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

February 14, 2026 updated by: mohamed gamal hammad, Cairo University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: two customized titanium plates for virtual plan transfer in orthognathic surgery
two customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field
Procedure: two customized titanium plates
two customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field
Other Names:
  • two titanium miniplates
Active Comparator: four customized titanium plates for virtual plan transfer in orthognathic surgery
four 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
Other Names:
  • four titanium miniplates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bite force
Time Frame: 6 months
Bite force measurement device by newton
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

February 14, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 14, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3-3-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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