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Comparison of the accuracy of maxillary reposition with customized fixation miniplates and CAD/CAM splints in two-jaw orthognathic surgery

Comparison of the accuracy of maxillary reposition with customized fixation miniplates and CAD/CAM splints in two-jaw orthognathic surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251029001
Enrollment
28
Registered
2025-10-29
Start date
2025-10-13
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skeletal dentofacial deformity Orthognathic Surgery Orthognathic Surgical Procedures Computer-Aided Design Occlusal Splints Maxillary Osteotomy 3D printing

Interventions

CAD/CAM-designed occlusal splints fabricated using 3D printing based on virtual surgical planning (VSP). These splints are used intraoperatively to guide maxillary repositioning during orthognathic su
Active Comparator Device,Experimental Device
CAD/CAM Splints,Customized Fixation Miniplates

Sponsors

Faculty of Dentistry, Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Patients aged over 18 years 2) Patients diagnosed with skeletal dentofacial deformity who require bimaxillary orthognathic surgery

Exclusion criteria

Exclusion criteria: 1) Patients with craniofacial syndromes 2) Patients with a history of prior jaw surgery 3) Patients who have experienced trauma to the maxilla or mandible 4) Patients requiring maxillary segmental osteotomy 5) Patients with unilateral or bilateral cleft lip and palate 6) Patients with craniofacial abnormalities resulting from tumors, trauma, or iatrogenic factors

Design outcomes

Primary

MeasureTime frame
Accuracy of maxillary repositioning 14 days after surgery Mean linear deviation (mm) between planned and actual postoperative positions

Secondary

MeasureTime frame
Operative time During surgery Total surgical duration (minutes),Postoperative complications Within 14 days after surgery Number and type of adverse events

Countries

Thailand

Contacts

Public ContactThanapon Jiamwisitkul

Faculty of dentistry, Chulalongkorn University

thanapon.jiamwisitkul@gmail.com022188581

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026