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Trial registered on ANZCTR


Registration number
ACTRN12618000622202
Ethics application status
Approved
Date submitted
5/04/2018
Date registered
20/04/2018
Date last updated
10/12/2020
Date data sharing statement initially provided
10/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
For replacing a single missing tooth with implant, is there a difference between the traditional and the new techniques for placing implants in relation to accuracy and restoration longevity
Scientific title
The effect of different implant placement protocols on the accuracy, and surgical and restorative outcomes of single implants for patients requiring single tooth replacement: Comparative study of two computer-planned and guided implant placement protocols and traditional implant placement protocol
Secondary ID [1] 294507 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Restoration of single tooth dental implants 307278 0
Condition category
Condition code
Oral and Gastrointestinal 306396 306396 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
Two different computer-based surgical guides will be used and tested: full guides and partial guides. These guides are based on computer 3D analysis of jaw bone and digitally planning for ideal implant position. Each patient will receive a cone beam CT scan of the implant site. The scan is a standard procedure required for implant planning, and every patient from the intervention and control groups will receive the same scan. The different surgical guide types are produced differently in the laboratories, and there will be no additional clinical appointment or involvement for the participating patients.

According to the ideal implant position, surgical guides will be produced by 3D printing. The full guides are related to an international implant company that designs (via commercial software) and produces surgical guides to control all the surgical steps and implant placement.

The partial guides are designed by an open source software and produced by commercial laboratories. The partial guides control only the first step of implant surgery, which is the pilot bone drilling. This step is completed only by one drill (pilot drill), and the generated bone hole will be used to guide the rest of the bone drills without the use of the guide.

Each implant will be randomly allocated to one of the test guides or the traditional guide. The implant surgery normally takes about 1 to 2 hours.

All the surgical and restorative steps will be completed under supervision of periodontics and prosthodontics dental specialists who are familiar with all the implant placement protocols. To standardize the treatment, the involved clinicians will be calibrated and will follow a data collection form to ensure consistent data gathering for each step of treatment.
Intervention code [1] 300801 0
Treatment: Devices
Comparator / control treatment
The control will be traditional guides that are designed and produced by commercial dental laboratory without software use. The dental laboratory use physical dental cast of the patient to fabricate a guide that controls implant placement. The traditional guides are the current guides used at Melbourne Dental School and other teaching institutions, and constitute the minimal requirements for any implant surgery.
Control group
Active

Outcomes
Primary outcome [1] 305410 0
Ease of use of different guides by operator (clinician).

The ease of use of each guide will be evaluated by operator's experience questionnaire (designed specifically for this study) in the form of visual analogue scale, and reporting any form of necessary guide adjustment.
Timepoint [1] 305410 0
Immediately following the implant surgery.
Primary outcome [2] 305411 0
Duration of implant surgery.

The duration of implant surgery will be recorded in minutes.
Timepoint [2] 305411 0
Immediately following the implant surgery.
Primary outcome [3] 305506 0
Implant restoration survival in the form of incidence of complications (biological and mechanical). The complications can be peri-implant soft tissue inflammation, discoloration of peri-implant soft tissue, loosening of restoration screw, chipping of ceramic restoration and restoration fracture. These complications can be detected by visual inspection of the soft tissue and the restoration, routine radiographic evaluation and palpation of the restoration.

The incidence will be recorded in percentage (%).
Timepoint [3] 305506 0
Baseline: immediately after restoring the implant
1st follow-up (primary timepoint): 2-4 weeks after restoring the implant
1st recall visit: 1 year after implant restoration
2nd recall visit: 2 years after implant restoration (endpoint of the study)
Secondary outcome [1] 345094 0
Precision of placed implants in comparison to the planned implant position. Measured in mm.
Note: This step is a laboratory procedure and will not influence the clinical treatment. It is based on taking an implant impression, which is a necessary step for the restoration fabrication. From the impression, a cast will be produced and will be used to evaluate the precision of the placed implant.
Timepoint [1] 345094 0
Precision of placed implants will be assessed at the time of implant impression for restoration fabrication. This will happen after 3 months of implant surgery.
Secondary outcome [2] 345513 0
Restoration aesthetics will be rated as acceptable on not acceptable by patient.
Timepoint [2] 345513 0
Baseline and 2-4 weeks, 1 year and 2 years after implant restoration
Secondary outcome [3] 345514 0
Restoration aesthetics will be rated as acceptable on not acceptable by clinician.
Timepoint [3] 345514 0
Baseline and 2-4 weeks, 1 year and 2 years after implant restoration
Secondary outcome [4] 345515 0
Restoration accuracy will be rated as accurately fitting, requiring minor adjustment, requiring major adjustment or misfitting.
Timepoint [4] 345515 0
At the time of implant restoration, which will happen after 3 months of implant surgery.
Secondary outcome [5] 345516 0
Patient satisfaction of the treatment will be rated via visual analogue scale.
Timepoint [5] 345516 0
Baseline and 2-4 weeks, 1 year and 2 years after implant restoration
Secondary outcome [6] 345779 0
Clinician satisfaction of the treatment will be rated via visual analogue scale.
Timepoint [6] 345779 0
Baseline and 2-4 weeks, 1 year and 2 years after implant restoration
Secondary outcome [7] 345780 0
Soft tissue response will be evaluated by composite measurements of the probing pocket depth (mm), bleeding on probing (present or absent) and metallic discoloration (present or absent).
The probing depth and bleeding on probing will be assessed by periodontal probe. The metallic discoloration will be assessed by visual inspection of the peri-implant soft tissue.
Timepoint [7] 345780 0
2-4 weeks, 1 year and 2 years after implant restoration

Eligibility
Key inclusion criteria
Single implant
Minimum of 20 functional teeth
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Requirement for major or block grafting
Head or neck radiation in previous 12 months
Metabolic bone disease
Severe parafunction
Uncontrolled diabetes
Smoker
Pregnancy

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)
Following informed consent and fulfillment of inclusion/exclusion criteria, patients will be sequentially allocated a treatment ID code. Once a treatment ID has been allocated, the treating clinician will be issued a sealed envelope marked with that treatment ID containing a centrally generated treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation is via computer-generated schedule using 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
Recruiting
Date of first participant enrolment
Anticipated
3/09/2018
Actual
3/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
23
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10573 0
The Royal Dental Hospital of Melbourne - Carlton
Recruitment postcode(s) [1] 22292 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 299132 0
University
Name [1] 299132 0
Internal Grants; Melbourne University
Country [1] 299132 0
Australia
Primary sponsor type
University
Name
Melbourne University
Address
Melbourne Dental School
Melbourne University
720 Swanston Street
Carlton
VIC 3053
Country
Australia
Secondary sponsor category [1] 298392 0
None
Name [1] 298392 0
None
Address [1] 298392 0
None
Country [1] 298392 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300064 0
Melbourne Dental School Human Ethics Advisory Group
Ethics committee address [1] 300064 0
Ethics committee country [1] 300064 0
Australia
Date submitted for ethics approval [1] 300064 0
26/03/2018
Approval date [1] 300064 0
22/06/2018
Ethics approval number [1] 300064 0
1851576

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

Contacts
Principal investigator
Name 82442 0
Dr Jaafar Abduo
Address 82442 0
Melbourne Dental School
Melbourne University
720 Swanston Street
Carlton
VIC 3053
Country 82442 0
Australia
Phone 82442 0
+61 3 90358998
Fax 82442 0
Email 82442 0
jaafar.abduo@unimelb.edu.au
Contact person for public queries
Name 82443 0
Jaafar Abduo
Address 82443 0
Melbourne Dental School
Melbourne University
720 Swanston Street
Carlton
VIC 3053
Country 82443 0
Australia
Phone 82443 0
+61 3 90358998
Fax 82443 0
Email 82443 0
jaafar.abduo@unimelb.edu.au
Contact person for scientific queries
Name 82444 0
Jaafar Abduo
Address 82444 0
Melbourne Dental School
Melbourne University
720 Swanston Street
Carlton
VIC 3053
Country 82444 0
Australia
Phone 82444 0
+61 3 90358998
Fax 82444 0
Email 82444 0
jaafar.abduo@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


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.