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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT02987634
Eligibility Criteria:
Inclusion Criteria:
1. Subjects must be adult males or females over the age of 18 years.
2. Subjects must be able and willing to follow study procedures and instructions.
3. Subjects must present with the need for implant surgery that would necessitate surgical incision (flap elevation) and transgingival implant healing cap, be available for follow-up visits and be able to follow rinse protocol instructions.
Exclusion Criteria:
1. Subjects who exhibit gross oral pathology and severe gingival inflammation at the time of surgery at the projected surgical site.
2. Subjects chronically treated (i.e., ≥ two weeks) with anti-inflammatory medications (steroids or nonsteroidal anti-inflammatory drugs) or any other medications known to affect gingival tissue status (e.g., phenytoin, cyclosporine) within one month of the screening examination. Prophylactic use of aspirin ( 81 mg daily) and Plavix when used for cardiovascular indications will be permitted (a note should be inserted into patient's documentation) and any therapeutic treatment modifications will be under the jurisdiction of the treating dentist. All other medications for chronic medical conditions should be initiated at least three months prior to enrollment.
3. Subjects with active infectious diseases such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
4. Subjects with Types I or II diabetes, thyroid disease or cancer chemotherapy
5. Subjects reporting allergies to the constituents in the rinse
6. Female subjects who report being pregnant or lactating
7. Subjects with clinically significant laboratory results
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02987634
Study Brief:
Protocol Section:
NCT02987634