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

NCT ID: NCT06883331

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-27
• Study Completion Date: 2025-04-30

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.

Conditions

Mandibular Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IMF screws without surgical guide

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

Group Type: ACTIVE_COMPARATOR

intermaxillary fixation using IMF screws

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

intermaxillary fixation using IMF screws with surgical guide

The patient's CBCT images in DICOM format will be converted into stereolithographic (STL) images using the segmentation software.

The converted CBCT STL images will be integrated to obtain the exact tooth morphology Virtual surgical planning (VSP) will be carried out using software to select the exact position of IMF screws placement away from any vital, anatomical or tooth structure.

these locations will be incorporated into the patients specific IMF surgical guides as access holes to direct the IMF screws drill.

Guide will be constructed with a thickness of 2-3 mm and printed using Photopolymer Resin® (Form labs) in the CAD/CAM 3- dimensional (3D) printer

Intervention Type: PROCEDURE

Other Intervention Names

IMF

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed A Elsholkamy, Professor

Role: STUDY_DIRECTOR

Suez Canal University

Yasser N Helmy, Prof

Role: STUDY_DIRECTOR

Specialized Dental Hospital Kobry el Kobba Military Complex, Military Medical Academy

mohamed H Elsherbiny, Dr

Role: PRINCIPAL_INVESTIGATOR

Specialized Dental Hospital Kobry el Kobba Military Complex, Military Medical Academy

Locations

Suez Canal University

Ismailia, , Egypt

Countries

Egypt

References

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

Reference Type: BACKGROUND

Other Identifiers

Suez Canal University

Identifier Type: OTHER

Identifier Source: secondary_id

763/2024

Identifier Type: -

Identifier Source: org_study_id