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Trial registered on ANZCTR


Registration number
ACTRN12622001002774
Ethics application status
Approved
Date submitted
18/06/2022
Date registered
15/07/2022
Date last updated
15/07/2022
Date data sharing statement initially provided
15/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of 3D-printed patient specific scaffolds for vertical mandibular bone regeneration following ablative and reconstructive surgery
Scientific title
Assessment of 3D-printed patient specific scaffolds for vertical mandibular bone regeneration following ablative and reconstructive surgery
Secondary ID [1] 307345 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vertical height discrepancy between neomandible and native mandible 326689 0
Condition category
Condition code
Cancer 323930 323930 0 0
Head and neck
Injuries and Accidents 323932 323932 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is an open label, single-arm feasibility trial study of dental implants to be run at Metro North Health through the Oral and Maxillofacial Surgery unit at the Royal Brisbane and Women’s Hospital (RBWH), with collaboration from the supporting department Herston Biofabrication Institute. The mPCL-TCP scaffold implants and are manufactured by Osteopore (Singapore). Osteopore has implants made from the same material listed on the ARTG (eg ARTG ID 334287).

Use of participant specific medical grade polycaprolactone and tricalcium phosphate (mPCL-TCP) scaffolds in conjunction with autologous bone chips, injectable platelet rich fibrin (i-PRF) and cancellous bone aspirate (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. Participants will be recruited from patients already treated by the Oral and Maxillofacial Surgery Unit who are being reviewed regularly for surveillance of their pathology. Pre-implantation of the scaffold, all participants will undergo a fine slice of CT facial bones, that is anticipated to take around 15-20 minutes, for scaffold design. Participant specific mPCL-TCP scaffold outlines will be designed from participant CT data by biomedical engineers at the Herston Biofabrication Institute with iterative input from the treating clinicians from the RBWH Oral and Maxillofacial Surgery unit. The scaffold will then be manufactured by Osteopore (Singapore).

Surgical placement of the scaffold will be performed under a general anaesthetic at the RBWH by Oral and Maxillofacial consultants at the same time as removal of the reconstruction plate.

Surgery typically takes around 3-4 hours and involves making a neck incision through the previous scar, removing the reconstruction plate, preparing the site for scaffold implantation and implanting the mPCL-TCP scaffold. Thereafter, autologous bone graft particles collected during the scaffold placement preparation and i-PRF and cancellous bone aspirate will be injected in the scaffold. Autologous bone graft will be collected from the iliac crest. The quantity depends on the size of the scaffold, but is estimated to be 2-3mls of compressed bone. Nine months after scaffold placement, a repeat CT will be performed to evaluate the amount of bone formed within the scaffold. A subsequent procedure involving placement of standard Neoss dental implants (as is standard of care for patients who have undergone ablative surgery and reconstruction to the mandible with either a fibula free flap reconstruction, or a marginal mandibulectomy) will be performed to facilitate complete dental rehabilitation. At the time of preparation of the dental implant osteotomy, a core of bone will be taken for histopathologic analysis for the study.
Intervention code [1] 323808 0
Treatment: Surgery
Intervention code [2] 323809 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331742 0
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.
Timepoint [1] 331742 0
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.
Secondary outcome [1] 410969 0
To assess histologically the quality of bone regenerated using participant-specific mPCL-TCP scaffolds with i-PRF, autologous bone chips CBA. This will be performed on the bone cores taken during placement of dental implants, which will be analysed using MicroCT and histological analysis. Bone cores will be processed and analysed for bone quality and architecture as well as vascularity
Timepoint [1] 410969 0
Placement of dental scaffold, 9 months after scaffold implantation
Secondary outcome [2] 410970 0
To assess the degree of dental implant osseointegration into the vertically regenerated bone radiographically and clinically. A CT will be performed 3 months after placement of dental implants to allow sufficient time of osseointegration. This will allow for analysis of the osseointegration of the implants as well as further analysis of the vertical bone growth into the scaffold. Implant stability quotient (ISQ) will be measured during the second stage procedure to clinically assess the level of osseointegration.
Timepoint [2] 410970 0
The CT and ISQ will be performed 3 months after placement of dental implants to allow sufficient time of osseointegration.
Secondary outcome [3] 410971 0
To subjectively assess the functional outcome of this new technique through qualitative participant questionnaires. Participant QoL will be evaluated by the standardized and validated questionnaires – OHIP-14 will be provided to evaluate qualitatively the impact of the procedures on the participant’s daily life.
Timepoint [3] 410971 0
Quality of Life (QoL) will be given at enrolment, review after scaffold implantation, review on outpatient follow up (9 month), review after dental implant placement (12 month), and review after final dental rehabilitation (24 month).
Secondary outcome [4] 411770 0
Participant satisfaction will be evaluated using a questionnaire with a 10cm visual analogue scale (VAS) to subjectively assess the participants perception of the facial appearance after surgery, whether there was pain of dysfunction from the vertical augmentation, the overall satisfaction with the treatment outcomes, and whether the participant would recommend the treatment to other patients
Timepoint [4] 411770 0
Patient satisfaction surveys will be given at enrolment, review after scaffold implantation, review on outpatient follow up (9 month), review after dental implant placement (12 month), and review after final dental rehabilitation (24 month).

Eligibility
Key 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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/07/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22583 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 37837 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 311634 0
Government body
Name [1] 311634 0
Metro North Health Collaborative Research Grant
Country [1] 311634 0
Australia
Primary sponsor type
Government body
Name
Metro North Health
Address
Level 14, Block 7, RBWH, Butterfield Street, Herston, QLD, 4029
Country
Australia
Secondary sponsor category [1] 313313 0
None
Name [1] 313313 0
Address [1] 313313 0
Country [1] 313313 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311091 0
The Royal Brisbane and Women’s Hospital Human Research Ethics Committee (HREC) (EC00172)
Ethics committee address [1] 311091 0
Ethics committee country [1] 311091 0
Australia
Date submitted for ethics approval [1] 311091 0
04/03/2022
Approval date [1] 311091 0
07/03/2022
Ethics approval number [1] 311091 0
HREC/2021/QRBW/81371

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119910 0
Dr Omar Breik
Address 119910 0
Maxillo Facial Outpatient Clinic, Level 8, Ned Hanlon Building, RBWH, Herston, QLD, 4029
Country 119910 0
Australia
Phone 119910 0
+61 07 36463156
Fax 119910 0
Email 119910 0
omar.breik@health.qld.gov.au
Contact person for public queries
Name 119911 0
Omar Breik
Address 119911 0
Maxillo Facial Outpatient Clinic, Level 8, Ned Hanlon Building, RBWH, Herston, QLD, 4029
Country 119911 0
Australia
Phone 119911 0
+61 07 3497 3588
Fax 119911 0
Email 119911 0
omar.breik@health.qld.gov.au
Contact person for scientific queries
Name 119912 0
Omar Breik
Address 119912 0
Maxillo Facial Outpatient Clinic, Level 8, Ned Hanlon Building, RBWH, Herston, QLD, 4029
Country 119912 0
Australia
Phone 119912 0
+61 07 3497 3588
Fax 119912 0
Email 119912 0
omar.breik@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.