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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT01399034
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be adult males or females between the ages of 18 and 65 years (inclusive).
* Subjects must be able and willing to follow study procedures and instructions.
* Subjects must have read, understood and signed an informed consent form.
* Subjects must present with at least 20 teeth in the functional dentition, excluding third molars.
* Subjects must be in good general health.
* Subjects must present with advanced chronic periodontitis (American Dental Association Class 4) as determined by the investigator or designee during the screening periodontal examination. Such subjects will exhibit periodontal pocketing (\>5 mm and Bleeding on Probing) and severe alveolar bone loss. Subjects will be under active care for periodontitis and will be treatment planned for periodontal flap surgery.
* Control subjects must present with periodontal health as determined by the investigator or designee during the screening periodontal examination. Such subjects will exhibit no evidence of periodontal pocketing (pockets ≤4mm), and no bleeding on probing at the site of the biopsy. Patients from this group will be treatment planned for routine crown extension procedures for restorative reasons, or be volunteers from the general population meeting the inclusion criteria.
* 24 subjects from group 2 will be enrolled based on Body Mass Index (BMI). Twelve obese subjects (BMI of 30 or greater) and twelve non-obese subjects (BMI less than 30) will be enrolled. Twelve from the obese and twelve from the non-obese group will be split in half based on periodontal status.
* 6 periodontal healthy non-obese
* 6 periodontal healthy obese
* 6 periodontal diseased non-obese
* 6 periodontal diseased obese
Exclusion Criteria:
* Individuals who have a chronic disease with oral manifestations.
* Individuals who exhibit gross oral pathology.
* Treatment with antibiotics for any medical or dental condition within 1 month prior to the screening examination.
* Chronic treatment (i.e., two weeks or more) with any medication known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, coumadin, non-steroidal anti-inflammatory drugs, aspirin) within one month of the screening examination.
* Ongoing medications initiated less than three months prior to enrollment (i.e., medications for chronic medical conditions must be initiated at least three months prior to enrollment).
* Subjects with clinically significant organ disease including impaired renal function, or any bleeding disorder.
* Subjects with active infectious diseases such as hepatitis, HIV or tuberculosis.
* Severe unrestored caries, or any condition that is likely to require antibiotic treatment over the trial, including the need for prophylactic antibiotic
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01399034
Study Brief:
Protocol Section:
NCT01399034