Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT03358251
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Male or female, aged 18 and above
3. Provision of up-to-date full mouth periapical x-rays
4. Participants suffering from active moderate to severe chronic periodontitis with at least 3 sites of periodontal pockets of 5 mm or greater depth in each quadrant.
5. Participants with a minimum of 6 teeth with periodontal pocket depth of more than 5 mm.
6. Participants with a minimum of 20 teeth
Exclusion Criteria:
1. Known hypersensitivity to any of the devices components as listed on the user leaflet
2. Pregnancy or lactation
3. Smoking of more than 9 cigarettes per day
4. A concurrent dental disease, except for periodontitis, or planned treatment that may interfere with the study or study intervention, such as dental surgery, teeth implantation, etc.
5. Chronic disease such as diabetes mellitus or rheumatoid arthritis
6. Aggressive periodontitis
7. History of radiotherapy or chemotherapy
8. Immunodeficiency or autoimmune disease
9. Mental disorders
10. Parafunctional habits such as bruxism
11. Participant has taken antibiotics in the 6 months prior to the study
12. Participant has undergone periodontal treatment 12 months prior to the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03358251
Study Brief:
Protocol Section:
NCT03358251