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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT04830969
Eligibility Criteria:
Inclusion Criteria:
1. Be able to understand the informed consent form and be willing and able to read and sign it.
2. At least 25 years of age.
3. Be able to understand and follow directions for study procedures.
4. At least 14 natural teeth, not counting third molars ("wisdom teeth").
5. At least 2 interproximal sites with CAL \>= 4 mm or at least 2 interproximal sites with PD \>= 5 mm.
Exclusion Criteria:
1. Presence of orthodontic appliances ("braces").
2. An abnormal condition of lips, lining of the mouth, tongue, or gums (except for periodontal disease). If subject has a cold sore, canker sore, or injury in their mouth, they may return after the sore or injury heals.
3. Abscess of the gingiva caused by periodontal disease, or visible gross tooth decay
4. A broken tooth root or an abscessed tooth. Subject may be allowed to participate in the study after the condition is successfully treated.
5. Periodontal treatment or antibiotic therapy in the past 6 months.
6. Have used cigarettes or other tobacco products in the past year.
7. Body mass index (BMI) is \> 40.
8. Have regularly used non-steroidal anti-inflammatory drugs (such as \>= 325 mg aspirin or ibuprofen) over the past 3 weeks.
9. Regularly using drugs that weaken the immune system (such as corticosteroids taken by mouth or injection, and cyclosporine).
10. Have participated in another clinical research study in the past 30 days.
11. Pregnant or breastfeeding.
12. Have a condition that we feel will make study participation unsafe or difficult for the patient.
13. Require premedication for dental exams.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT04830969
Study Brief:
Protocol Section:
NCT04830969