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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Mandibular Fractures
• Intervention / Treatment: Procedure: intermaxillary fixation using IMF screws; Procedure: intermaxillary fixation using IMF screws with surgical guide

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt, 41522
    • Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IMF screws without surgical guide; control group: the patients will be treated without surgical guide, conventionally based on surgeon's clinical Experience.	Procedure: intermaxillary fixation using IMF screws; IMF screws will be placed at the junction of the attached and alveolar mucosa, after verifying the root position on the orthopantomogram (OPG) radiograph. One screw in each quadrant was sufficient; all IMF screws will be placed with the patient under local anesthesia or general anesthesia . Cortical perforation with a 1.5-mm drill bit under copious irrigation will be performed or by self-drilling IMF screws and the IMF screws will be tightened on the drilled hole. After IMFS placement, intraoperative IMF will be achieved by passing round, stainless steel wires through the screw head to achieve satisfactory occlusion.; Other Names: IMF
Experimental: IMF screws with a surgical guide; study group: the patients will be treated using Computer Assisted Surgical Guide to achieve accurate placement of IMF screws.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographic evaluation	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	immediately postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical evaluation	clinical evaluation will be done intra-operatively to assess the time consumed in the study group compared to the control group	intra-operative

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Study Director: Mohamed A Elsholkamy, professor, Suez Canal University; Study Director: Yasser N Helmy, Prof, Specialized Dental Hospital Kobry el Kobba Military Complex, Military Medical Academy; Principal Investigator: mohamed H Elsherbiny, Dr, Specialized Dental Hospital Kobry el Kobba Military Complex, Military Medical Academy

Publications and helpful links

General Publications

• Joseph Kamal. 2021. Computer Assisted Guided Placement of IMF Screws in Craniomaxillofacial Trauma: An Evolving Technique, Vol. 2(2) 170-173 DOI: 10.1177/27325016211008654 journals.sagepub.com/home/fac

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: fracture; fixation; mandible; screws
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Jaw Fractures; Maxillofacial Injuries; Skull Fractures; Fractures, Bone; Mandibular Fractures
• Other Study ID Numbers: 763/2024; Suez Canal University (ethtical committee of suez canal university)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No