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Nasolabial soft tissue changes after Conventional Le Fort I osteotomy versus Subspinal Le Fort I osteotomy: A prospective clinical trial

Nasolabial soft tissue changes after Conventional Le Fort I osteotomy versus Subspinal Le Fort I osteotomy: A prospective clinical trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20260701012
Enrollment
26
Registered
2026-07-01
Start date
2026-06-08
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

The study focuses on non-growing patients presenting with dentofacial deformities who require corrective orthognathic surgery, particularly a Le Fort I osteotomy with maxillary advancement and/or impaction. This condition category encompasses severe bite issues such as Class II and Class III malocclusions, facial asymmetry, and midface hypoplasia Orthognathic Surgery , Le Fort I osteotomy, Dentofacial Deformities , Soft tissue changes

Interventions

Conventional Le Fort I osteotomy (CLFIO) is performed by one surgeon in the Oral and Maxillofacial Surgery (OMFS) Department, Faculty of Dentistry, Chulalongkorn University. The maxilla is approached
Treatment,Treatment
Conventional Le Fort I osteotomy (CLFIO),Subspinal Le Fort I Osteotomy (SLFIO)

Sponsors

The Royal College of Dental Surgeons of Thailand
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with ASA physical status class I or II 2. Patients with dentofacial deformities requiring orthognathic surgery treatment with Le Fort I osteotomy with maxillary advancement and/or impaction (without segmentation) and non-growing patients 3. Patients with no previous trauma at oral and maxillofacial region

Exclusion criteria

Exclusion criteria: 1. Patients with craniofacial syndrome such as cleft lip and palate 2. Patients with history of midfacial surgery such as rhinoplasty 3. Patients with history of any aesthetic procedure affecting nasolabial region 4. Patients with previous pathology in maxilla or mandible 5. Patients with previous orthognathic surgery

Design outcomes

Primary

MeasureTime frame
Interalar Width at 3-4 weeks before surgery and 6 months after surgery The measurement is taken from static 3D facial scanner,Alar base width at 3-4 weeks before surgery and 6 months after surgery The measurement is taken from static 3D facial scanner ,Nasolabial angle at 3-4 weeks before surgery and 6 months after surgery The measurement is taken from static 3D facial scanner,Upper lip length at 3-4 weeks before surgery and 6 months after surgery The measurement is taken from static 3D facial scanner

Secondary

MeasureTime frame
Maxilla movement at 3-4 weeks before surgery and 6 months after surgery The measurement is taken from Cone-Beam Computed Tomography (CBCT) datasets analyzed in Dolphin Imaging software

Countries

Thailand

Contacts

Public ContactChatchaya Petchphayaprai

Faculty of Dentistry, Chulalongkorn University

junechatchaya@gmail.com0824584415

Outcome results

None listed

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