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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT05947305
Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologists (ASA) Physical Status Classification I or II
* Subjects undergoing periodontal surgical procedures that involve harvesting of soft tissue samples, who have a treatment plan including the use or removal of keratinized mucosa or subepithelial connective tissue that will not require additional anesthesia for sample collection
* Adequate physical and mental health to undergo routine dental treatment
* Ability and willingness to follow instructions related to the study procedures
Exclusion Criteria:
* Poorly controlled diabetes, defined as HbA1c \>/= 7.0
* Autoimmune or inflammatory conditions such as systemic lupus erythematous, rheumatoid arthritis.
* Pregnant women or nursing mothers, or unsure of pregnancy status (self-reported)
* Severe hematologic disorders, such as leukemia or hemophilia
* Subjects on anticoagulant or antiplatelet therapy
* Local or systemic infection that may interfere with healing
* Hepatic or renal diseases
* Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy
* History of antibiotic or immunosuppressant use in the last 3 months
* Subjects on concomitant drug therapy for systemic conditions that may affect outcomes of the study
* Current smokers (CDC definition): heavy smokers: subjects who have smoked \>10 cigarettes per day within 6 months of study onset, and have smoked \>100 cigarettes in their lifetime
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05947305
Study Brief:
Protocol Section:
NCT05947305