Menu
Recruiting NCT07418684

Accuracy of Maxillary Two Customized 3D Titanium Miniplates Versus Four Customized 3D Miniplates

No phase Interventional Orthognathic Surgery

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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗