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Trial registered on ANZCTR


Registration number
ACTRN12622000118707
Ethics application status
Approved
Date submitted
13/11/2021
Date registered
25/01/2022
Date last updated
19/02/2024
Date data sharing statement initially provided
25/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Regenerating human jaw bone using custom 3D printed scaffolds – a preliminary clinical study
Scientific title
Custom 3D printed Polycaprolactone scaffolds in complex alveolar ridge augmentation in partially dentate adults – a preliminary clinical study
Secondary ID [1] 305787 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
alveolar bone deficiency 324295 0
Condition category
Condition code
Oral and Gastrointestinal 321784 321784 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single arm clinical trial assessing the efficacy of a 3D printed custom manufactured medical grade polycaprolactone (PCL) scaffold that is loaded with anorganic bovine bone mineral (ABBM) and particulate autogenous bone (AB) in reconstruction of alveolar ridge defects for the purpose of dental implant rehabilitation. This involves two surgical procedures; the first to reconstruct the alveolar ridge followed by dental implant placement 9 months later and finally prosthetic rehabilitation 3 months after implant placement. This treatment will be provided by a well established research group including clinicians (specialist periodontists) and scientists at a university and specialist private practice. The surgical procedures will be carried out in day surgery under general anaesthesia. The initial procedure will take approximately 2 hours. The following procedure will take 1-2 hours. Both surgical procedures will be followed by post-surgical care at 2 weeks. The prosthetic phase of treatment will carried out by independent restorative clinicians in a private practice setting over typically 3 1 hour appointments. Throughout these clinical procedures the patient is expected to carry out post-surgical home care and then standard oral home care, once restored.
Intervention code [1] 322183 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329548 0
regenerated fraction of the original defect volume
using cone beam CT data and medical engineering software
Timepoint [1] 329548 0
9 months after initial bone augmentation surgery
Secondary outcome [1] 402924 0
absolute volumetric graft change
using cone beam CT data and medical engineering software
Timepoint [1] 402924 0
9 months after initial grafting surgery
Secondary outcome [2] 402925 0
absolute linear graft changes
using cone beam CT data and medical engineering software
Timepoint [2] 402925 0
9 months after initial grafting surgery
Secondary outcome [3] 402926 0
dental implant feasibility
using clinical assessment and digital surgical plans (pre-grafting vs. post-grafting)
Timepoint [3] 402926 0
9 months after initial grafting surgery
Secondary outcome [4] 402927 0
Bone tissue fractions using histological assessment of grafted bone
Timepoint [4] 402927 0
9 months after initial grafting surgery
Secondary outcome [5] 402928 0
Clinical alveolar ridge assessment
Timepoint [5] 402928 0
9 months after initial grafting surgery
Secondary outcome [6] 402929 0
PROMs (grafting) - pain will be measured using 100mm VAS, and an analgesic diary
Timepoint [6] 402929 0
start immediately after grafting surgery and continue daily for 14 days
Secondary outcome [7] 402930 0
PROMs (implant) - pain will be measured using 100mm VAS, and an analgesic diary
Timepoint [7] 402930 0
immediately after dental implant placement and continue daily for 14 days
Secondary outcome [8] 402931 0
Composite parameter - peri-implant mucosa status including marginal bone levels, bleeding on probing, probing depth will measured by intra-oral visual inspection a periodontal probe and an intra-oral radiograph
Timepoint [8] 402931 0
immediately after delivery implant restoration and 12 months after dental implant has been in function.
Secondary outcome [9] 402933 0
Composite parameter - implant restoration status including such as ceramic chipping, screw loosening, screw or abutment fracture will measured by intra-oral visual inspection and an intra-oral radiograph
Timepoint [9] 402933 0
immediately after implant restoration and after 12 months of implant function

Eligibility
Key inclusion criteria
• Individuals were at least 18 years of age, medically healthy or with mild controlled systemic disease, able to undergo oral surgical procedures under local or general anaesthesia (ASA I and II; American Society of Anesthesiologists, Schaumburg, Illinois, USA).
• Adequate plaque control (FM plaque and BOP scores equal to or greater than 25%) at study baseline
• Dental implant replacement of multiple units (2 or more units) in a partially dentate patient
• Alveolar ridge deficiency preventing dental implant placement in a prosthetically driven position with the following characteristics: absence of the buccal wall equal to or greater than 50% of the prospective implant length with or without loss of vertical height (2/4, 3/4 or 4/4 defect) (Terheyden 2010 )
• If bilateral ridge augmentation is required, only one ridge will be randomly selected and used for the purposes of this study.
• Teeth at the surgical site which require removal are extracted a minimum of 12 weeks prior to ridge augmentation
• A minimum zone of 2mm of gingival tissue in buccal aspect of the surgical zone
• Treated and stable periodontal disease as assessed by specialist Periodontists (JA & SI) with stability defined as having a full mouth bleeding score of equal to or greater than 20% and no sites of residual periodontal probing depth equal to or greater than 5mm (Lang & Tonetti 2003).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Pregnancy at the time of recruitment
• Alcoholism or chronic drug abuse
• Patients who smoke more than 10 cigarettes per day
• Medications or pathology which interferes with bone formation
• History of local radiation therapy
• Severe parafunction
• Extensive metallic restorations in region of interest especially post-core restorations
• Presence of dental implant adjacent to region of interest
• Oral mucosal disease such as Lichen Planus

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)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics such as mean (± standard deviation) in addition to median (inter-quartile range) and range (minimum, maximum) as well as absolute and relative frequencies will be provided for baseline and outcome parameters. A paired t-test will be used to compare linear and volumetric changes from CBCT (T0, T1), PROMs reported using VAS and peri-implant parameters (PPD, recession, interproximal bone levels) (T3 & 4). Comparisons using count data (BOP and PI) will be assessed using a GEE with a Poisson regression model. A multivariable linear regression model will be used to assess the impact of baseline defect parameters, type of defect, age, medical status and smoking on volumetric/linear ridge changes, complications and implant outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/02/2023
Actual
12/12/2022
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
15
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 35953 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 310141 0
University
Name [1] 310141 0
University of Queensland
Country [1] 310141 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
288 herston road
herston QLD 4006
Country
Australia
Secondary sponsor category [1] 311217 0
None
Name [1] 311217 0
Address [1] 311217 0
Country [1] 311217 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309831 0
University of Queensland Human Research Ethics Committee
Ethics committee address [1] 309831 0
University of Queensland
St Lucia
Queensland 4072
Ethics committee country [1] 309831 0
Australia
Date submitted for ethics approval [1] 309831 0
24/12/2021
Approval date [1] 309831 0
Ethics approval number [1] 309831 0
Ethics committee name [2] 312343 0
Uniting Health Care HREC
Ethics committee address [2] 312343 0
Level 5, 192 Ann Street
Brisbane QLD 4000
Ethics committee country [2] 312343 0
Australia
Date submitted for ethics approval [2] 312343 0
22/06/2022
Approval date [2] 312343 0
20/09/2022
Ethics approval number [2] 312343 0
UCH HREC 202211

Summary
Brief summary
The use of pre-fabricated, customized and bioresorbable medical grade scaffolds is a significant development in this field of tissue engineering. Medical grade polycaprolactone (PCL) is a highly biocompatible and completely bioresorbable polymer. These scaffolds have been shown to be dimensionally accurate and stable, adaptable to a range of defects and conducive for bone regeneration. These scaffolds, are yet to be clinically assessed clinically.

The objective of this proof of principle study is to report on the efficacy of a 3D printed custom manufactured medical grade polycaprolactone (PCL) scaffold that is loaded with anorganic bovine bone mineral (ABBM) and particulate autogenous bone (AB) in reconstruction of alveolar ridge defects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115534 0
Dr jamil alayan
Address 115534 0
The University of Queensland.
Senior lecturer
288 Herston Rd, Herston QLD 4006
Country 115534 0
Australia
Phone 115534 0
+61733658022
Fax 115534 0
Email 115534 0
[email protected]
Contact person for public queries
Name 115535 0
jamil alayan
Address 115535 0
University of Queensland
288 Herston Rd, Herston QLD 4006
Country 115535 0
Australia
Phone 115535 0
+61733658022
Fax 115535 0
Email 115535 0
[email protected]
Contact person for scientific queries
Name 115536 0
jamil alayan
Address 115536 0
University of Queensland
288 Herston Rd, Herston QLD 4006
Country 115536 0
Australia
Phone 115536 0
+61733658022
Fax 115536 0
Email 115536 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
only group data will be presented to maintain privacy of the individual praticipant


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.