Accuracy of Patient Specific 3D Printed Titanium Plates Versus Milled Titanium Plates in Genioplasty Orthognathic Surgeries.

N/ANot Yet RecruitingNCT07344441

Cairo University26 enrolled

Overview

To assess accuracy of patient specific 3D printed titanium plates versus 3D milled titanium plates in genioplasty orthognathic surgery

the first treatment include treating patients with 3D printed titanium plates while the second treatment include treating patients with 3D milled titanium plates in genioplasty orthognathic surgery and assess the accuracy between the two treatments

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgery Patient Specific Genioplasty Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty

Interventions

genioplasty using 3D printed patient specific titanium plates (study group)PROCEDURE

genioplasty using 3D printed patient specific titanium plates (study group) the treatment plan includes fixing the chin with 3D printed patient specific titanium plates in genioplasty orthognathic surgery

genioplasty using 3D milled patient specific titanium plates (control group)PROCEDURE

genioplasty using 3D milled patient specific titanium plates (control group) The treatment plan includes fixing the chin with 3D milled patient specific titanium plates in genioplasty orthognathic surgery

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries. 2. Patients with no signs or symptoms of active TMDs. 3. Highly motivated patients. Exclusion Criteria: 1. Patients who refused to be included in the research. 2. Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia. 3. Patients with intra-bony lesions or infections that may retard the osteotomy healing. 4. Patients with systemic condition contraindicating with the surgical procedure as uncontrolled diabetes

Outcomes

Primary Outcomes

Accuracy of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty

Accuracy of manufacturing of the patient specific customized 3D printed titanium plates in the study group versus milled titanium plates in the control group in genioplasty measure The skull base in the virtual surgical plan was superimposed using point-based matching ICP registration using anatomical reference points, followed by manual surface-based registration to surface best fit with the skull base in the actual post-operative CBCT scans. the measurement tool is CBCT scans superimposition in mm

Time frame: immediately postoperative

Secondary Outcomes

stability of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty

stability of manufacturing of the patient specific customized 3D printed titanium plates in the study group versus milled titanium plates in the control group in genioplasty The skull base in the virtual surgical plan was superimposed using point-based matching ICP registration using anatomical reference points, followed by manual surface-based registration to surface best fit with the skull base in the actual 6 months post-operative CBCT scans. the measurement tool is CBCT scans superimposition in mm

Time frame: 6 months postoperative

Central Contacts

Mina ElHadidi Sobhi Ramzi

CONTACT

+201225339712 mina.ramzi@dentistry.cu.edu.eg

Data from ClinicalTrials.gov

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