Validity of Computed Guided Technology in Proper Placement of Intermaxillary Fixation Screws in Mandibular Fractures

Suez Canal University

Status: Active, not recruiting

Conditions: Mandibular Fractures

Treatments: Procedure: intermaxillary fixation using IMF screws with surgical guide; Procedure: intermaxillary fixation using IMF screws

Study type: Interventional

Funder types: Other

Identifiers

NCT06883331

763/2024

Suez Canal University (Registry Identifier)

Details and patient eligibility

About

A randomized clinical study that aims to assess the validity of the use of computer guided technique in the proper placement of IMF screws in mandibular fractures

Full description

Fractures of the facial skeleton involving the teeth bearing segments can lead to disruption of the dental occlusion, and difficulties with speech and mastication. The temporary fixation of opposing jaws is called maxillomandibular fixation and is usually secured through placement of IMF screws and wires. The correct placement of IMF screws can be challenging. Such planning may make use of radiographs and computed tomography scans. Knowledge of safe zones in the facial skeleton for screw placement through the use of pre-operative 3-dimensional planning may prevent some of the cited complications. The use of a custom made surgical guide for IMF screw placement has the potential to reduce operation time, optimize screw position, and minimize injury to dental roots and important anatomical structures. Aim: The aim of this study is to Assess the use of computed guided technique in the proper placement of IMF screws in mandibular fractures. Materials and Methods: This clinical study will be conducted on 20 patients who will be equally and randomly distributed into 2 groups: Group A: 10 patients will be treated with 3D guided placement of IMF screw. Group B: 10 patients will be treated with Conventional placement of IMF screws.

To assess the accuracy of IMF screws placement in each group.

Enrollment: 20 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffer from recent mandibular fractures that requires fixation
• Dentulous patients
• Medically fit for surgery (ASA I AND ASA II)

Exclusion criteria

• Edentulous patients
• Patient with bone pathosis
• patients with primary and mixed dentition
• pathologic mandibular fracture

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

IMF screws without surgical guide

Active Comparator group

Description:

control group: the patients will be treated without surgical guide, conventionally based on surgeon's clinical Experience.

Treatment:

Procedure: intermaxillary fixation using IMF screws

IMF screws with a surgical guide

Experimental group

Description:

study group: the patients will be treated using Computer Assisted Surgical Guide to achieve accurate placement of IMF screws.