ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

peri-implant biofilm

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

Biofilm thickness assessed by 3D reconstruction of intact subgingival biofilm using confocal scanning laser microscopy

Timepoint [1]

1-hour, 24-hours, 2-days, 4-days, 7-days, and 14-days after using the ISBC device

Secondary outcome [1]

Microbiological composition of subgingival oral biofilm using the novel implant-supported biofilm chamber device using next generation sequencing

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Sydney Dental Hospital - Surry Hills

Recruitment postcode(s) [1]

2010 - Surry Hills

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Sydney - Faculty of Medicine and Health

Address [1]

The University of Sydney, Science Rd, Camperdown NSW 2050

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

Research Ethics and Governance Office, Royal Prince Alfred Hospital, Camperdown NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

12/05/2021

Ethics approval number [1]

X21-0042

Summary

Brief summary

Dental plaque has been defined as a community of microorganisms found on oral structures are embedded in a matrix of polymers of host and bacterial origin (Marsh, 2006). The nature and complexity of oral biofilms have led to the development of various intra-oral devices and models to study the oral microbiome. In vitro biofilm models with conventional culture methods have contributed to significant advances in understanding the oral microbiota, however, the in vitro model cannot mimic the exact in vivo environment which leads to incomparable biofilm to the one found in situ (Robinson et al., 1997; Yu et al., 2017). Several techniques have been identified in the literature to harvest the dental plaque by using paper points, cotton rolls, and scalers (Abdullah et al., 2019; Prada-López et al., 2016). However, these methods mentioned above are impossible to collect all bacteria from in situ and doubtlessly disrupt the three-dimensional architecture of the biofilm (Wood et al., 1999). A rapidly developing technique for studying an undisturbed biofilm is using an intra-oral dental appliance as a biofilm collection device (Abdullah et al., 2019). However, the main shortcomings of these devices are that they are removed during mealtimes with the biofilm not being exposed to the patient’s diet, as well as no exposure to gingival crevicular fluid.

The aim of the project is to develop an implant-supported device that can grow a biofilm that has a similar composition to that collected subgingivally at a natural tooth.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Denny Luo

Address

Sydney Dental Hospital, Department of Periodontics, 2 Chalmers St, Surry Hills NSW 2010

Country

Australia

Phone

+61292933272

Fax

jluo9799@uni.sydney.edu.au

Contact person for public queries

Name

Denny Luo

Address

Sydney Dental Hospital, Department of Periodontics, 2 Chalmers St, Surry Hills NSW 2010

Country

Australia

Phone

+61292933333

Fax

jluo9799@uni.sydney.edu.au

Contact person for scientific queries

Name

Denny Luo

Address

Sydney Dental Hospital, Department of Periodontics, 2 Chalmers St, Surry Hills NSW 2010

Country

Australia

Phone

+61292933333

Fax

jluo9799@uni.sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
14573	Ethical approval					383348-(Uploaded-24-12-2021-10-31-57)-Study-related document.pdf
14574	Informed 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.

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