Skip to content

A Small-sample Randomized Controlled Trial on Functional Matrix Release to Reduce Relapse After Mandibular Distraction Osteogenesis in Hemifacial Microsomia

A Small-sample Randomized Controlled Trial on Functional Matrix Release to Reduce Relapse After Mandibular Distraction Osteogenesis in Hemifacial Microsomia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126195
Enrollment
Unknown
Registered
2026-06-04
Start date
2026-06-04
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Hemifacial Microsomia

Interventions

Treatment group:Release of the mandibular ligament
Standard Mandibular Distraction Osteogenesis
Control Group:Standard Mandibular Distraction Osteogenesis

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Pediatric patients aged 6–12 years (inclusive) with hemifacial microsomia; 2.Diagnosed by three-dimensional CT as Pruzansky type II mandible (type IIa: mandibular ramus, condyle, and temporomandibular joint are present but hypoplastic and abnormally shaped; type IIb: mandibular ramus is hypoplastic with significantly abnormal shape and position, being midline or anteriorly positioned, with no articular connection between the mandible and temporal bone); 3.Undergoing first-time mandibular distraction osteogenesis (MDO);

Exclusion criteria

Exclusion criteria: 1.Patients with other concomitant craniofacial deformities; 2.A history of prior maxillofacial surgery; 3.Lack of informed consent from the patient's guardian; 4.Concomitant diseases that contraindicate general anesthesia surgery;

Design outcomes

Primary

MeasureTime frame
Relapse rate at 12 months postoperatively;

Secondary

MeasureTime frame
Facial symmetry;Adverse Events;Complications;Bone structural stability;Laboratory Examinations;Vital Signs;Function and satisfaction;

Countries

China

Contacts

Public ContactXiaojun Chen

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

chenxiaojun1993@sjtu.edu.cn+86 21 2327 1699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026