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

NCT07418684 | Recruiting DMC

• 1 other identifier: 3-3-10
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Orthognathic Surgery

Keywords

virtual surgical planning; Le fort 1; PSSO

Outcome Measures

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.

  within one week

Secondary Outcomes (1)

• patient satisfaction

  6 months

Other Outcomes (1)

• Bite force

  6 months

Study Arms (2)

two customized titanium plates for virtual plan transfer in orthognathic surgery

EXPERIMENTAL

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

Procedure: two customized titanium plates

four customized titanium plates for virtual plan transfer in orthognathic surgery

ACTIVE COMPARATOR

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

Procedure: four customized titanium plates

Interventions

two customized titanium plates PROCEDURE

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

Also known as: two titanium miniplates

two customized titanium plates for virtual plan transfer in orthognathic surgery

four customized titanium plates PROCEDURE

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

Also known as: four titanium miniplates

four customized titanium plates for virtual plan transfer in orthognathic surgery

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Cairo University

Cairo, 14444, Egypt

RECRUITING

faculty of dentistry Cairo University

Cairo, 14444, Egypt

RECRUITING

Central Study Contacts

Mohamed Gamal Hammad, master degree

CONTACT

01000687772; mohamed.hammad@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: two customized titanium plates for virtual plan transfer in orthognathic surgery

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 18, 2026
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

EG (2)