Assessment of 3D-printed patient specific scaffolds for vertical mandibular bone regeneration following ablative and reconstructive surgery

Not Applicable

• Conditions: Vertical height discrepancy between neomandible and native mandible; Cancer - Head and neck; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12622001002774
• Lead Sponsor: Metro North Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-15
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

•Patients under surveillance after head and neck ablation and reconstruction – within 6-
24 months post-surgery
•Patients interested in oral/dental rehabilitation
•Significant vertical bony height discrepancy (Minimum of 6mm height discrepancy
between native mandible and level of resected/neomandible)
•Not previously irradiated
•Adequate soft tissue to cover scaffold
•Women of reproductive age who are currently on one of the following methods of contraception:
-Barrier method of contraception: condoms (male or female) with or without
spermicidal agent, diaphragm, or cervical cap with spermicide
-Intrauterine device
-Hormone-based contraceptive
•Participant willing and able to comply with the study requirements
•Participant or guardian capable of providing valid informed consent

Exclusion Criteria

•Irradiated patients
•Current smokers
•Poorly controlled diabetics (HbA1c of >7%)
•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: cardiovascular, respiratory, or immunological illness, psychiatric disorders, or alcohol or chemical dependence, or possible allergies (including allergy to PCL) that, at the discretion of the clinical leads Dr Omar Breik and A/Prof Martin Batstone, would compromise the participant safety or compliance or interfere with interpretation of study results.
•Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the reconstruction surgery.
•Women of childbearing potential without an appropriate contraceptive method.
•Life expectancy less than 24 months.
•Unable or unwilling to comply with the study requirements.
•Patients unlikely to proceed to dental rehabilitation (These are usually patient who are not interested in undergoing multiple procedures for rehabilitation, patients who have multiple failed appointments, poor oral hygiene, or advanced dental disease affecting their remaining teeth such as periodontitis or dental caries.)
•Unreliable follow up record (Multiple failed attendances for their regular follow up appointments)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary composite outcome point of the study is to assess the feasibility and efficacy of using participant specific mPCL-TCP scaffolds in conjunction with autologous bone chips, i-PRF and CBA for vertical augmentation of the neo-mandible for participants who have undergone ablative surgery and reconstruction to the mandible with either a fibula free flap reconstruction, or a marginal mandibulectomy. This will be assessed by determining the level of bone formation (measured in bone volume) in the scaffold. This will be measured in bone volume from the CT scan, and from histopathological analysis of cores taken at the time of dental implant placement.[This will be assessed in 2 stages: the first stage a CT scan will be performed 9 months after placement of the mPCL-TCP scaffold. In the second stage a CT scan will be performed 3 months after the placement of dental implants.<br><br>]