A Full Digital VS Conventional Protocol in Management of Zygomatico-Maxillary Complex Fracture

NCT06588075 | Completed

• 1 other identifier: OMFS 3319
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

this study aims To evaluate The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fracture reduction and fixation Using customized Patient-Specific implant and patient-specific predictive holes surgical guide Versus Conventional Technique of reduction and fixation.

Conditions

Zygomatic Fractures

Keywords

Zygomatic fracture; computer guided surgery; patient specific implant; predictive holes surgical guide; Zygomatico-Maxillary complex fracture

Outcome Measures

Primary Outcomes (1)

• Zygomatic reposition

  the accuracy of zygomatic bone reduction and fixation using postoperative CT scan

  immediate postoperative

Secondary Outcomes (3)

• intraoperative time

  during the operation

• paresthesia

  pre operative, immediate postoperative and 6 months post operative

• patient satisfaction

  6 months postoperative

Study Arms (2)

study group

EXPERIMENTAL

all cases that will be allocated in this group will undergo treatment using a full digital protocol depending on planning software and the planning will be carried out into the operating room using 3D printed predictive holes surgical guides to determine accurately the optimum position of customized plates

Procedure: Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow

control group

ACTIVE COMPARATOR

patients in this group will be treated using a conventional protocol of reduction depending on visualization intraoperative and tactile sensation and will be fixed using a stock miniplates and screws.

Procedure: Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol

Interventions

Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow PROCEDURE

All surgeries will be carried out under general anesthesia the fracture lines will be exposed then For the study group: following the exposure of all fracture lines , anatomically seated bone-supported predictive holes surgical guides will be inserted on the bone segments with intimate contact. Each segment hole will be drilled according to the predesigned predictive holes guide. The fractured segments will then be reduced and fixed using titanium miniplates customized for the patient and screws at least two screws for each fracture segment. then closure in layers will be performed using absorbable vicryl for deep layers and intraoral sutures and non-absorbable polyproline for skin closure.

study group

Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol PROCEDURE

For the control group: all cases will be treated under general anesthesia and the fracture lines will be exposed then the conventional protocol of treatment depend mainly on visualization of the fracture line and tactile sensation of the operator intra-operative during reduction procedure and the fixation of fractured segments will be done using titanium miniplates and screws then closure in layers will be performed.

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Zygomatic Fracture Types III, IV, V, VII, and VIII according to Rowe and Killey's classification.
• Age range (18-60 years).
• Patients are willing for the surgical procedure and follow-up, with informed consent

You may not qualify if:

• Zygomatic Fracture Type I, II according to Rowe and Killey's classification.
• Patients with contraindications for general anesthesia.
• Patient on radiotherapy.
• Patients suffer from bone disease.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Zygomatic Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Dina Ayman Fayek, M.Sc

  Assistant lecturer oral and maxillofacial surgery department Future university in Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer in Oral and Maxillofacial department in Future university in Egypt

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 4, 2024
• Primary Completion: June 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

EG (1)