Healing Mechanisms of Bone and Soft Tissue Defects in the LeFort I Osteotomy Site

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600123107

Enrollment

Unknown

Registered

2026-04-21

Start date

2025-11-17

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Dentofacial deformity

Interventions

Observation group:None

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Part I: Protocol for Retrospective Cohort Study Inclusion Criteria: 1. Aged 18 years or older and 65 years or younger, regardless of gender. 2. Clinically diagnosed with skeletal malocclusion accompanied by maxillary hypoplasia, having undergone maxillary LeFort I osteotomy with a maxillary movement distance > 3 mm. 3. Complete availability of surgical design plans, imaging data, and operative records. Part II: Protocol for Prospective Observational Study and Basic Mechanism Study Inclusion Criteria: 1. Meeting the inclusion criteria of Part I (i.e., aged 18–65 years, having undergone maxillary LeFort I osteotomy with a maxillary movement distance > 3 mm). 2. Diagnosed with postoperative chronic maxillary sinusitis during secondary titanium plate removal surgery based on clinical manifestations and CT findings (e.g., increased sinus density, air-fluid levels, etc.), and clinically determined to require sinus irrigation. 3. Willing to participate in the study and having provided written informed consent.

Exclusion criteria

Exclusion criteria: Part I: Protocol for Retrospective Cohort Study Exclusion Criteria: 1. Patients with severe skeletal deformities or bone defects caused by trauma, cleft lip and palate, tumors, etc. 2. Patients diagnosed with chronic maxillary sinusitis prior to orthognathic surgery. 3. Patients with systemic diseases (e.g., diabetes mellitus, autoimmune deficiency syndrome). 4. Patients with contraindications to orthognathic surgery. Part II: Protocol for Prospective Observational Study and Basic Mechanism Study Exclusion Criteria: Patients who refuse to sign the informed consent form.

Design outcomes

Primary

Measure	Time frame
Single-cell sequencing and analysis results ;	—

Secondary

Measure	Time frame
Three-dimensional displacement of maxillary and mandibular landmarks.;	—

Countries

China

Contacts

Public ContactXie Zhijian

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

xzj66@zju.edu.cn+86 139 5817 9558

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026