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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT05275192
Eligibility Criteria:
Inclusion Criteria:
* • Individual must be between the age of 18 and 70 years of age
* ASA I or II systemically healthy subjects
* Individuals presenting with at least 1 single or multirooted tooth with residual, isolated, interproximal bony defect with probing depths (PD) ≥ 6 mm, clinical attachment loss (CAL) ≥ 6mm, bleeding upon probing (BOP), and ≥ 2mm width of attached gingiva (WAG)
* Radiographic evidence of interproximal alveolar bone loss, on existing (\< 2 years old) dental radiographs of diagnostic quality taken at the COD
* Vital tooth or previous root canal therapy with no signs/symptoms of pathology
* Individuals with plaque scores ≤ 20%
* English speaking subjects (Individual must be willing to follow all the study requirements and participate in the study procedures in its entirety and read, understand the informed consent form)
Exclusion Criteria:
* Individuals not referred from the Predoctoral Periodontics Student Clinics
* Uncontrolled systemic disorders such as hypertension, heart disease, bleeding disorders, metabolic bone diseases, autoimmune disorders, etc., that may influence cellular/healing status
* Diabetics
* Current smokers
* Individual less than 18 years of age
* Individuals with non-isolated, interproximal PD ≥ 4 mm extending to the facial/buccal and/or palatal/lingual tooth surfaces
* Teeth with Grade 2 or 3 mobility
* Teeth with metal restorations such as a porcelain fused to metal crown (due to scattering of radiographic images)
* Intrabony defects on dental implants
* Individual who take medications known to affect host immunity or periodontal tissues (ex. steroids, antibiotics, phenytoin, etc.) in the previous 6 months
* Individuals on chronic anti-platelet/anti-coagulant therapy
* Oral pathologies other than periodontal disease (ex. periapical lesions of non-periodontal origin)
* Subjects who may be pregnant based on a positive pregnancy test
* Non-English speaking individuals
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05275192
Study Brief:
Protocol Section:
NCT05275192