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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with no signs or symptoms of active TMDs.

Highly motivated patients.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • two customized titanium plates

    Procedure/Surgery

    two customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field

  • four customized titanium plates

    Procedure/Surgery

    four customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: two customized titanium plates for virtual plan transfer in orthognathic surgeryExperimental treatment 1 intervention
Group B: four customized titanium plates for virtual plan transfer in orthognathic surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

assessment of the accuracy of plan transfer

Specific measurement variable: 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 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.

Time frame
within one week

Secondary outcomes

1

patient satisfaction

A self-administered OQLQ translated into Arabic will be used to assess quality of life at the recruitment visit and six months after the surgery. Questions 1, 7, 10, 11, and 14 will be about facial aesthetics and appearance, questions 2 to 6 will be about oral function, questions 8, 9, 12, and 13 will be about the awareness of the deformity, and questions 15 to 22 will about the social aspect of the deformity. The questionnaire contains 22 questions, and each question has score from 1 to 4, so each patient will have a score from 22 to 88.

Time frame
6 months

Other outcomes

1

Bite force

Bite force measurement device by newton

Time frame
6 months

Sponsors and contacts

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