Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000707763
Ethics application status
Approved
Date submitted
29/04/2022
Date registered
17/05/2022
Date last updated
30/05/2022
Date data sharing statement initially provided
17/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Analysis of bacterial formation, composition and growth on implant temporary crown
Scientific title
In vivo analysis of undisturbed biofilm formation, composition and growth on implant abutment restorative materials using a novel implant-supported biofilm device
Secondary ID [1] 307029 0
None
Universal Trial Number (UTN)
U1111-1277-8569
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peri-implant infection/diseases 326172 0
Dental implant infection 326239 0
Condition category
Condition code
Oral and Gastrointestinal 323480 323480 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
- An implant-supported biofilm device will be fabricated using Computer Aided Design-Computer Aided manufacturing (CAD-CAM) and will be designed in a way where a disk can be inserted inside a chamber. The chamber will also consist of a channel that is directed and opens into the sulcular and marginal (interproximal) region in order to allow gingival crevicular fluid, saliva, and substrate to flow into the chamber.
- Disks of five different restorative materials (titanium, zirconia, gold, dental ceramic, and polymeric material (Polymethylmethacrylate (PMMA) or Polyetheretherketone (PEEK)) will be fabricated and mounted in the chamber.
- Biofilm will be allowed to grow on each material for 14-days in a cross-over design where the first disk will be removed and then the following one will be inserted and so on. The order in which the five materials are inserted into the five participants will be randomised.
- Confocal laser microscopy will be used to analyse the architecture and viability of the biofilm grown on the disks. Next-generation sequencing will be performed to analyse and compare the bacterial composition of this chamber grown biofilm on the different implant abutments restorative materials

The observational study description:
- The overall duration of observation will be 2 weeks for each Disk (each material)
- At the first visit, participants will have the implant-supported biofilm device inserted with the first disk, anticipated to take 1 hour. Subsequent visits will involve removal of the previous disk and replacement with the next randomised disk, this is anticipated to take 30-60 minutes
- No imaging or other dental assessments will be carried out during study visits
- A registered dentist will conduct the disks insertion and removal
- The study will take place at Sydney Dental Hospital, Periodontics Department.
- No wash out period between the different disks is needed
-The overall duration of observation will be at least 10 weeks
Intervention code [1] 323479 0
Not applicable
Comparator / control treatment
The control material is Titanium which is the most commonly used implant abutment material
Control group
Active

Outcomes
Primary outcome [1] 331221 0
The primary outcome is biofilm formation in an implant-supported biofilm device on different implant abutments restorative materials using confocal laser microscopy.
Timepoint [1] 331221 0
2 weeks post-insertion of each disk type for up to 5 disks.
Primary outcome [2] 331293 0
Analysis of its undisturbed 3-dimensional architecture using confocal laser microscopy,
Timepoint [2] 331293 0
2 weeks post-insertion of each disk type for up to 5 disks.
Secondary outcome [1] 409231 0
Microbiological composition of the biofilm grown in an implant-supported biofilm device on the different implant abutments restorative materials using Next Generation sequencing
Timepoint [1] 409231 0
2 weeks post-insertion of each disk type for up to 5 disks.

Eligibility
Key inclusion criteria
The inclusion criteria for the potential participants include:
• Adults aged 21 years and more that are suitable for dental implants treatment or have received already an implant that needs to be restored in the posterior region (non-esthetic sites).
• Medically healthy without any active dental or periodontal diseases.
• Good oral hygiene assessed by a full-mouth bleeding and plaque score.
• Participants need to be willing to provide informed consent and willing to participate and comply with the study requirements.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Participants that are not eligible for dental implant treatment. Absolute contraindications to dental implant treatment include recent myocardial infarction and cerebrovascular accident, valvular prosthesis surgery, immunosuppression, bleeding issues, active treatment of malignancy, drug abuse, psychiatric illness, and intravenous bisphosphonate use (Hwang & Wang, 2006).
• Participants with failing/compromised implants or peri-implantitis.
• Implant sites located in aesthetic zones, and sites that require tissue augmentation / grafting.
• Pregnant/lactating patients
• Antibiotic therapy in the last 3 months.
• Completely edentulous patients

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37453 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 311341 0
Self funded/Unfunded
Name [1] 311341 0
Fady Bassily
Country [1] 311341 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 312719 0
None
Name [1] 312719 0
Address [1] 312719 0
Country [1] 312719 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310837 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 310837 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 310837 0
Australia
Date submitted for ethics approval [1] 310837 0
28/03/2022
Approval date [1] 310837 0
12/05/2022
Ethics approval number [1] 310837 0

Summary
Brief summary
The primary objective is to study in vivo biofilm formation, growth, and undisturbed 3-dimensional architecture on different implant abutments restorative materials in an implant-supported biofilm device.

The secondary objective is to analyse and compare the microbiological composition of this biofilm grown on different implant abutments restorative materials.


Study Procedures
- An implant-supported biofilm device will be fabricated using CAD-CAM and will be designed in a way where a disk can be inserted inside a chamber. The chamber will also consist of a channel that is directed and opens into the sulcular and marginal (interproximal) region in order to allow gingival crevicular fluid, saliva, and substrate to flow into the chamber.
- Disks of five different restorative materials (titanium, zirconia, gold, dental ceramic, and polymeric material (Polymethylmethacrylate (PMMA) or Polyetheretherketone (PEEK)) will be fabricated and mounted in the chamber.
- Biofilm will be allowed to grow on each material for 14-days in a cross-over design where the first disk will be removed and then the following one will be inserted and so on. The order in which the five materials are inserted into the five participants will be randomised.
- Confocal laser microscopy will be used to analyse the architecture and viability of the biofilm grown on the disks. Next-generation sequencing will be performed to analyse and compare the bacterial composition of this chamber grown biofilm on the different implant abutments restorative materials
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119042 0
Dr Fady Bassily Wadie Bassily
Address 119042 0
Sydney Dental Hospital
2 Chalmers Street Surry Hills NSW 2010
Country 119042 0
Australia
Phone 119042 0
+61 416660313
Fax 119042 0
Email 119042 0
fbas0584@uni.sydney.edu.au
Contact person for public queries
Name 119043 0
Dr Fady Bassily Wadie Bassily
Address 119043 0
Sydney Dental Hospital
2 Chalmers Street Surry Hills NSW 2010
Country 119043 0
Australia
Phone 119043 0
+61 416660313
Fax 119043 0
Email 119043 0
fbas0584@uni.sydney.edu.au
Contact person for scientific queries
Name 119044 0
Dr Fady Bassily Wadie Bassily
Address 119044 0
Sydney Dental Hospital
2 Chalmers Street Surry Hills NSW 2010
Country 119044 0
Australia
Phone 119044 0
+61 416660313
Fax 119044 0
Email 119044 0
fbas0584@uni.sydney.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
Individual participant data will be stored on RedCap and only the primary investigator and head of department will have access to it.


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.