and 7.
Neurosensory Status
Postoperative days 1, 2, and 7.
Patients in this group undergo fixation of the mandibular fracture using a single Z-shaped titanium miniplate.
Patients in this group undergo fixation of the mandibular fracture using two conventional 5-hole non-compression 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.
Al-Gumhouri Teaching Hospital
Sanaa, Yemen
Al-Kuwait University Hospital
Sanaa, Yemen
Sam Da'er, Associate Professor
Sana'a University, Oral and Maxillofacial Surgery Department
Mostafeed Bajjash, MSc
Sana'a University, Oral and Maxillofacial Surgery Department
Mohammed Al-Maqaleh
Sana'a University, Oral and Maxillofacial Surgery Department
20 participants (actual enrollment reported by the registry).
First Submitted
October 22, 2026
First Posted
October 28, 2026
Study Start
September 25, 2025
Contact the study team to confirm eligibility.
Primary Completion
February 15, 2026
Actual (reported)Study Completion
June 7, 2026
Actual (reported)Last Updated
October 28, 2026
Record last verified: 2026-10
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.
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Source: ClinicalTrials.gov.
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