Clinical trial NCT06883331: Validity of Computed Guided Technology in Proper Placement of Intermaxillary Fixation Screws in Mandibular Fractures
Official title: Validity of Computed Guided Technology in Proper Placement of Intermaxillary Fixation Screws in Mandibular Fractures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mandibular Fractures
Keywords: mandible
fracture
fixation
screws
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: radiographic evaluation
timeFrame: immediately postoperative
Secondary outcomes:
measure: clinical evaluation
timeFrame: intra-operative
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
affiliation: Suez Canal University
name: Mohamed A Elsholkamy, Professor
role: STUDY_DIRECTOR
affiliation: Specialized Dental Hospital Kobry el Kobba Military Complex, Military Medical Academy
name: Yasser N Helmy, Prof
role: STUDY_DIRECTOR
affiliation: Specialized Dental Hospital Kobry el Kobba Military Complex, Military Medical Academy
name: mohamed H Elsherbiny, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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