Gum disease, its effect on the quality of life and development of a new tool for its diagnosis

Not Applicable

Recruiting

• Conditions: Periodontitis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622000203752
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-07
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ipopolysaccharide (LPS) from subgingival plaque and saliva samples<br>[ Before and following treatment];Pro-inflammatory potential of subgingival and salivary LPS extracts[ Baseline and following treatment];Endotoxin activity of subgingival and salivary LPS extract[ Baseline and following treatment]

Secondary Outcome Measures

Name	Time	Method
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.<br><br>Method of assessment: Questionnaires (Oral-Dental Health-Related Quality of Life United-Kingdom OHRQoL, Questionnaire - contributing factors and VAS (100mm scale)<br> [ Baseline]