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Trial registered on ANZCTR


Registration number
ACTRN12620000225910p
Ethics application status
Submitted, not yet approved
Date submitted
22/01/2020
Date registered
24/02/2020
Date last updated
24/02/2020
Date data sharing statement initially provided
24/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Success of the Rectangular Block Dental Implant in Patients with Low Bone Volume
Scientific title
The Success of the Rectangular Block Dental Implant in Patients with Resorbed Alveolar Ridges: A Clinical Trial
Secondary ID [1] 300340 0
None
Universal Trial Number (UTN)
U1111-1247-0904
Trial acronym
RBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
partial or complete edentulism 315951 0
Condition category
Condition code
Oral and Gastrointestinal 314220 314220 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
The Rectangular block Implant (RBI) possesses state of the art technology and will be the first dental implant designed and manufactured in Australia. After thorough in vitro and in vivo analysis, it has been tailored for use in humans. The RBI represents a new concept in implant design and force distribution. The specific needs addressed by this novel dental implant are:

1. Maximal utilisation of the remaining bone volume;
2. Minimisation of risk to the Inferior Alveolar Nerve (IAN) or other vital structures in or near the oral cavity;
3. Maximisation of force distribution.

This new implant is not designed to replace the plethora of dental implant designs that currently exist. It is aimed at providing a specialized implant fixture for individual clinical cases. The depth of the RBI will be 5.5mm, thereby qualifying it as a very short implant, i.e. suitable in cases of very low bone height.

The aim of this project is to validate the restorative function of the Rectangular Block Implant (RBI) in the human jaw under conditions of low bone volume.
The objectives will thus be to:
I. Surgically place the RBIs into the jawbone of patients with resorbed alveolar ridges.
II. Test the direct structural and functional connection between living bone.
III. Test the biomechanical and functional load bearing of the RBI in the oral environment.

1. Methodology
The exact placement of the RBI will be deliberated by a specialist team so that the prosthetic crowns attached to the implant will have adequate distribution of force and hence optimum functionality. A piezo-electric osteotomy shall be prepared which will require custom-made piezo-surgical instruments so that greater bone preservation and least soft tissue damage is incurred.

1.2 RBI Manufacturing
The implant componentry which will include the RBIs, cover screws, abutments, abutment screws and stem handles shall be manufactured by Phantom Engineering Limited. This process involves lathe turning and surface preparation with titanium oxide and acid etching. The implant will be packaged and sterilized at the end of this phase, ready to be transported to the clinic.

1.3 Pre-Operative Phase
A thorough clinical oral assessment will be performed followed by a Cone Beam Computerized Tomography (CBCT) to visualize the proposed surgical site in three dimensions.

1.4 Operative Phase
Local anaesthesia will be administered via long hand block and local infiltration. An incision will be made and the osteotomy site will be prepared to receive the RBI in a manner that achieves primary stability, and encapsulates the entire implant. This will be achieved using surgical guides (prefabricated to accurately assist in placement of an implant in the bone structure) as per current implant placement protocols and a specialized piezo-electric ultrasonic surgical unit (Mectron Piezosurgery, Mectron Corporation, Australia).
Consequently, a trial-fit (“dummy”) implant block will be used to gauge the size and orientation of the prepared site. Confirmation of attainment of adequate seating of the trial-fit block is a pre-requisite to proceeding with implant placement.
The osteotomy site will be debrided with saline, and a sterile RBI transported with the use of an attached stem handle and seated into the site with firm finger pressure. The placement stem handle will be removed and the block implant tapped into position using the surface purchase points and the central screw shaft opening as per the trial-fit block. A cover screw will be placed.
Soft tissue flaps will be placed over their original positions and sutures will be secured over the wounds to ensure adequate primary surgical wound closure. Antibiotics and analgesics will be prescribed post-operatively.

1.5 Post-operative
Wound maintenance instructions will include a soft diet, prescription medications and oral hygiene instructions. After-hours telephone numbers will be provided. The patient will be dismissed after the achievement of haemostasis.
The patient will be reviewed post-operatively after two weeks and suture removal will be performed. The patient will be asked to return for second stage surgery after a further 12 weeks. As per current implant protocols, the second stage of this treatment will again be under local anaesthesia. An initial surface incision will be made to expose the underlying cover screw, which will then be removed.

1.6 Assessment of Osseo-integration: Resonance Frequency Analysis
Resonance Frequency Analysis is a painless and non-invasive technique. It will be performed from mesial, distal, buccal and lingual aspects, and repeated five times. A reading of 80 or greater will be indicative of successful osseointegration. Upon successful osseointegration, a trans-mucosal healing abutment, designed to facilitate the healing process around the gingiva surrounding the implant site, will be inserted to allow soft tissue healing. This process will not require suturing.

1.7 Prosthodontic Phase
At three months post healing, impressions will be taken for the construction of the prosthetic crown. The prosthetic crown will be constructed in a laboratory: a process requiring approximately two to three weeks. The crown will then be screwed onto the abutment towards the end of this phase and checked for occlusal interferences and proper functional relationships. The patient will be instructed on proper oral hygiene maintenance generally and specifically regarding the new implant retained crown.

1.8 Follow Up and Long-Term Monitoring
The function of the implant-abutment-crown complex will be monitored at regular intervals (monthly, then three-monthly then six-monthly and then yearly) over the following five years. Specific clinical parameters will be implant stability, component stability, functional capacity and peri-implant tissue health. The patient’s personal satisfaction (rating out of 10, and general comments) will also be recorded based on previously published protocols from this group.
Successfully surviving implants will be left to function indefinitely, and a further prosthetic crowns may be needed for longer term (> 5 years) function. This is a prosthodontic painless process: it will be made using the master models made from the original impressions.

1.9 Participant Tasks
For implant surgery to commence, the first visit will include a preoperative prosthodontic assessment. In the second visit, a cone beam computed tomography (CBCT) scan performed along with dental radiographs to visualise the quality and quantity of bone present at the receiving site of the RBI. In the third visit also, a presurgical assessment will be performed. In the fourth visit will last 60 minutes and the participants shall undergo the surgical placement of RBIs. Post-operative recovery will involve the use of analgesics, antibiotics and possibly time off work. A week later, in the fifth visit, dental radiographs will be taken and periodontal assessment of implant stability via clinical assessment and RFA will be done. In the sixth and the seventh visit RFA will be performed again and implant success and survival will be assessed. The sixth visit will be three months after the RBI placement and the seventh will be after six months. Each visit will take approximately 60 minutes. The eighth visit will be at the one-year mark. RFA and dental radiographs shall be performed on this visit. Therefore: a total of approximately eight hours of chairside time will be required for each participating patient in the first year of the pilot study. Throughout the course of this study, oral hygiene measures will be reinforced and reiterated at every visit.

2. Specific Details of Intervention
The selection process of suitable patients and the consent process with the selected patients in the RBI Project will be undertaken by the A/Prof Roy Judge (Principal investigator, Head of Prosthodontics, Melbourne Dental School), Dr. Mohsin Nazir (Project Manager, PhD Student, Melbourne Dental School), and Dr. Ethemios Gazelakis (Project Supervisor, Honorary staff, Melbourne Dental School).
• The preparation of implants to be used will be the responsibility of A/Prof Roy Judge, Dr. Mohsin Nazir, Dr. Ethemios Gazelakis and A/Prof Joseph Palamara.
• The surgical pre-operative, operative and post-operative of the clinical trial will be performed by Dr. Ricky Kumar (Oral Maxillofacial Surgeon, Dental Health Services Victoria) and overseen by A/Prof Roy Judge, Dr. Mohsin Nazir, and Dr. Ethemios Gazelakis.
• The prosthodontic or reconstructive oral management of patients will be the responsibility of A/Prof Roy Judge, Dr. Mohsin Nazir, and Dr. Ethemios Gazelakis.
• The clinical data collection with respect to implant function, oral health and patient satisfaction will be overseen by A/Prof Roy Judge, Dr. Mohsin Nazir, and Dr. Ethemios Gazelakis.
• The long-term monitoring of patients (over 12 months) will be the responsibility of A/Prof Roy Judge, Dr. Mohsin Nazir, and Dr. Ethemios Gazelakis.
• The report drafting will be prepared by A/Prof Roy Judge, Dr. Mohsin Nazir, Dr. Ethemios Gazelakis, Dr. Ricky Kumar and A/Prof Joseph Palamara.
• The general study design and the publication of results will involve A/Prof Roy Judge, Dr. Mohsin Nazir, Dr. Ethemios Gazelakis, Dr. Ricky Kumar and A/Prof Joseph Palamara.

3.0 Strategies for Monitoring Fidelity
A/Prof Roy Judge will be in charge of the overall monitoring of fidelity within the study management plan. The file keeping, patient record keeping, and patient notes will be taken by Dr. Mohsin Nazir who will be in charge of managing the RBI project and reinforcing the agreed study protocol. Furthermore, the project manager will take notes, action to resolution, and report if adverse device events/serious adverse device events take place and the study protocol deserves abandonment.

4.0 The Information Brochure
The information brochure contains an introduction to RBI therapy along with the purpose of conducting a clinical trial. It describes how the RBI is apt for case-sensitive functional treatment of the resorbed alveolar ridge. Moreover, procedural information and what is required of the participant during the course of this study is discussed in detail in this document. Daily oral hygiene practice is emphasized upon and the advantages, disadvantages and complications that may arise are described in plain language. Also, the inclusion and exclusion criteria of the RBI therapy is discussed together with secure data management and legal confidentiality. The participants are provided with contact information about the personnel who will be responsible for the interventional treatment.
Intervention code [1] 316620 0
Treatment: Devices
Comparator / control treatment
No Control Group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322611 0
The primary outcomes of this study will compositely focus on implant success via the inspection of implant stability, component stability, functional capacity, and peri-implant tissue health.

Implant stability will be assessed via Resonance Frequency Analysis (RFA) and average Implant Stability Quotient (ISQ: 55-85 indicate osseointegration) value shall be recorded. Radiographs will be taken at each visit to help assess osseointegration and peri-implant bone status as well. Furthermore, peri-implant tissue health will be observed by carefully using a Michigan O probe and checking for periodontal signs of inflammation and bleeding on probing. Component stability will also be investigated via the help of reverse torque wrenches to check the loss of torque and screw loosening at regular intervals during follow up visits. Functional capacity of the implant–prosthesis system shall be assessed at every visit by observing signs of wear and maintenance of occlusion during function.
Timepoint [1] 322611 0
RFA (ISQ Value)- 3 months, 6 months, 1 year (Primary Timepoint), 1.5 years, 2 years, every six months till 5 years. Annually after 5 years. The implant will be left inside the oral cavity indefinitely to function.

Peri-implant tissue health: pre operative, operative, post operative 3 months, 6 months, 1 year (Primary Timepoint), 1.5 years, 2 years, every six months till 5 years. Annually after 5 years. The implant will be left inside the oral cavity indefinitely to function and oral tissue health will be monitored at every visit.

Component stability - immediately post-operatively, 3 months, 6 months, 1 year (Primary Timepoint), 1.5 years, 2 years, every six months till 5 years. Annually after 5 years. The implant will be left inside the oral cavity indefinitely to function and component stability will be monitored at every visit.

Functional capacity: 3 months, 6 months, 1 year (Primary Timepoint), 1.5 years, 2 years, every six months till 5 years. Annually after 5 years. The implant will be left inside the oral cavity indefinitely to function.
Secondary outcome [1] 379040 0
The Clinician's personal satisfaction will be recorded through a specially designed questionnaire template and through medical notes that will be taken by the Project Manager of the RBI team.
Timepoint [1] 379040 0
Clinician's personal satisfaction with the RBI therapy - immediately post-operatively, 3 months, 6 months, 1 year (Secondary Timepoint), 1.5 years, 2 years, every six months till 5 years. Annually after 5 years.
Secondary outcome [2] 379466 0
The patient's personal satisfaction will be also recorded through a specially designed questionnaire template and through medical notes that will be taken by the Project Manager of the RBI team.
Timepoint [2] 379466 0
Patient personal satisfaction with the RBI therapy - immediately post-operatively, 3 months, 6 months, 1 year (Secondary Timepoint), 1.5 years, 2 years, every six months till 5 years. Annually after 5 years.

Eligibility
Key inclusion criteria
- Inability to undergo conventional implant therapy without bone grafting or surgical bone augmention
- Minimum 8mm (mesiodistal) x 6mm (buccolingual) x 6mm (vertical) bone.
- A history of inability to wear removable dentures
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Uncontrolled diabetes,
• Adrenal insufficiency,
• Cushing’s disease,
• Hyperthyroidism,
• Hypothyroidism,
• Hypertension,
• Rheumatoid arthritis,
• Bleeding and coagulation disorders,
• Untreated neoplasia,
• Chemotherapy and radiotherapy within the last 5 years.
• Pregnancy,
• Presence of advanced periodontal disease.
• Smoking
• Illicit drug usage.
• Pharmacological agents which complicate implant therapy, for example:
Bisphosphonates and Prolia.
[This list is intended to be indicative only and is not exhaustive]

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)
Allocation not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple tabulated randomisation
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
All clinical records (including X-rays, questionnaires and clinical examinations), will be
collated to yield an understanding of the clinical effectiveness of the RBI therapy. The
questionnaire based subjective assessment of the patients regarding the effectiveness of the
treatment in the improvement of function, as well the clinical parameters in the assessment of the implants’ success will be recorded. In the latter category, implant stability (RFA analysis), peri-implant tissue health and maintenance will be assessed clinically. This data will be quantitatively analysed through the SPSS Software. Since this will be a pilot: a preliminary
evaluation of the success of implant therapy with the RBI, a small sample of 10 participants
has been deemed an adequate allocation for this study (as per discussions with Prof. Rodrigo
Marino, Melbourne Dental School). Results here will further inform a later international
multicentre study, where larger participant numbers will be mandated. This pilot study will
be run on the basis of convenience sampling and therefore a power of analysis is not warranted.
Notwithstanding this, planned later international multicentre clinical trials will yield results
with higher powers of analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15673 0
The Royal Dental Hospital of Melbourne - Carlton
Recruitment postcode(s) [1] 29089 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 304765 0
University
Name [1] 304765 0
The University of Melbourne - POC grant
Address [1] 304765 0
720 Swanston street, Carlton, VIC 3053
Country [1] 304765 0
Australia
Funding source category [2] 304770 0
Other Collaborative groups
Name [2] 304770 0
Biomedical Translational Bridge (BTB) Grant
Address [2] 304770 0
Level 20,
15 William Street
Melbourne VIC 3000
Country [2] 304770 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
720 Swanston street, Carlton, VIC 3053
Country
Australia
Secondary sponsor category [1] 305079 0
Other Collaborative groups
Name [1] 305079 0
Biomedical Translational Bridge (BTB) Grant
Address [1] 305079 0
Level 20,
15 William Street
Melbourne VIC 3000
Country [1] 305079 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305182 0
The University of Melbourne - Medicine and Dentistry HESC
Ethics committee address [1] 305182 0
720 swanston street, carlton, Vic, 3053
Ethics committee country [1] 305182 0
Australia
Date submitted for ethics approval [1] 305182 0
21/11/2019
Approval date [1] 305182 0
Ethics approval number [1] 305182 0
1955302

Summary
Brief summary
The RBI represents a new concept in dental implant design. The specific needs addressed by this novel dental implant are: (i) maximal utilisation of the remaining bone volume; (ii) minimisation of risk to the Inferior Alveolar Nerve (IAN) or other vital structures in or near the oral cavity; and (iii) maximisation of force distribution. It is aimed at providing a specialized dental implant fixture for complex clinical cases with minimal chairside time and surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99518 0
A/Prof Roy Judge
Address 99518 0
The University of Melbourne,
Melbourne Dental School,
Level 5, 720 swanston street,
Carlton VIC, 3053
Melbourne, Australia.
Country 99518 0
Australia
Phone 99518 0
+61 39341 1531
Fax 99518 0
Email 99518 0
roybj@unimelb.edu.au
Contact person for public queries
Name 99519 0
A/Prof Roy Judge
Address 99519 0
The University of Melbourne,
Melbourne Dental School,
Level 5, 720 swanston street,
Carlton VIC, 3053
Melbourne, Australia.
Country 99519 0
Australia
Phone 99519 0
+61 39341 1531
Fax 99519 0
Email 99519 0
roybj@unimelb.edu.au
Contact person for scientific queries
Name 99520 0
A/Prof Roy Judge
Address 99520 0
The University of Melbourne,
Melbourne Dental School,
Level 5, 720 swanston street,
Carlton VIC, 3053
Melbourne, Australia.
Country 99520 0
Australia
Phone 99520 0
+61 39341 1531
Fax 99520 0
Email 99520 0
roybj@unimelb.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
It is intended that the results of the study be published in appropriate peer reviewed medical journals. These are available to anyone on-line. The results will also be presented at relevant professional seminars which are advertised and indeed open to all to attend. Media invitations may also be considered depending on the nature of the results. Regarding discussing research findings in the public arena, these will not occur until the findings have been tested through peer review. In discussing the outcomes of the research project, special care will be taken to explain the status of the project — for example, whether it is still in progress or has been finalised. Care will be taken such that the outcomes of the research will be presented to any sponsors or entities with financial interests, prior to public dissemination. A/Prof Roy Judge shall be in charge of monitoring the dissemination of the information from the results of this study. The participants shall remain anonymous in the reporting of this study. Care will be taken to maintain the confidentiality of each participant. This will commence by insulating the specific cohort of patients from the remaining general patient population. Specific clinics will be established for this cohort, and all staff allocated to assist directly and indirectly in this clinic will be appropriately briefed on the requirements of patient privacy and confidentiality. Record keeping for patients at the Royal Dental Hospital are subject to the provisions of privacy and confidentiality protocols embodied by the codes of Dental Health Services Victoria (DHSV). The records of each patient will further be kept within the research unit itself, on the fifth floor of the Hospital: Head of Prosthodontics, A/Prof Roy Judge. Access to this database will be strictly restricted to only those that are officially registered within the unit’s research team. All data will be in digital form: X-rays, models, photographs, written notes, scanned consent forms and any other necessary signed forms. Individual patients will be assigned a coded number which will be identifiable only by those having access to the main database.
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 6551 0
Study protocol
Citation [1] 6551 0
Link [1] 6551 0
Email [1] 6551 0
Other [1] 6551 0
Type [2] 6552 0
Informed consent form
Citation [2] 6552 0
Link [2] 6552 0
Email [2] 6552 0
Other [2] 6552 0
Summary results
No Results