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Trial registered on ANZCTR


Registration number
ACTRN12622000203752
Ethics application status
Approved
Date submitted
17/01/2022
Date registered
7/02/2022
Date last updated
14/01/2024
Date data sharing statement initially provided
7/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Gum disease, its effect on the quality of life and development of a new tool for its diagnosis
Scientific title
The quality of life of patients with periodontal diseases and investigation of the lipid-A based biomarkers as potential diagnostic tool
Secondary ID [1] 306217 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontitis 324930 0
Condition category
Condition code
Oral and Gastrointestinal 322363 322363 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
Primary objective:

The primary objective of this project is to develop and evaluate a quick, efficient, and objective monitoring and diagnostic method, based on the subgingival and salivary Limulus Amoebocyte Lysate (LAL) assay, with the ability to screen for susceptibility to periodontal diseases, identify disease progression, evaluate response to treatment and predict future tissue destruction.

Secondary objective (Sydney cohort):

The study also aims to investigate the impact of periodontitis on oral health-related quality of life and contributing factors in the Sydney cohort of participants.

This project will include participants from collaboration with the following Universities:
University of Helsinki Finland and their “Corogene” study which contributing with saliva and dental plaque samples taken from 350 participants, Corogene Study - THL Biobank - THL
King’s College London will contribute with saliva and subgingival dental plaque samples from 80 participants,
University of Sydney, Australia will contribute with saliva and subgingival dental plaque samples from 90 participants.
The samples from the Finnish cohort will be used for biomarker derivation and assessing their clinical utility, while samples from Sydney and King’s College London will be used for external validation of the biomarkers.

The Sydney study will recruit 90 participants; 30 participants with healthy periodontium, 30 participants with plaque induced gingivitis and 30 with periodontitis.
Samples of saliva and subgingival dental plaque will be collected from all participants at baseline.
Participants with gingivitis and/or periodontitis will undergo standard treatment/therapy (details provided as attached document "Standard of care for patients with periodontitis") and samples will also be taken following the therapy. All patients will be required to complete questionnaires related to risk factors, quality of life and VAS (provided as attached documents) prior to commencement of therapy.
Depending on diagnosis, patients will have to attend 2-5 sessions.
Each session will not take more than 60 minutes. Sample collection will take up to 8-10min and questionnaires up to 7 min.
Treatment of patients will not be affected by the study protocol or by the results, and each patient will receive same standard of care as if they do not participate in the study.
Adherence to the study visits will be monitored by attendance records that will be recorded by the clinical system Titanium and recorded in the patients' clinical files.
Intervention code [1] 322630 0
Treatment: Other
Intervention code [2] 322681 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330145 0
Lipopolysaccharide (LPS) from subgingival plaque and saliva samples
Timepoint [1] 330145 0
Before and following treatment
Primary outcome [2] 330357 0
Pro-inflammatory potential of subgingival and salivary LPS extracts
Timepoint [2] 330357 0
Baseline and following treatment
Primary outcome [3] 330358 0
Endotoxin activity of subgingival and salivary LPS extract
Timepoint [3] 330358 0
Baseline and following treatment
Secondary outcome [1] 405049 0
Secondary outcome of the study refers on determination of quality of life in the patients with gum diseases and factors that contribute/influence the quality of life. Results of all questionnaires will be analysed together.

Method of assessment: Questionnaires (Oral-Dental Health-Related Quality of Life United-Kingdom OHRQoL, Questionnaire - contributing factors and VAS (100mm scale)
Timepoint [1] 405049 0
Baseline

Eligibility
Key inclusion criteria
1. Periodontally healthy patients (participants)
2. Periodontally diseased patients with plaque-induced gingivitis and patients with periodontitis stage II, III or IV
3. Gender: no restrictions
4. Age range: >18 years
5. Patients (participants) in good systemic health (ASA class 1 and 2)
6. Patients (participants) from all dietary backgrounds
7. Willingness to provide informed consent and willingness to participate and comply with the study requirements and protocol.
8. Patients who have not been treated from periodontal diseases in the previous 6 months and who are not currently receiving/undergoing periodontal therapy
9. Patients that are not currently involved in periodontal maintenance program
10. Women of childbearing potential who are using a reliable contraceptive method(s).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
2. Participants currently experiencing psychological illness or other conditions which may interfere with their ability to understand the study requirements or interfere with their motivation to participate in the study.
3. Participants with a history of active periodontal treatment (subgingival instrumentation) in the previous 6 months.
4. Participants who have taken antibiotics within the past 3 months.
5. Patients taking non-steroidal anti-inflammatory medications or those who were on these medications in the past 4 weeks
6. Patients who received any acute treatment or had acute diseases in previous 4 weeks
7. Participants with a history of any serious and uncontrolled systemic diseases (ASA class 3-6)
8. Participants on supportive periodontal therapy
9. Participants unable to obtain sufficient level of oral hygiene for successful treatment outcomes (approximal plaque index API (35%) (Lange, 1975) and Sulcus bleeding index SBI (25%) Muhlemann, 1971)

Study design
Purpose of the study
Diagnosis
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
Recruiting
Date of first participant enrolment
Anticipated
18/02/2022
Actual
15/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
70
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21494 0
Sydney Dental Hospital - Surry Hills
Recruitment hospital [2] 21495 0
Westmed Centre - Westmead
Recruitment postcode(s) [1] 36400 0
2010 - Surry Hills
Recruitment postcode(s) [2] 36401 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 310567 0
University
Name [1] 310567 0
The University of Sydney
Country [1] 310567 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Sydney Dental Hospital
2 Chalmers St
Surry Hills, 2010 NSW
Country
Australia
Secondary sponsor category [1] 311742 0
Hospital
Name [1] 311742 0
Sydney Dental Hospital
Address [1] 311742 0
2 Chalmers St
Surry Hills, 2010 NSW
Country [1] 311742 0
Australia
Secondary sponsor category [2] 311753 0
Hospital
Name [2] 311753 0
Westmead Centre for Oral Health (WCOH)
Address [2] 311753 0
Darcy Rd
Westmead, NSW 2145
Country [2] 311753 0
Australia
Secondary sponsor category [3] 311754 0
Hospital
Name [3] 311754 0
King's College London
Address [3] 311754 0
Guy’s Hospital, 18th Floor
Great Maze Pond, London SE1 9RT
Country [3] 311754 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310174 0
Sydney Local Health District Human Research Ethics Committee Concord Repatriation General Hospital
Ethics committee address [1] 310174 0
Sydney Local Health District Human Research Ethics Committee
Concord Repatriation General Hospital
Concord NSW 2139
Ethics committee country [1] 310174 0
Australia
Date submitted for ethics approval [1] 310174 0
Approval date [1] 310174 0
09/11/2021
Ethics approval number [1] 310174 0

Summary
Brief summary

This study has two main goals:

1. Identifying parts of bacteria that live in your mouth. Identification of these special parts will help us to create tests that may be used in early detection of gum disease. The tests may also enable better and more successful treatment of gum disease. To look for bacteria, samples of your saliva (2-5ml) and dental plaque will be collected before and after treatment. Depending on the initial health of your gums and diagnosis, you will be asked to attend between 2 and 6 visits.

2. Determining how gum disease affects quality of life. To explore this, you will be asked to complete three questionnaires during your first visit.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116750 0
Dr Tihana Divnic-Resnik
Address 116750 0
Sydney Dental Hospital
2 Chalmers St.
Surry Hills, NSW 2010
Country 116750 0
Australia
Phone 116750 0
+61449855962
Fax 116750 0
Email 116750 0
tihana.divnic-resnik@sydney.edu.au
Contact person for public queries
Name 116751 0
Dr Tihana Divnic-Resnik
Address 116751 0
Sydney Dental Hospital
2 Chalmers St.
Surry Hills, NSW 2010
Country 116751 0
Australia
Phone 116751 0
+61449855962
Fax 116751 0
Email 116751 0
tihana.divnic-resnik@sydney.edu.au
Contact person for scientific queries
Name 116752 0
Dr Tihana Divnic-Resnik
Address 116752 0
Sydney Dental Hospital
2 Chalmers St.
Surry Hills, NSW 2010
Country 116752 0
Australia
Phone 116752 0
+61449855962
Fax 116752 0
Email 116752 0
tihana.divnic-resnik@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
Patient information are highly confidential.
Only de-identified data necessary for statistical analyses will be shared with collaborators from the KCL.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14679Ethical approval    383423-(Uploaded-17-01-2022-14-56-43)-Study-related document.pdf
14680Study protocol    Study protocol includes statistical analysis plan 383423-(Uploaded-17-01-2022-15-19-26)-Study-related document.docx
14681Informed consent form    Informed consent form 383423-(Uploaded-17-01-2022-15-28-08)-Study-related document.doc
14683Other    Information for participants (PIS) 383423-(Uploaded-17-01-2022-15-29-00)-Study-related document.doc
14684Other    Questionnaire quality of life 383423-(Uploaded-17-01-2022-15-30-37)-Study-related document.docx
14685Other    Questionnaire risk factors 383423-(Uploaded-17-01-2022-15-31-16)-Study-related document.docx
14686Other    Questionnaire - VAS scale 383423-(Uploaded-17-01-2022-15-32-01)-Study-related document.docx
14687Other    Material Transfer agreement between Syd Uni and KC... [More Details] 383423-(Uploaded-17-01-2022-15-33-20)-Study-related document.pdf
14688Other    Standard of care for patients with gum diseases 383423-(Uploaded-17-01-2022-15-34-38)-Study-related document.docx
14689Other    Sample collection protocol 383423-(Uploaded-17-01-2022-15-50-57)-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.