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:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT03631693
Eligibility Criteria:
Inclusion Criteria:
1. Systemically healthy males and females ≥ 30 years of age.
2. Participants must be willing to read, and sign a copy of the "Informed Consent Form" (ICF) form after reading the, "Patient Information Leaflet" (PIS), and after the nature of the study has been fully explained.
3. Participants must present with clinical and radiographic evidence of periodontitis, with one interdental area of Periodontal Pocket Depth (PPD) ≥6mm, Bleeding On Probing (BOP), and Clinical Attachment Level (CAL) ≥6mm in any posterior sextant of their mouth (excluding third molars and the distal aspect of the second molars), or multiple sites (≥9) with PPD ≥5mm, BOP, and CAL ≥5mm.
4. Participants must have completed a course of non-surgical periodontal therapy within 2 years prior to study commencement and have had maintenance including subgingival debridement within 6 months prior to assessment for eligibility.
Exclusion Criteria:
1. Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases e.g. cardiovascular disease or AIDS.
2. Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
3. History of alcohol or drug abuse.
4. Self-reported pregnancy or lactation.
5. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration that may interfere with the interpretation of the data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT03631693
Study Brief:
Protocol Section:
NCT03631693