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

NCT06883331 | Active Not Recruiting DMC

• 2 other identifiers: 763/2024Suez Canal University
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Mandibular Fractures

Keywords

mandible; fracture; fixation; screws

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• clinical evaluation

  intra-operative

Study Arms (2)

IMF screws without surgical guide

ACTIVE COMPARATOR

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 with a surgical guide

EXPERIMENTAL

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

Interventions

intermaxillary fixation using IMF screws 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.

Also known as: IMF

IMF screws without surgical guide

intermaxillary fixation using IMF screws with surgical guide PROCEDURE

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

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, 41522, Egypt

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Mandibular Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Wounds and Injuries

Study Officials

• Mohamed A Elsholkamy, Professor

  Suez Canal University

  STUDY DIRECTOR

• Yasser N Helmy, Prof

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

  STUDY DIRECTOR

• mohamed H Elsherbiny, Dr

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 19, 2025
• Study Start: April 27, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 19, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)