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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
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Scientific title
The quality of life of patients with periodontal diseases and investigation of the lipid-A based biomarkers as potential diagnostic tool
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Secondary ID [1]
306217
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Periodontitis
324930
0
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Condition category
Condition code
Oral and Gastrointestinal
322363
322363
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
322630
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Treatment: Other
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Intervention code [2]
322681
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
330145
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Lipopolysaccharide (LPS) from subgingival plaque and saliva samples
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Assessment method [1]
330145
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Timepoint [1]
330145
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Before and following treatment
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Primary outcome [2]
330357
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Pro-inflammatory potential of subgingival and salivary LPS extracts
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Assessment method [2]
330357
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Timepoint [2]
330357
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Baseline and following treatment
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Primary outcome [3]
330358
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Endotoxin activity of subgingival and salivary LPS extract
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Assessment method [3]
330358
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Timepoint [3]
330358
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Baseline and following treatment
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Secondary outcome [1]
405049
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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)
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Assessment method [1]
405049
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Timepoint [1]
405049
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Baseline
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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).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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)
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
18/02/2022
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Actual
15/08/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
90
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Accrual to date
70
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
21494
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Sydney Dental Hospital - Surry Hills
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Recruitment hospital [2]
21495
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Westmed Centre - Westmead
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Recruitment postcode(s) [1]
36400
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2010 - Surry Hills
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Recruitment postcode(s) [2]
36401
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2145 - Westmead
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Funding & Sponsors
Funding source category [1]
310567
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University
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Name [1]
310567
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The University of Sydney
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Address [1]
310567
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Sydney Dental Hospital
2 Chalmers St
Surry Hills, 2010 NSW
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Country [1]
310567
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
Sydney Dental Hospital
2 Chalmers St
Surry Hills, 2010 NSW
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Country
Australia
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Secondary sponsor category [1]
311742
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Hospital
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Name [1]
311742
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Sydney Dental Hospital
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Address [1]
311742
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2 Chalmers St
Surry Hills, 2010 NSW
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Country [1]
311742
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Australia
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Secondary sponsor category [2]
311753
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Hospital
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Name [2]
311753
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Westmead Centre for Oral Health (WCOH)
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Address [2]
311753
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Darcy Rd
Westmead, NSW 2145
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Country [2]
311753
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Australia
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Secondary sponsor category [3]
311754
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Hospital
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Name [3]
311754
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King's College London
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Address [3]
311754
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Guy’s Hospital, 18th Floor
Great Maze Pond, London SE1 9RT
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Country [3]
311754
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United Kingdom
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310174
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Sydney Local Health District Human Research Ethics Committee Concord Repatriation General Hospital
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Ethics committee address [1]
310174
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Sydney Local Health District Human Research Ethics Committee
Concord Repatriation General Hospital
Concord NSW 2139
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Ethics committee country [1]
310174
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Australia
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Date submitted for ethics approval [1]
310174
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Approval date [1]
310174
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09/11/2021
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Ethics approval number [1]
310174
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
116750
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Dr Tihana Divnic-Resnik
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Address
116750
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Sydney Dental Hospital
2 Chalmers St.
Surry Hills, NSW 2010
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Country
116750
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Australia
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Phone
116750
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+61449855962
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Fax
116750
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Email
116750
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[email protected]
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Contact person for public queries
Name
116751
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Dr Tihana Divnic-Resnik
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Address
116751
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Sydney Dental Hospital
2 Chalmers St.
Surry Hills, NSW 2010
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Country
116751
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Australia
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Phone
116751
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+61449855962
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Fax
116751
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Email
116751
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[email protected]
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Contact person for scientific queries
Name
116752
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Dr Tihana Divnic-Resnik
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Address
116752
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Sydney Dental Hospital
2 Chalmers St.
Surry Hills, NSW 2010
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Country
116752
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Australia
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Phone
116752
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+61449855962
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Fax
116752
0
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Email
116752
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
14679
Ethical approval
383423-(Uploaded-17-01-2022-14-56-43)-Study-related document.pdf
14680
Study protocol
Study protocol includes statistical analysis plan
383423-(Uploaded-17-01-2022-15-19-26)-Study-related document.docx
14681
Informed consent form
Informed consent form
383423-(Uploaded-17-01-2022-15-28-08)-Study-related document.doc
14683
Other
Information for participants (PIS)
383423-(Uploaded-17-01-2022-15-29-00)-Study-related document.doc
14684
Other
Questionnaire quality of life
383423-(Uploaded-17-01-2022-15-30-37)-Study-related document.docx
14685
Other
Questionnaire risk factors
383423-(Uploaded-17-01-2022-15-31-16)-Study-related document.docx
14686
Other
Questionnaire - VAS scale
383423-(Uploaded-17-01-2022-15-32-01)-Study-related document.docx
14687
Other
Material Transfer agreement between Syd Uni and KC...
[
More Details
]
383423-(Uploaded-17-01-2022-15-33-20)-Study-related document.pdf
14688
Other
Standard of care for patients with gum diseases
383423-(Uploaded-17-01-2022-15-34-38)-Study-related document.docx
14689
Other
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.
Download to PDF