Fixation of Fractures at Anterior Transition Zone Using Three Different Miniplates Configurations

NCT07058597 | Completed

• 1 other identifier: AMTZ-3G-2025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Fractures involving the anterior transition zone of the mandible are frequently encountered and hold particular clinical significance due to the presence of the mental nerve. Consequently, mental nerve paresthesia is among the common postoperative complications associated with these fractures. To assess the mental nerve functional integrity during fixation of fractures at the anterior transition zone using twin fork-miniplate, 3d interlocking miniplate and two miniplates

Conditions

Mandibular Fracture Trauma; Mandible Fracture

Keywords

mandibular fractures; anterior transition zone; mental nerve; electrophysiological study

Outcome Measures

Primary Outcomes (1)

• Sensory nerve function

  Objective assessment by using a dental probe pressure to determine any sensory changes along the distribution of the mental nerve in comparison to the contralateral side (nociceptive method).

  6 weeks

Secondary Outcomes (1)

• Radiographic evaluation for fracture healing

  3 months

Study Arms (3)

Patients with mandibular fracture in the anterior transition zone managed with Twinfork plate

ACTIVE COMPARATOR

Patients with mandibular fracture in the anterior transition zone managed with Twinfork plate

Device: Twinfork plate

Patients with mandibular fracture in the anterior transition zone managed with 3D-interlocking

ACTIVE COMPARATOR

Patients with mandibular fracture in the anterior transition zone managed with 3D-interlocking plate

Device: 3D-interlocking plate

Patients with mandibular fracture in the anterior transition zone managed with miniplates

EXPERIMENTAL

Patients with mandibular fracture in the anterior transition zone managed with miniplates

Device: Miniplate

Interventions

Twinfork plate DEVICE

Twinfork plate

Patients with mandibular fracture in the anterior transition zone managed with Twinfork plate

3D-interlocking plate DEVICE

3D-interlocking plate

Patients with mandibular fracture in the anterior transition zone managed with 3D-interlocking

Miniplate DEVICE

Miniplate

Patients with mandibular fracture in the anterior transition zone managed with miniplates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from recent, uninfected and minimally displaced or unfavorable fractures at parasymphysis-body region of the mandible
• Adult patients from 20-40 years old with no gender predilection that agreed to present for follow-up visits for a minimum postoperative period of 3 months.
• A fracture that demands open reduction and internal fixation.
• The patient medically fit for general anesthesia.

You may not qualify if:

• Medically compromised patients contradicting operation.
• Pathological fracture.
• An old fracture.
• Completely edentulous patient.
• Patients with frank infection.
• Patients with a comminuted fracture.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

Location

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: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Sequentially numbered, opaque, sealed envelopes (SNOSE) allocation concealment method will be utilized. Each participant included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each participant is allocated and placed inside opaque envelopes carrying the respective names of participants. A trial independent personnel will be assigned the role of keeping the envelopes and unfolding them only at the time of the operation, so that the participant is allocated to a group which is concealed from the operator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with with fractures in the anterior transition zone managed with 3 different configurations of miniplates

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: August 1, 2020
• Primary Completion: October 1, 2024
• Study Completion: February 1, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Access Criteria: to any one who required them after deidentification

Locations

EG (1)