Scaffold for Nasoalveolar Augmentatio

Not Applicable

Not yet recruiting

• Conditions: asoalveolar Augmentation; Nasoalveolar Augmentation; Surgery - Surgical techniques

• Registration Number: ACTRN12623001002673
• Lead Sponsor: Osteopore Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-13
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

Exclusion Criteria

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified