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Evaluating the Clinical Efficacy of Digital-Assisted Maxillary Le Fort I Combinedwith Anterior Segmental Osteotomy and Distraction Osteogenesis for the Treatment of Maxillofacial Deformities Secondary to Cleft Lip and Palate repair

Evaluating the Clinical Efficacy of Digital-Assisted Maxillary Le Fort ICombined with AnteriorSegmentalOsteotomyDistractionandOsteogenesis for the Treatment of Maxillofacial Deformities Secondary toCleft Lip and Palate repair

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121135
Enrollment
Unknown
Registered
2026-03-26
Start date
2026-03-26
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Maxillary Hypoplasia Secondary to Cleft Lip and Palate repair

Interventions

Observation group: Combined traction group:None
Control group: Orthognathic surgery group:None

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with secondary skeletal Class III malocclusion following cleft lip and palate repair. 2. Study group: patients undergoing single-jaw surgery (maxillary distraction osteogenesis); Control group: patients undergoing bimaxillary orthognathic surgery. 3. Aged =10 years, in the late or post-pubertal growth phase. 4. Good compliance and good oral hygiene, able to cooperate with treatment, postoperative oral care, and follow-up. 5. Understood and agreed to participate in this study, and voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Syndromic diseases associated with cleft lip and palate. 2. History of maxillofacial trauma and fracture, or history of tumors. 3. Previous history of orthognathic surgery or distraction osteogenesis. 4. Uncontrolled severe periodontal disease or temporomandibular disorders (TMD). 5. Uncontrolled severe systemic diseases such as diabetes mellitus. 6. Severe long-term smoking or alcohol abuse that may impair bone healing. 7. Intolerance to treatment, poor compliance, or inability to attend regular follow-up.

Design outcomes

Primary

MeasureTime frame
The distance of the anterior movement of the subspinale(A) along the sagittal axis;

Secondary

MeasureTime frame
The positional changes of the maxilla and mandible and the three-dimensional movement distances of the teeth based on three-dimensional measurement;The average forward displacement of the left upper lip, right upper lip, the area above the left corner of the mouth, the area above the right corner of the mouth, the left parasal area, and the right parasal area before and after treatment;Osteogenic volume and osteogenic density;Changes of axillary crowding degree before and after treatment;Changes in velopharyngeal anatomy and upper airway volume before and after treatment;Changes of the speech clear degree before and after treatment;Duration of the operation;Intraoperative blood loss;Incidence of postoperative complications;Relapse rate;The satisfaction of patients;

Countries

China

Contacts

Public ContactCai Ming

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

zidanecm500@126.com+86 139 1849 0900

Outcome results

None listed

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