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

Not Applicable

Active, not recruiting

• Conditions: Mandibular Fractures

• Registration Number: NCT06883331
• Lead Sponsor: Suez Canal University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-27
• Primary Completion: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
radiographic evaluation	immediately postoperative	radiographic follow up of the patients immediate postoperatively with CBCT to assess the accuracy of IMF screws placement.; CBCT will be assessed to detect any injury to the roots of the teeth adjacent to the IMF screws as well as any injury to the adjacent vital structures

Secondary Outcome Measures

Name	Time	Method
clinical evaluation	intra-operative	clinical evaluation will be done intra-operatively to assess the time consumed in the study group compared to the control group

Trial Locations

Locations (1)

Suez Canal University; 🇪🇬 Ismailia, Egypt