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

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Miniplate; Mandibular Fractures

Treatments: Device: Conventional miniplates; Device: 3d-interlocking miniplate

Study type: Interventional

Funder types: Other

Identifiers

NCT06939010

3D-Interlocking

Details and patient eligibility

About

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

Full description

A total of 12 patients with recent bilateral parasymphyseal mandibular fractures were treated with 3D Interlocking miniplates on one side and with conventional two miniplates in the other side. Clinical evaluations were carried at multiple intervals up to 6 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Device: 3d-interlocking miniplate

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

Experimental group

Description:

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

Treatment:

Device: Conventional miniplates