3D Interlocking Miniplates in Fixation of Mandibular Fractures in the Mental Foramen Region: A Split-mouth Study

NCT06939010 | Completed Phase 4

• 1 other identifier: 3D-Interlocking
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

the study aims to compare 3D Interlocking miniplates with conventional miniplates in management of mandibular parasymphyseal fractures both clinically and radiographically.

Conditions

Mandibular Fractures; Miniplate

Keywords

Mental nerve; conventional miniplates; 3D Interlocking; mandibular parasymphyseal fracture

Outcome Measures

Primary Outcomes (1)

• Radiographic evaluation for the assessment of mean bone density at the fracture line

  Mean bone density at the fracture line was assessed using Cone-Beam Computed Tomography (CBCT) scan in Hounsfield Units (HU)

  12 weeks

Secondary Outcomes (1)

• Clinical evaluation for Intra-fragmentary mobility

  6 weeks

Study Arms (2)

patient with bilateral fracture in the mental nerve region managed with 3D-interlocking miniplate

EXPERIMENTAL

patient with bilateral fracture in the mental nerve region. one side will be randomly allocated to be managed with 3D-interlocking miniplate

Device: 3d-interlocking miniplate

patient with bilateral fracture in the mental nerve region managed with conventional miniplates

EXPERIMENTAL

patient with bilateral fracture in the mental nerve region. one side will be randomly allocated to be managed with conventional miniplates

Device: Conventional miniplates

Interventions

3d-interlocking miniplate DEVICE

3d-interlocking miniplate

patient with bilateral fracture in the mental nerve region managed with 3D-interlocking miniplate

Conventional miniplates DEVICE

double miniplates in the conventional configuration

patient with bilateral fracture in the mental nerve region managed with conventional miniplates

Eligibility Criteria

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

You may qualify if:

• patients with recent bilateral mandibular fracture located in the mental foramina region.
• adults without gender predilection who agreed to follow-up,
• fractures requiring open reduction and internal fixation, and
• those medically fit for general anesthesia were included

You may not qualify if:

• medically compromised patients,
• fractures with infection,
• pathological or old fractures,
• completely edentulous patients,
• comminuted fractures

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: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Fracture sides were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). Group A was treated with 3D-interlocking miniplate in one side, and Group B with conventional double miniplates configration in the other side.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split-mouth

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 22, 2025
• Study Start: January 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

EG (1)