Accuracy of Patient Specific 3D Printed Titanium Plates Versus Milled Titanium Plates in Genioplasty Orthognathic Surgeries.

January 8, 2026 updated by: Mina ElHadidi Sobhi Ramzi Michael, Cairo University

Accuracy of Patient Specific 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgeries. A Randomized Controlled Clinical Trial

To assess accuracy of patient specific 3D printed titanium plates versus 3D milled titanium plates in genioplasty orthognathic surgery

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

the first treatment include treating patients with 3D printed titanium plates while the second treatment include treating patients with 3D milled titanium plates in genioplasty orthognathic surgery and assess the accuracy between the two treatments

Study Type

Interventional

Enrollment (Estimated)

26

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

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:

  1. Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
  2. Patients with no signs or symptoms of active TMDs.
  3. Highly motivated patients.

Exclusion Criteria:

  1. Patients who refused to be included in the research.
  2. Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
  3. Patients with intra-bony lesions or infections that may retard the osteotomy healing.
  4. Patients with systemic condition contraindicating with the surgical procedure as uncontrolled diabetes

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Experimental : genioplasty using 3D printed patient specific titanium plates (study group) The first treatment plan includes fixing the chin with 3D printed patient specific titanium plates in genioplasty orthognathic surgery
Procedure: genioplasty using 3D printed patient specific titanium plates (study group)
genioplasty using 3D printed patient specific titanium plates (study group) the treatment plan includes fixing the chin with 3D printed patient specific titanium plates in genioplasty orthognathic surgery
Experimental: control Group
Experimental : genioplasty using 3D milled patient specific titanium plates (study group) The second treatment plan includes fixing the chin with 3D milled patient specific titanium plates in genioplasty orthognathic surgery
Procedure: genioplasty using 3D milled patient specific titanium plates (control group)
genioplasty using 3D milled patient specific titanium plates (control group) The treatment plan includes fixing the chin with 3D milled patient specific titanium plates in genioplasty orthognathic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty
Time Frame: immediately postoperative

Accuracy of manufacturing of the patient specific customized 3D printed titanium plates in the study group versus milled titanium plates in the control group in genioplasty measure 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 measurement tool is CBCT scans superimposition in mm
immediately postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stability of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty
Time Frame: 6 months postoperative

stability of manufacturing of the patient specific customized 3D printed titanium plates in the study group versus milled titanium plates in the control group in genioplasty 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 6 months post-operative CBCT scans.

the measurement tool is CBCT scans superimposition in mm
6 months postoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue dehiscence
Time Frame: 2 months postoperatively
measurement of the amount of dehiscence and exposure of the plate and bone vertically and horizontally by periodontal probe the measurement tool is periodontal probe
2 months postoperatively
Patient satisfaction
Time Frame: at the recruitment visit and 6 months postoperative

by Condition specific questionnaire asking the patient with score for satisfaction of the result and to assess the quality of life 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.

the measument tool is questionaire chart
at the recruitment visit and 6 months postoperative

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Chair: Mohamed Mounir Shaker, Cairo University
  • Study Director: Rofaida Atef Abaas, Cairo University
  • Study Director: Mohamed Ali Zain El Abdeen Abd El Wahab, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

November 1, 2026

Primary Completion (Estimated)

May 10, 2027

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

December 26, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • patient specific genioplasty

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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