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NCT Number: NCT07418684

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

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.

Recruiting

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Key information

Conditions

Orthognathic Surgery

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University, Cairo, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

two customized titanium plates

Procedure

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

Other names: two titanium miniplates

four customized titanium plates

Procedure

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

Other names: four titanium miniplates

Primary outcomes

  1. assessment of the accuracy of plan transfer

    Time frame: within one week

    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.

Secondary outcomes

  1. patient satisfaction

    Time frame: 6 months

    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.

Other outcomes

  1. Bite force

    Time frame: 6 months

    Bite force measurement device by newton

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Gamal Hammad, master degree

CONTACT

[email protected]

01000687772 ext. 01000687772

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Accuracy of Maxillary Two Customized 3D Titanium Miniplates Versus Four Customized 3D Miniplates for Virtual Plan Transfer in Orthognathic Surgery. Randomized Clinical Trial.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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