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Clinical trials of 3D printing in fabrication of prosthesis for regeneration of cleft palate disorders or orbital fracture

Fabrication and Clinical trial of biodegradable composite meshes manufactured through additive manufacturing for application in orbital fracture and cleft palate

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220807055633N2
Enrollment
7
Registered
2023-02-25
Start date
2023-03-11
Completion date
Unknown
Last updated
2023-03-13

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

Conditions

Condition 1: Flexible surgical mesh for cleft palate repair. Condition 2: Flexible surgical mesh for orbital fracture repair. Cleft palate, unspecified Fracture of orbital floor

Interventions

Intervention group: The diagnostics for this intervention include patients who suffer from cleft palate congenital disorders or patients who have suffered from a traumatic accident and are diagnosed w

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: People who have skull and face defects and the use of plates in surgery cannot correct the shape of the bone.

Exclusion criteria

Exclusion criteria: Having an underlying disease, including allergies

Design outcomes

Primary

MeasureTime frame
Close the gap in the roof of the mouth and rearrangement of the muscles and the lining of the palate. Timepoint: 2 weeks and 4 months after the surgery. Method of measurement: in person patient examination.;Orbital floor fracture repair. Timepoint: 3 and 6 months after the surgery. Method of measurement: in person patient examination and CT-scan imaging.

Secondary

MeasureTime frame
Natural patient ingrowth within the implants structure. Timepoint: 6 months after the surgery. Method of measurement: CT scan imaging and in person patient examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Ali Poursamar

Esfahan University of Medical Sciences

ali.poursamar@amt.mui.ac.ir+98 31 3792 3865

Outcome results

None listed

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