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A random controlled trial of BMP-2 loaded with ß-TCP to repair the alveolar cleft bone defects

A random controlled trial of BMP-2 loaded with ß-TCP to repair the alveolar cleft bone defects

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112717
Enrollment
Unknown
Registered
2025-11-18
Start date
2023-07-10
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Nonsyndromic unilateral alveolar clefts

Interventions

Control Group:removal of bone from ilium
Experimental Group:Artificial material implantation

Sponsors

Beijing Stomatological Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: a.Nonsyndromic unilateral alveolar clefts; b.The test results of CBCT show :(1)the length of canine root has been developed into 1/2 to 2/3.(2)the cleft is located between the lateral incisor and the canine.If the lateral incisor is congenital absence ,then the cleft is located between the incisor and the canine. Or the children from 9 to 12 years old,without limitation of gender.

Exclusion criteria

Exclusion criteria: a.The breadth of alveolar cleft is wider than 1.5cm. b.The proximal and distal interrupted ends of alveolar cleft is obviously labio-palatine dislocation. c.The space of alveolar cleft is occupied by dental crowns. d.Patients with mental or intellectual disabilities.

Design outcomes

Primary

MeasureTime frame
bone filling in clefts 1 year after operation ;bone filling in clefts 6 months after operation ;

Countries

China

Contacts

Public ContactRenji Chen

Beijing Stomatological Hospital Capital Medical University

chenrenji@126.com+86 135 0121 6911

Outcome results

None listed

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