Development and clinical efficacy evaluation of a personalized AMSDO device for cleft palate secondary maxillary hypoplasia

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000037165

Enrollment

Unknown

Registered

2020-08-27

Start date

2021-03-01

Completion date

Unknown

Last updated

2020-10-05

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

Conditions

Cleft lip and palate

Interventions

Anterior distraction osteogenesis group:Built-in maxillary sagittal distraction device

Orthognathic group:Bilateral mandibular ramus split sagittal osteotomy

Eligibility

Sex/Gender

All

Age

18 Years to 28 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-28 years old; (2) Unilateral or bilateral cleft lip and palate; (3) Alveolar process fracture bone graft has been completed and the recovery is good; (4) Skeletal Class III malocclusion, underdevelopment of the maxillary bone, cannot be improved by orthodontic treatment alone after combined orthognathic consultation; (5) The maxillary first molars and first and second premolars exist, and there is no tooth defect

Exclusion criteria

Exclusion criteria: (1) Have a history of orthognathic surgery or orthodontic treatment; (2) Severe periodontal disease; (3) Other maxillofacial syndromes, etc.; (4) Unable to cooperate with treatment.

Design outcomes

Primary

Measure	Time frame
Need ratio;	—

Secondary

Measure	Time frame
rate of velopharyngeal incompetence;	—

Countries

China

Contacts

Public ContactMin Zhu

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

zminnie@126.com+86 18916093273

Outcome results

None listed

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