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Trial registered on ANZCTR


Registration number
ACTRN12625000122459
Ethics application status
Approved
Date submitted
22/10/2024
Date registered
3/02/2025
Date last updated
3/02/2025
Date data sharing statement initially provided
3/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Regenerating lost jaw bone using patient specific 3D-printed resorbable polycaprolactone mesh versus a resorbable collagen membrane
Scientific title
A randomized controlled clinical trial evaluating the efficacy of a patient specific 3D-printed resorbable polycaprolactone mesh versus a resorbable collagen barrier membrane in guided bone regeneration
Secondary ID [1] 313233 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
alveolar ridge deficiency 335534 0
Condition category
Condition code
Oral and Gastrointestinal 332105 332105 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 332106 332106 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial compare effectiveness of the using a 3D printed patient specific polycaprolactone (PCL) (test) mesh versus a collagen membrane (control) when combined with a a composite graft composed of particulate anorganic porcine bone mineral (APBM) and autogenous bone (AB) in a 1:1 ratio for alveolar ridge augmentation (replacing lost jaw bone).

What occurs during these interventions:
There are two surgical interventions. The first is alveolar ridge augmentation, which is performed to reconstruct the lost jaw bone required for dental implant placement. This surgery will be performed by experienced specialist clinicians (Periodontists) with more than 17 years experience in complex alveolar bone reconstructive surgery. The procedure involves achieving access to the bone defect via a mucoperiosteal flap. Autogenous bone harvesting is performed from the retro-molar region and mixed with porcine bone mineral then loaded into the defect and covered using a patient specific 3D printed polymer (PCL) scaffold (test group) or a collagen membrane (control). This is secured to the jaw bone then covered by the flap. Surgery will be performed in a private practice and will be 90-120min in duration. The second intervention takes place 8 months later, and takes approximately 1 hour to complete. It involves elevating a mucoperiosteal flap then creating an osteotomy of specific dimensions to allow the placement of the dental implant. The flap is then replaced and allowed to heal for a further 12 weeks before the patient continues the prosthetic phase of treatment with their referring clinicians independent of the study.

Adherence to intervention will be assessed by reviewing completed case report forms (CRFs).
Intervention code [1] 329813 0
Treatment: Devices
Intervention code [2] 329940 0
Treatment: Surgery
Comparator / control treatment
Arm 1 - Control group - receive a composite graft composed of particulate anorganic porcine bone mineral (APBM) and autogenous bone (AB) in a 1:1 ratio covered using collagen barrier membrane.
The procedure involves achieving access to the bone defect via a mucoperiosteal flap. Autogenous bone harvesting is performed from the retro-molar region and mixed with porcine bone mineral then loaded into the defect and covered using a collagen membrane. This is secured to the jaw bone then covered by the flap.
Control group
Active

Outcomes
Primary outcome [1] 339696 0
graft volumetric gain
Timepoint [1] 339696 0
Baseline and 8 months post-alveolar ridge augmentation
Secondary outcome [1] 440919 0
Linear bone changes
Timepoint [1] 440919 0
Baseline and 8 months post-alveolar ridge augmentation
Secondary outcome [2] 440920 0
Implant stability
Timepoint [2] 440920 0
At implant placement (approximately 8 months after alveolar ridge augmentation) and at 12 weeks post-implant placement.
Secondary outcome [3] 440921 0
Post-operative morbidity after alveolar ridge augmentation
Timepoint [3] 440921 0
1, 2 and 8 weeks after ridge augmentation surgery
Secondary outcome [4] 440922 0
Implant feasibility
Timepoint [4] 440922 0
At implant placement (approx 8 months after alveolar ridge augmentation)
Secondary outcome [5] 440923 0
Implant feasibility
Timepoint [5] 440923 0
baseline (pre-alveolar ridge augmentation) compared to 12 weeks after implant placement (approx 11 months after ridge augmentation)
Secondary outcome [6] 440924 0
Perception pain during alveolar ridge augmentation surgery
Timepoint [6] 440924 0
immediately after alveolar ridge augmentation surgery
Secondary outcome [7] 440925 0
Time to recovery after after alveolar ridge augmentation surgery
Timepoint [7] 440925 0
daily for the 1st 14 days immediately after alveolar ridge augmentation surgery
Secondary outcome [8] 440926 0
Histological assessment
Timepoint [8] 440926 0
8 months after alveolar ridge augmentation
Secondary outcome [9] 440927 0
Peri-implant tissue status - gingival inflammation
Timepoint [9] 440927 0
delivery prosthesis (14 weeks post-implant placement) and 12 months after delivery of prosthesis
Secondary outcome [10] 440928 0
Peri-implant marginal bone status
Timepoint [10] 440928 0
delivery prosthesis (14 weeks post-implant placement) and 12 months after delivery of prosthesis
Secondary outcome [11] 440929 0
Status of Implant-supported restorations
Timepoint [11] 440929 0
delivery prosthesis (14 weeks post-implant placement) and 12 months after delivery of prosthesis
Secondary outcome [12] 440930 0
Patient Satisfaction of overall treatment
Timepoint [12] 440930 0
delivery prosthesis (14 weeks post-implant placement) and 12 months after delivery of prosthesis
Secondary outcome [13] 441648 0
Dental implant stability
Timepoint [13] 441648 0
12 weeks post-implant placement
Secondary outcome [14] 441649 0
Perception pain during implant placement surgery
Timepoint [14] 441649 0
immediately after dental implant placement surgery
Secondary outcome [15] 441650 0
Time to recovery after dental implant placement surgery
Timepoint [15] 441650 0
daily for the 1st 14 days immediately after dental implant placement surgery
Secondary outcome [16] 441651 0
Peri-implant tissue assessment - bleeding on probing
Timepoint [16] 441651 0
delivery prosthesis (14 weeks post-implant placement) and 12 months after delivery of prosthesis
Secondary outcome [17] 441652 0
Peri-implant tissue status - probing depth
Timepoint [17] 441652 0
delivery prosthesis (14 weeks post-implant placement) and 12 months after delivery of prosthesis
Secondary outcome [18] 442259 0
Perception difficulty of surgery during alveolar ridge augmentation surgery
Timepoint [18] 442259 0
immediately after alveolar ridge augmentation surgery
Secondary outcome [19] 442260 0
Perception difficulty of surgery during implant placement surgery
Timepoint [19] 442260 0
immediately after implant placement surgery

Eligibility
Key inclusion criteria
1. Individuals aged between 18 and 65 years, medically healthy or with mild controlled systemic disease, able to undergo oral surgical procedures under local or general anaesthesia
2. Adequate plaque control (FM plaque and BOP scores less than or equal to 25%) at study baseline
3. Dental implant placement replacing 1-4 teeth in a partially dentate patient
4. Horizontal alveolar ridge deficiency preventing dental implant placement in a prosthetically driven position or with an unstable defect morphology necessitating staged bone augmentation (class-3, 4)
5. If bilateral ridge augmentation is required, only one ridge will be randomly selected and used for the purposes of this study
6. Teeth at the surgical site which require removal are extracted a minimum of 12 weeks prior to ridge augmentation
7. Adequate soft tissue profile for staged ridge augmentation. This includes a minimum zone of 2mm of keratinized gingival tissue at the buccal aspect of the surgical zone and adequate tissue thickness. Thickness is assessed by transparency of periodontal probe through the gingival margin of the adjacent teeth. Inadequate tissue parameters can be repaired prior to trial participation.
8. Treated and stable periodontal disease as assessed by specialist Periodontists with stability defined as having a full mouth bleeding score of less than or equal to 20% and no sites of residual periodontal probing depth less than or equal to 5mm
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy at the time of recruitment
2. Alcoholism or chronic drug abuse
3. Patients who smoke more than 10 cigarettes per day
4. Medications or pathology which interferes with bone formation
5. History of local radiation therapy
6. Severe parafunction
7. Extensive metallic restorations in region of interest especially post-core restorations
8. Presence of dental implant adjacent to region of interest
9. Oral mucosal disease such as Lichen Planus

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random permuted blocks
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/03/2025
Actual
Date of last participant enrolment
Anticipated
5/03/2026
Actual
Date of last data collection
Anticipated
7/04/2028
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment outside Australia
Country [1] 26647 0
Spain
State/province [1] 26647 0
madrid

Funding & Sponsors
Funding source category [1] 317675 0
Charities/Societies/Foundations
Name [1] 317675 0
Oral Reconstruction Foundation
Country [1] 317675 0
Switzerland
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 319993 0
None
Name [1] 319993 0
Address [1] 319993 0
Country [1] 319993 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316374 0
The University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 316374 0
Ethics committee country [1] 316374 0
Australia
Date submitted for ethics approval [1] 316374 0
17/08/2024
Approval date [1] 316374 0
31/08/2024
Ethics approval number [1] 316374 0
2024/HE000227

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

Contacts
Principal investigator
Name 137694 0
Dr Jamil Alayan
Address 137694 0
Level 6 (Research Laboratory) at the Oral Health Centre, 288 Herston Rd, Herston QLD 4006
Country 137694 0
Australia
Phone 137694 0
+61413121507
Fax 137694 0
Email 137694 0
j.alayan@uq.edu.au
Contact person for public queries
Name 137695 0
Jamil Alayan
Address 137695 0
Level 6 (Research Laboratory) at the Oral Health Centre, 288 Herston Rd, Herston QLD 4006
Country 137695 0
Australia
Phone 137695 0
+61413121507
Fax 137695 0
Email 137695 0
j.alayan@uq.edu.au
Contact person for scientific queries
Name 137696 0
Jamil Alayan
Address 137696 0
Level 6 (Research Laboratory) at the Oral Health Centre, 288 Herston Rd, Herston QLD 4006
Country 137696 0
Australia
Phone 137696 0
+61413121507
Fax 137696 0
Email 137696 0
j.alayan@uq.edu.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.