Two versus four custom 3D titanium plates for upper jaw repositioning
Accuracy of Maxillary Two Customized 3D Titanium Miniplates Versus Four Customized 3D Miniplates for Virtual Plan Transfer in Orthognathic Surgery. Randomized Clinical Trial.
This test sees if using two custom 3D titanium plates instead of four gives equally accurate virtual-plan transfer for people having orthognathic (jaw) surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT07418684 on ClinicalTrials.gov |
What this trial studies
Patients will undergo virtual surgical planning and receive patient-specific 3D titanium miniplates designed to match the planned maxillary repositioning. Participants will be fixed with either two or four customized plates in place of traditional wafers, and surgeons will perform the planned osteotomies and repositioning. Postoperative imaging will be used to quantify how closely the actual bone positions match the virtual plan and to compare accuracy between the two groups. The protocol excludes patients with systemic diseases that impair healing, active temporomandibular disorders, intra-bony lesions or infections, or those unfit for general anesthesia.
Who should consider this trial
Good fit: Adults with dentofacial disharmony who need orthognathic surgery, are medically fit for general anesthesia, have no active TMD, and can attend follow-up visits.
Not a fit: Patients with systemic conditions that impair bone healing, active infections or intra-bony lesions, active TMD, or those unwilling/unable to follow up may not benefit or be eligible.
Why it matters
Potential benefit: If successful, this could allow use of fewer plates while maintaining surgical accuracy, reducing hardware, operating time, and potentially cost.
How similar studies have performed: Previous reports indicate custom 3D plates can improve virtual-plan transfer compared with traditional wafers, but direct comparisons of two versus four maxillary plates are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cairo and 1 other locations
- Cairo University — Cairo, Egypt (Recruiting)
- faculty of dentistry Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Gamal Hammad, master degree
- Email: mohamed.hammad@dentistry.cu.edu.eg
- Phone: 01000687772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.