Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000087752
Ethics application status
Approved
Date submitted
24/12/2021
Date registered
24/01/2022
Date last updated
24/01/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A new oral bacteria model using a dental implant-supported device
Scientific title
A depiction of the architecture and composition of subgingival oral biofilm using a novel implant-supported biofilm chamber in-situ
Secondary ID [1] 306110 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
peri-implant biofilm 324784 0
Condition category
Condition code
Oral and Gastrointestinal 322234 322234 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 aim of the project is to develop an implant-supported device (ISBC) that can grow a biofilm that has a similar composition to that collected subgingivally at a natural tooth. The ISBC will be designed and fabricated using CAD-CAM and will be constructed in a way where a disk can be mounted/inserted into a chamber and easily covered with composite resin. Biofilm will be allowed to grow, and the disk will be removed for microbiological analysis (biofilm thickness and composition) at 1-hour, 24-hours, 2-days, 4-days, 7-days, and 14-days. A total of 12 disks will be fabricated per participant (2 disks for each timepoint).

The ISBC device will be attached to an implant that has been placed at the Sydney Dental Hospital - Department of Periodontics. The device will also act as a temporary crown (cap) prior to placing the final implant-supported crown. The temporary crown is secured to
the implant with a screw. The sample collection will occur at 1-hour, 24-hours, 2-days, 4-days, 7-days, and 14-days interval after the placement of the device. Furthermore, the bacteria sample from around a natural tooth on the opposite side of the mouth will be collected at each time point for comparison. The sample will be collected by Dr. Denny Luo (investigator of this research). A total of 6-visits is required where the total appointment time for each of these visits will not exceed 45-minutes.
All the information collected for the study will be treated confidentially and will be
stored on a secure research database (REDCap). Only the researchers named in this study
will have access to it. A Data Safety Monitoring Board will oversee this study to review, at regular intervals, accumulating trial data, in order to monitor the progress of this study. The DSMB will meet after the first 3 participants and then once a month until completion of the study.
Intervention code [1] 322527 0
Treatment: Devices
Comparator / control treatment
The comparator / control treatment is the natural biofilm found and collected from an adjacent tooth from the contralateral side of the mouth. Biofilm grown on the disk will be scraped off using a sterile instrument (curette) and transferred into an Eppendorf tube containing PBS. Similarly, biofilm collected from an adjacent tooth from the contralateral side of the mouth will be transferred into an Eppendorf tube containing PBS.
Control group
Active

Outcomes
Primary outcome [1] 330009 0
Biofilm thickness assessed by 3D reconstruction of intact subgingival biofilm using confocal scanning laser microscopy
Timepoint [1] 330009 0
1-hour, 24-hours, 2-days, 4-days, 7-days, and 14-days after using the ISBC device
Secondary outcome [1] 404579 0
Microbiological composition of subgingival oral biofilm using the novel implant-supported biofilm chamber device using next generation sequencing
Timepoint [1] 404579 0
1-hour, 24-hours, 2-days, 4-days, 7-days, and 14-days after using the ISBC device

Eligibility
Key inclusion criteria
• Adults aged 25 and with dental implants present.
• Medically healthy participants with no active systemic disease or medication associated with implant failure.
• No active caries, periodontal or peri-implant disease
• Participants need to be willing to provide informed consent and willing to participate and comply with the study requirements.
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Participants with active systemic disease or medication associated with implant failure. Absolute contraindications 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.
• Systemic Antibiotics within the last 3 months
• Women that are pregnant or lactating.
• The ISBC will be removed if any clinical signs of irritation or signs of an active peri-implant disease are present which would require immediate treatment.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical analysis of the quality-filtered and classifier sequence data will be undertaken in R (version 3.5.1). Statistical analysis will include calculation of alpha and beta diversity metrics. These in addition to abundance data of individual species will be used to assess the variation in species composition between the implant and curette collection method.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
2/05/2022
Actual
Date of last data collection
Anticipated
29/07/2022
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21421 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 36320 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 310464 0
University
Name [1] 310464 0
University of Sydney - Faculty of Medicine and Health
Country [1] 310464 0
Australia
Primary sponsor type
University
Name
University of Sydney - Faculty of Medicine and Health
Address
The University of Sydney, Science Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 311614 0
None
Name [1] 311614 0
Address [1] 311614 0
Country [1] 311614 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310095 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 310095 0
Ethics committee country [1] 310095 0
Australia
Date submitted for ethics approval [1] 310095 0
Approval date [1] 310095 0
12/05/2021
Ethics approval number [1] 310095 0
X21-0042

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

Contacts
Principal investigator
Name 116450 0
Dr Denny Luo
Address 116450 0
Sydney Dental Hospital, Department of Periodontics, 2 Chalmers St, Surry Hills NSW 2010
Country 116450 0
Australia
Phone 116450 0
+61292933272
Fax 116450 0
Email 116450 0
[email protected]
Contact person for public queries
Name 116451 0
Denny Luo
Address 116451 0
Sydney Dental Hospital, Department of Periodontics, 2 Chalmers St, Surry Hills NSW 2010
Country 116451 0
Australia
Phone 116451 0
+61292933333
Fax 116451 0
Email 116451 0
[email protected]
Contact person for scientific queries
Name 116452 0
Denny Luo
Address 116452 0
Sydney Dental Hospital, Department of Periodontics, 2 Chalmers St, Surry Hills NSW 2010
Country 116452 0
Australia
Phone 116452 0
+61292933333
Fax 116452 0
Email 116452 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This research study is presented as a project that is part of the research component of Doctor of Clinical Dentistry (Periodontics) at the University of Sydney. HREC have given ethics approval provided that the data will be presented as an aggregate where the final manuscript may be published in peer-reviewed research journals and a basic overview of the research study may be presented at relevant research conferences.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14573Ethical approval    383348-(Uploaded-24-12-2021-10-31-57)-Study-related document.pdf
14574Informed consent form    383348-(Uploaded-24-12-2021-10-33-32)-Study-related document.pdf



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.