Customized z Shaped Miniplate Versus Standard 2 Miniplates for Fixation of Parasymphyseal/Body Mandibular Fractures

Not Applicable

Completed

• Conditions: Mandibular Fractures

• Registration Number: NCT07094867
• Lead Sponsor: Hams Hamed Abdelrahman

Brief Summary

Mandibular fractures are a common type of facial fractures. The surgical treatment has developed over the years due to improved understanding of biomechanics, biomaterials and scientifically based treatment outcomes. since customized fixation mechanism is more suited to the bone surface which helps to meet the requirements of a semirigid fixation. Customized Z plate is a new geometry of miniplates that may provide superior preservation of mental nerve, stability, support and easier in adaptation compared to the standard 2 miniplates system for fixation of parasymhyseal/body mandibular fractures.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30
• Study First Submitted: 2025-06-27
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-23
• Last Update Submitted: 2025-07-23
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Patients suffering from recent fractures at the parasymphysis/body of the mandible presented within 2 weeks of the date of trauma.
• Radiographic evidence of parasymphyseal/body mandibular fracture that demands open reduction and internal fixation.
• The patient is medically fit for general anesthesia

Exclusion Criteria

• comminuted fracture.
• Pathological fracture.
• Presence of infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Presence of intra-fragmentary mobility	up to 6 weeks	The mobility assessed by bi-manual palpation across the fracture site.
Change in bone density	baseline and 6 months	Immediate CBCT scan will be used to assess the adequacy of fracture line reduction and fixation, and then another will be taken at 6th month to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan
Change in pain scores	after 24-hours, one week, four weeks and six weeks	Patient asked to identify his pain sensation through a 10-point visual analogue scale (VAS) and the level of pain will be interpreted as (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).

Secondary Outcome Measures

Name	Time	Method
Change in sensory nerve function	after 24-hours, one week, four weeks and six weeks	Presecne of alteration in sensation in lower lip and mental area (Yes/No)

Trial Locations

Locations (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt