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

NCT07094867 | Completed

• 1 other identifier: 0866-02/2024
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Fractures

Outcome Measures

Primary Outcomes (3)

• Change in pain scores

  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).

  after 24-hours, one week, four weeks and six weeks

• Presence of intra-fragmentary mobility

  The mobility assessed by bi-manual palpation across the fracture site.

  up to 6 weeks

• Change in bone density

  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

  baseline and 6 months

Secondary Outcomes (1)

• Change in sensory nerve function

  after 24-hours, one week, four weeks and six weeks

Study Arms (2)

Test Group "Customzied z Plate"

EXPERIMENTAL

Other: customized Z shaped miniplate

Conventional treatment "Miniplates"

ACTIVE COMPARATOR

Other: conventional two miniplates

Interventions

customized Z shaped miniplate OTHER

Planning was done using Mimics Innovation Suite 15.0 software for surgical planning, surgical simulation, and modeling of a custom-made Z-pattern plate installed on a standard personal computer system. The milling of a plate design on a titanium block was be done.

Test Group "Customzied z Plate"

conventional two miniplates OTHER

Mobilization of the fracture, removal of any soft tissue entrapped within the fracture line, and management of teeth in the fracture line, either by extraction or preservation. Followed by bone reduction into proper anatomical occlusion. Then conventional two miniplates was used according to Champy's osteosynthesis lines

Conventional treatment "Miniplates"

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Related Publications (1)

• Abd El Hamid MA, El Mahallawy AS, Elshatby NM, Saber ME. Customized z-shaped versus conventional miniplates for fixation of parasymphyseal/body mandibular fractures: a randomized controlled trial evaluating clinical and radiographic outcomes. BMC Oral Health. 2026 Feb 2. doi: 10.1186/s12903-026-07671-6. Online ahead of print.

  PMID: 41622154 DERIVED

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 30, 2025
• Study Start: April 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

EG (1)