Two versus four custom 3D titanium plates for upper jaw repositioning
Official title: Accuracy of Maxillary Two Customized 3D Titanium Miniplates Versus Four Customized 3D Miniplates for Virtual Plan Transfer in Orthognathic Surgery. Randomized Clinical Trial.
Run by Cairo University · NCT07418684 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 2 sites (Cairo and 1 other locations) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | March 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07418684 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Hemodynamic Changes and Trigeminocardiac Reflex During Bimaxillary Orthognathic Surgery
This study tests how blood pressure, heart rate, and oxygen levels change during bimaxillary orthognathic surgery and whether the trigeminocardiac reflex occurs.
-
Changes in Depression and How Patients Perceive Their Appearance After Double-Jaw Orthognathic Surgery
This study tests whether undergoing bimaxillary orthognathic surgery changes depressive symptoms and self-perceived facial appearance in adults with dentofacial deformities.
-
Tooth-and-bone–guided, patient-specific implant for surgery-first jaw realignment
This study tests a tooth-and-bone supported surgical guide with custom patient-specific implants to help perform bimaxillary jaw surgery for dentofacial deformities using a surgery-first approach.
-
Preemptive pain relief for jaw surgery
This study tests whether giving pain medicine before surgery reduces early postoperative pain for adults having orthognathic (jaw) surgery.
-
How jaw surgery changes posture and foot pressure
This study will test whether orthognathic (jaw) surgery changes head and body posture and how weight is distributed on the feet in adults having corrective jaw surgery compared with similar non‑surgical individuals.
-
Hilotherapy versus Kinesio taping for recovery after bimaxillary jaw surgery
This study will test whether kinesio taping or hilotherapy reduces swelling, pain, and limited mouth opening in adults after bimaxillary orthognathic (jaw) surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.