Assessment of 3D-printed patient specific scaffolds for nasoalveolar augmentation in patients with cleft lip-related paranasal maxillary deformities.

Osteopore Limited0 个研究点目标入组 5 人开始时间: 2023年9月13日最近更新: 2023年9月18日

试验速览

暂无简介。

•Patients must fulfil all the following criteria to be eligible for the trial:
•Patients being treated at the Queensland Children’s Hospital scheduled to undergo a secondary alveolar bone graft or rhinoplasty.
•Sagittal bony projection discrepancy of the piriform region of the maxilla on the cleft side greater than 2mm compared to the non-cleft side following palatal expansion and dental arch alignment.
•Adequate nasal closure for the scaffold when placed along and potentially overlapping the piriform margin.
•Patients aged between 4 and 18 years of age.
•Patient, and their parent/guardian if applicable, willing and able to comply with the study requirements.
•Guardian (or patient if Gillick competent) capable of providing valid informed consent

•Patients meeting any of the following criteria will be excluded from the trial:
•Current smokers.
•Syndromes associated with poor wound healing.
•Patient or guardian unwilling or unable to provide fully informed consent.
•Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy, or other cause for secondary/primary immunodeficiency.
•Known severe concurrent or inter-current illness including but not limited to cardiovascular, respiratory, or immunological illness, psychiatric disorders, or possible allergies (including allergy to PCL) that, at the discretion of the clinical lead Dr Yun Phua, would compromise the participant safety or compliance, or interfere with interpretation of study results.
•Unable or unwilling to comply with the study requirements.
•Unreliable follow up record (i.e. multiple failed attendances for their regular follow-up appointments).

发起方

Osteopore Limited