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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
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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
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Secondary ID [1]
313233
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
alveolar ridge deficiency
335534
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Condition category
Condition code
Surgery
332106
332106
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0
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Surgical techniques
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Oral and Gastrointestinal
332105
332105
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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).
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Intervention code [1]
329813
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Treatment: Devices
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Intervention code [2]
329940
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Treatment: Surgery
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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graft volumetric gain
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Assessment method [1]
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Radiographic overlay (CT scans) - the original defect volume is measured from the pre-regeneration of new bone CT1 and then pre-placement of dental implant CT2 following regeneration allows calculation of absolute graft volume gain and regenerated fraction
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Timepoint [1]
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Baseline and 8 months post-alveolar ridge augmentation
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Secondary outcome [1]
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Peri-implant tissue status - gingival inflammation
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Assessment method [1]
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clinical assessment - visual inspection. This will be recorded in a case report form.
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Timepoint [1]
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delivery prosthesis (14 weeks post-implant placement) and 12 months after delivery of prosthesis
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Secondary outcome [2]
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Implant feasibility
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Assessment method [2]
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digital overlay technique utilizing digital implant software analysis
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Timepoint [2]
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baseline (pre-alveolar ridge augmentation) compared to 12 weeks after implant placement (approx 11 months after ridge augmentation)
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Secondary outcome [3]
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Implant stability
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Assessment method [3]
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Resonance frequency measurements - is a measure of dental implant stability in bone. This is presented as a numerical value on the implant stability quotient / scale (range 1-99).
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Timepoint [3]
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At implant placement (approximately 8 months after alveolar ridge augmentation) and at 12 weeks post-implant placement.
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Secondary outcome [4]
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Time to recovery after dental implant placement surgery
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Assessment method [4]
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visual analogue scale, oral health related quality questionnaire (LIkert scale)
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Timepoint [4]
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daily for the 1st 14 days immediately after dental implant placement surgery
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Secondary outcome [5]
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Implant feasibility
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Assessment method [5]
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clinical - direct assessment by examining actual implant position with planned position translated to the clinic using a static surgical guide.
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Timepoint [5]
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At implant placement (approx 8 months after alveolar ridge augmentation)
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Secondary outcome [6]
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Perception difficulty of surgery during alveolar ridge augmentation surgery
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Assessment method [6]
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visual analogue scale
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Timepoint [6]
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immediately after alveolar ridge augmentation surgery
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Secondary outcome [7]
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Perception pain during alveolar ridge augmentation surgery
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Assessment method [7]
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visual analogue scale
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Timepoint [7]
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immediately after alveolar ridge augmentation surgery
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Secondary outcome [8]
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Peri-implant tissue assessment - bleeding on probing
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Assessment method [8]
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Fraction of sites that bleed upon probing /total of 6 sites per dental implant
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Timepoint [8]
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delivery prosthesis (14 weeks post-implant placement) and 12 months after delivery of prosthesis
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Secondary outcome [9]
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Time to recovery after after alveolar ridge augmentation surgery
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Assessment method [9]
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visual analogue scale, oral health related quality questionnaire (LIkert scale)
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Timepoint [9]
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daily for the 1st 14 days immediately after alveolar ridge augmentation surgery
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Secondary outcome [10]
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Perception difficulty of surgery during implant placement surgery
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Assessment method [10]
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visual analogue scale
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Timepoint [10]
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immediately after implant placement surgery
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Secondary outcome [11]
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Dental implant stability
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Assessment method [11]
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Resonance frequency measurements - is a measure of dental implant stability in bone. This is presented as a numerical value on the implant stability quotient / scale (range 1-99).
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Timepoint [11]
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12 weeks post-implant placement
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Secondary outcome [12]
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Linear bone changes
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Assessment method [12]
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Radiographic overlay (CT scans) - the original defect is measured from the pre-regeneration of new bone CT1 and then pre-placement of dental implant CT2 following regeneration allows calculation of absolute linear graft gain
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Timepoint [12]
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Baseline and 8 months post-alveolar ridge augmentation
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Secondary outcome [13]
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Perception pain during implant placement surgery
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Assessment method [13]
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visual analogue scale
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Timepoint [13]
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immediately after dental implant placement surgery
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Secondary outcome [14]
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Post-operative morbidity after alveolar ridge augmentation
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Assessment method [14]
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Clinical assessment - visual inspection. This will be recorded in a case report form.
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Timepoint [14]
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1, 2 and 8 weeks after ridge augmentation surgery
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Secondary outcome [15]
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Histological assessment
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Assessment method [15]
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Histomorphometry
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Timepoint [15]
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8 months after alveolar ridge augmentation
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Secondary outcome [16]
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Status of Implant-supported restorations
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Assessment method [16]
440929
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clinical assessment - visual inspection. This will be recorded in a case report form.
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Timepoint [16]
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delivery prosthesis (14 weeks post-implant placement) and 12 months after delivery of prosthesis
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Secondary outcome [17]
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Peri-implant marginal bone status
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Assessment method [17]
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Radiographic measurement of 1st bone to implant contact
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Timepoint [17]
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delivery prosthesis (14 weeks post-implant placement) and 12 months after delivery of prosthesis
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Secondary outcome [18]
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Patient Satisfaction of overall treatment
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Assessment method [18]
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condition specific health related quality questionnaire
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Timepoint [18]
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delivery prosthesis (14 weeks post-implant placement) and 12 months after delivery of prosthesis
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Secondary outcome [19]
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Peri-implant tissue status - probing depth
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Assessment method [19]
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mean probing depth (mm) from a total of probing 6 sites per dental implant
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Timepoint [19]
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delivery prosthesis (14 weeks post-implant placement) and 12 months after delivery of prosthesis
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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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random permuted blocks
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
6/03/2025
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Actual
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Date of last participant enrolment
Anticipated
5/03/2026
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Actual
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Date of last data collection
Anticipated
7/04/2028
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment outside Australia
Country [1]
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Spain
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State/province [1]
26647
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madrid
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Oral Reconstruction Foundation
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Address [1]
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Country [1]
317675
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Switzerland
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Primary sponsor type
University
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Name
University of Queensland
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
319993
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Country [1]
319993
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316374
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The University of Queensland Human Research Ethics Committee B
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Ethics committee address [1]
316374
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https://www.uq.edu.au/research/research-support/ethics-integrity-and-compliance/human-ethics
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Ethics committee country [1]
316374
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Australia
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Date submitted for ethics approval [1]
316374
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17/08/2024
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Approval date [1]
316374
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31/08/2024
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Ethics approval number [1]
316374
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2024/HE000227
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Summary
Brief summary
The objective of this randomized controlled clinical trial is to compare the efficacy of a patient specific 3D-printed manufactured medical grade polycaprolactone mesh with a collagen membrane that are loaded with particulate anorganic porcine bone mineral and autogenous bone in the reconstruction of alveolar ridge defects. Lay public hypothesis: We anticipate no significant differences when using customized 3D-printed polymer (polycaprolactone) mesh or the current technique of using animal derived collagen membranes trimmed chair-side to reconstruct lost jaw bone. The trial will report results for a extensive range of outcomes including; graft volume, post-operative recovery/morbidity, implant feasibility, histology, peri-implant parameters and patient reported outcomes
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Jamil Alayan
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Address
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Level 6 (Research Laboratory) at the Oral Health Centre, 288 Herston Rd, Herston QLD 4006
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Country
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Australia
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Phone
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+61413121507
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Fax
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Email
137694
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[email protected]
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Contact person for public queries
Name
137695
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Jamil Alayan
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Address
137695
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Level 6 (Research Laboratory) at the Oral Health Centre, 288 Herston Rd, Herston QLD 4006
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Country
137695
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Australia
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Phone
137695
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+61413121507
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Fax
137695
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Email
137695
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[email protected]
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Contact person for scientific queries
Name
137696
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Jamil Alayan
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Address
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Level 6 (Research Laboratory) at the Oral Health Centre, 288 Herston Rd, Herston QLD 4006
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Country
137696
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Australia
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Phone
137696
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+61413121507
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Fax
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Email
137696
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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.
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