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Trial registered on ANZCTR


Registration number
ACTRN12622000687796p
Ethics application status
Submitted, not yet approved
Date submitted
27/04/2022
Date registered
12/05/2022
Date last updated
13/04/2023
Date data sharing statement initially provided
12/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Analysis of undisturbed plaque formation, composition, and growth around dental implants
Scientific title
In vivo analysis of undisturbed peri-implant biofilm formation, composition, and growth in periodontally healthy and stable periodontitis patients
Secondary ID [1] 307014 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
peri-implant diseases 326139 0
Condition category
Condition code
Oral and Gastrointestinal 323457 323457 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
Potential participants will be identified and screened by the treating specialist periodontists (Axel Spahr and Jessica O’Neill) through routine assessment of hospital patients that have been referred for implant treatment. These patients will be screened for suitability for implant treatment, as well as eligibility for this research study. Patients that fulfil the inclusion criteria will be invited to participate in the research. A personal (face-to-face) invitation with a periodontics registrar (Judd Sher) will then be offered to interested patients where full-details and information about the study will be disclosed, as well as answering of any questions posed by the participants.

Straumann bone-level implants will be placed in a 90 minute appointment as per the manufacturers instructions by a registered periodontist (Axel Spahr and Jessica O’Neill) or periodontics registrar (Judd Sher) and allowed to osseointegrate for 12-weeks. An impression will be taken for study casts once soft-tissue healing following second-stage surgery is completed, where an Implant Supported Biofilm Chamber (ISBC) and custom abutment will be fabricated. The ISBC will be fabricated using CAD-CAM and will be designed in a way where discs can be inserted into a chamber which is easily coverable with composite resin.

The ISBC will be 3D-printed with a Formlabs Form 2/3B 3D-printer using a biocompatible light-cured dental resin (Dental LT Clear Resin, Formlabs) that is TGA- approved for dental applications such as occlusal splints, permanent and temporary restorations, and orthodontic appliances. Technical and safety data can be found on the manufacturer’s website: https://dental.formlabs.com/

The chamber will also consist of a channel that is directed and opens into the sulcular (interproximal) region, with to aim to allow gingival crevicular fluid (GCF), saliva and substrate to flow into the chamber. A zirconia disc with a standardised roughness will be milled and mounted in the ISBC. All ISBCs and discs will be disinfected in a 3% sodium hypochlorite solution for 10-minutes, rinsed in distilled water, and autoclaved before use. A final implant-supported prosthesis or restoration will be fabricated and inserted following completion of data collection.

The patient will receive a full mouth clean (mechanical removal of plaque and calculus) with ultrasonic and airflow prior to start of each time point. Oral hygiene instructions (OHI) will also be given to the patient: toothbrushing technique and interdental care. Two discs will be inserted into the ISBC at each time point. Biofilm will be allowed to grow, and the ceramic disk will be removed atraumatically for microbiological analysis and replaced with a new disc at 1-hour, 24-hours, 2-days, 4-days, 7-days, and 14-days. Each disk insertion/removal visit will take 30 minutes. A total of 12 discs will be fabricated per participant (2 disks will be inserted into the ISBC for each timepoint). At each time point following disc removal, one disk will be used to analyse biofilm viability with confocal laser scanning microscopy (CLSM) while the other will be used to analyse bacterial composition with next generation sequencing.
Intervention code [1] 323464 0
Treatment: Devices
Comparator / control treatment
No control. The device will be used in in stable periodontitis patients versus healthy patients, to analyse differences in the biofilm in these patients.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331201 0
The primary objective is to compare the formation, composition, and growth of an undisturbed sulcular biofilm grown in a novel ISBC in (i) periodontally healthy and (ii) stable periodontitis patients.

The formation, composition, and growth will be analysed together as a composite outcome.
Timepoint [1] 331201 0
Biofilm will be allowed to grow on the discs for 1-hour, 24-hours, 2-days, 4-days, 7-days, and 14-days before being removed for microbiological analysis.
Secondary outcome [1] 409151 0
None.
Timepoint [1] 409151 0
nil

Eligibility
Key inclusion criteria
• Adult patients ( greater than or equal to 21 yoa) that are suitable for treatment with single-tooth dental implants, or have received a dental implant that requires a restoration, in the posterior region (non-aesthetic sites)
• Periodontally healthy with no history of periodontitis or Stable Stage 2/3 Grade A/B periodontitis according to the 2017 world workshop on the classification of periodontal and peri-implant diseases and conditions (Chapple et al., 2018; Tonetti, Greenwell, & Kornman, 2018)
• Good oral hygiene assessed by full-mouth bleeding and plaque score
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Patients with an absolute contraindication to dental implant treatment including recent myocardial infarction and cerebrovascular accident, valvular prosthesis surgery, immunosuppression, bleeding issues, active treatment of malignancy, drug abuse, psychiatric illness, and intravenous bisphosphonate use
• Participants with failing/compromised implants or peri-implantitis
• Implant sites located in aesthetic zones, and sites that require tissue augmentation / grafting
• Pregnant/lactating patients
• Patients who have received antibiotics within the past 3 months
• Edentulous patients

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311324 0
University
Name [1] 311324 0
University of Sydney
Country [1] 311324 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
2 Chalmers St, Surry Hills NSW 2010
Country
Australia
Secondary sponsor category [1] 312701 0
None
Name [1] 312701 0
Address [1] 312701 0
Country [1] 312701 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310825 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 310825 0
50 Missenden Rd, Camperdown NSW 2050
Ethics committee country [1] 310825 0
Australia
Date submitted for ethics approval [1] 310825 0
27/04/2022
Approval date [1] 310825 0
Ethics approval number [1] 310825 0

Summary
Brief summary
This will be the first study to analyse the formation, composition, and growth of an undisturbed peri-implant sulcular biofilm using a novel ISBC device developed by the University of Sydney. The study hypothesis is that the ISBC will allow us to analyse and compare the formation, composition, and growth of an undisturbed peri-implant sulcular biofilm in (i) periodontally healthy and (ii) stable periodontitis patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118998 0
Dr Judd Sher
Address 118998 0
Sydney Dental Hospital
2 Chalmers St, Surry Hills NSW 2010
Country 118998 0
Australia
Phone 118998 0
+61 458931203
Fax 118998 0
Email 118998 0
[email protected]
Contact person for public queries
Name 118999 0
Judd Sher
Address 118999 0
Sydney Dental Hospital
2 Chalmers St, Surry Hills NSW 2010
Country 118999 0
Australia
Phone 118999 0
+61 458931203
Fax 118999 0
Email 118999 0
[email protected]
Contact person for scientific queries
Name 119000 0
Judd Sher
Address 119000 0
Sydney Dental Hospital
2 Chalmers St, Surry Hills NSW 2010
Country 119000 0
Australia
Phone 119000 0
+61 458931203
Fax 119000 0
Email 119000 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
REDCap will be used to store data collected and will only be accessed by Judd Sher.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15883Study protocol    383985-(Uploaded-09-05-2022-18-15-48)-Study-related document.docx
15884Informed consent form    383985-(Uploaded-03-05-2022-19-22-47)-Study-related document.docx



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.