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Clinical study on segmental osteotomy guides

Clinical study on inter-dental osteotomy guides for Le Fort I segmental osteotomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106394
Enrollment
Unknown
Registered
2025-07-23
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Maxillary prognathism

Interventions

Experimental group:The position and direction of the osteotomy line were digitally designed for the patients who underwent maxillary Le Fort type I block osteotomy in the experimental group, and the i
Control group:The control group used digital design to plan the position and direction of the osteotomy line before surgery, but used free hands to complete the osteotomy operation during the operatio

Sponsors

Peking University Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1.Individuals diagnosed with maxillary protrusion; 2.Requires maxillary Le Fort I osteotomy with interdental segmentation (premolar region inter-dental osteotomy); 3. Age 18-35 years.

Exclusion criteria

Exclusion criteria: 1.Patients who declined inter-dental osteotomy guide plate surgery; 2.Missing, carious, or previously treated teeth (including restorative, endodontic, or prosthetic treatments) adjacent to the osteotomy line; 3.Patients with moderate to severe periodontitis; 4.Patients lost to scheduled follow-up; 5.Patients with cleft lip/palate, congenital craniofacial deformities, or post-traumatic orthognathic surgery.

Design outcomes

Primary

MeasureTime frame
Severity of periodontal injury;Root Injury Rate;Pulp degeneration rate;Osteotomy Accuracy;

Secondary

MeasureTime frame
Operative time and intra-operative blood loss;Accuracy of Surgical Outcomes;Incidence of other complications;

Countries

China

Contacts

Public ContactQiu Tiancheng

Peking University Hospital of Stomatology

18612882973@163.com+86 18515186496

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026