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

NCT06883331 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-19

No results posted yet for this study

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

Conditions

  • Mandibular Fractures

Interventions

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.

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

Sponsors & Collaborators

  • Suez Canal University

    lead OTHER

Principal Investigators

  • Mohamed A Elsholkamy, Professor · Suez Canal University

  • Yasser N Helmy, Prof · Specialized Dental Hospital Kobry el Kobba Military Complex, Military Medical Academy

  • mohamed H Elsherbiny, Dr · Specialized Dental Hospital Kobry el Kobba Military Complex, Military Medical Academy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-27
Primary Completion
2025-03-31
Completion
2025-04-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06883331 on ClinicalTrials.gov