Accuracy of Maxillary Two Customized 3D Titanium Miniplates Versus Four Customized 3D Miniplates
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: two customized titanium plates, four customized titanium plates.
- Who it may be relevant to
- Registry conditions: Orthognathic Surgery. Basic parameters: 18 years — 40 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
- Egypt
- 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 Maxillary Two Customized 3D Titanium Miniplates Versus Four Customized 3D Miniplates for Virtual Plan Transfer in Orthognathic Surgery. Randomized Clinical Trial.
Overview
In this research the investigators aim to minimize the use of more hardware in the fixation of the orthognathic surgery cases. The objective of this study is to assess the accuracy of the plan transfer with two customized titanium plates versus four customized titanium plates.
Detailed description
In orthognathic surgery cases, maxillary repositioning in three dimensions can be obtained. Recently using the custom-made plates instead of wafer used in classic models can get an accurate plan transfer, however it can get suboptimal accurate repositioning.
The aim of the study is to evaluate the accuracy of two customized titanium plates versus four customized titanium plates in transferring the virtual plan in orthognathic surgeries.
Interventions
- Procedure two customized titanium plates
two customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field - Procedure four customized titanium plates
four customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field
Primary outcome measures
- assessment of the accuracy of plan transfer [Time frame: within one week]
Secondary outcome measures (1)
- patient satisfaction [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
.Patients with dentofacial disharmony and misalignment requiring 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 anesthesia.
- Patients with intra-bony lesions or infections that may retard the osteotomy healing.
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
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 2 centers
- Cairo University — Cairo
- faculty of dentistry Cairo University — Cairo
Identifiers
NCT: NCT07418684 · 3-3-10