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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT01180920
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for diseased subjects:
* Diagnosis of generalized chronic or aggressive periodontitis
* At least four periodontal sites with probing depth (PD) ≥6 mm, evidence of clinical attachment loss (CAL), and bleeding on probing (BOP). Inclusion criteria for healthy individuals will include PD \<4 mm, no evidence of attachment loss, and \<10% of sites with BOP
* Need an open flap procedure
Inclusion criteria for non-diseased subjects:
* Subjects requiring a gingivectomy or crown lengthening procedure
Exclusion Criteria:
* History of alcoholism or drug abuse
* Medical conditions that may affect the outcome such as autoimmune diseases, diabetes, immunocompromised subjects, neurologic or psychiatric disorders, systemic infections, etc.
* Chronic medications known to affect the periodontal status (calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications, Depo-Provera contraceptive injection users, new oral contraceptives users within 3 months of baseline or subjects that are planning on, starting oral contraceptives during the study.
* Antibiotic therapy within 3 months of the baseline visit, and/or antibiotic therapy needed for infective endocarditis prophylaxis.
* Current use or quit smoking less than one year ago with a pack-year history of more than or equal to 10.
* Untreated cavities
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01180920
Study Brief:
Protocol Section:
NCT01180920