None listed
Conditions
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.
Interventions
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 periodontit
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.
Sponsors
The University of Sydney
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
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)
Outcome results
None listed