Accuracy of Patient Specific 3D Printed Titanium Plates Versus Milled Titanium Plates in Genioplasty Orthognathic Surgeries.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: genioplasty using 3D printed patient specific titanium plates (study group), genioplasty using 3D milled patient specific titanium plates (control group).
- Who it may be relevant to
- Registry 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. Basic parameters: 19 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Accuracy of Patient Specific 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgeries. A Randomized Controlled Clinical Trial
Overview
To assess accuracy of patient specific 3D printed titanium plates versus 3D milled titanium plates in genioplasty orthognathic surgery
Detailed description
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
Interventions
- Procedure genioplasty using 3D printed patient specific titanium plates (study group)
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 - Procedure genioplasty using 3D milled patient specific titanium plates (control group)
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
Primary outcome measures
- Accuracy of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty [Time frame: immediately postoperative]
Secondary outcome measures (1)
- stability of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty [Time frame: 6 months postoperative]
Eligibility criteria
Inclusion criteria
- Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
- Patients with no signs or symptoms of active TMDs.
- Highly motivated patients.
Exclusion criteria
- Patients who refused to be included in the research.
- Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
- Patients with intra-bony lesions or infections that may retard the osteotomy healing.
- Patients with systemic condition contraindicating with the surgical procedure as uncontrolled diabetes
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Hanafy M, Akoush Y, Abou-ElFetouh A, Mounir RM. Precision of orthognathic digital plan transfer using patient-specific cutting guides and osteosynthesis versus mixed analogue-digitally planned surgery: a randomized controlled clinical trial. Int J Oral Maxillofac Surg. 2020 Jan;49(1):62-68. doi: 10.1016/j.ijom.2019.06.023. Epub 2019 Jun 29. PMID 31262680
- Levine JP, Patel A, Saadeh PB, Hirsch DL. Computer-aided design and manufacturing in craniomaxillofacial surgery: the new state of the art. J Craniofac Surg. 2012 Jan;23(1):288-93. doi: 10.1097/SCS.0b013e318241ba92. PMID 22337427
- Kusnoto B. Two-dimensional cephalometry and computerized orthognathic surgical treatment planning. Clin Plast Surg. 2007 Jul;34(3):417-26. doi: 10.1016/j.cps.2007.04.005. PMID 17692701
Identifiers
NCT: NCT07344441 · patient specific genioplasty