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 @ 6:25 PM
Ignite Modification Date:
2025-12-24 @ 6:25 PM
NCT ID:
NCT05684068
Eligibility Criteria:
Inclusion Criteria:
* Patients 18-95 years of age
* Inactive periodontal disease
* Lack of, or an insufficient (less than 2 millimeters) band of keratinized tissue width on the buccal site (closest to the cheek)
* Shallow vestibule depth (the space between the soft tissue (lips and cheeks), and the teeth and gums)
* Thin gingival phenotype (less than 1.5mm of gum tissue depth).
* Aberrant frenum attachment in need of free-epithelized gingival grafts.
* At least one RT1, 2, or 3 (Cairo's classification) gingival recession defect on the mandibular anterior sextant (Teeth #22-27).
* Non-smokers or past smokers (those who have stopped at minimum 6 months ago).
* Patient willing and able to follow instruction related to the study procedures.
Exclusion Criteria:
* Previous soft tissue augmentation procedures at the area of interest.
* Current smokers (Light smokers meaning less than 10 cigarettes/day, heavy smokers meaning more than 10 cigarettes/day, or social smokers)
* Uncontrolled systemic disease (uncontrolled diabetes defined by blood sugar HbA1c greater than 7%)
* Any active local or systemic infections
* Any diseases or medications that may compromise normal wound healing
* Currently receiving chemotherapy or radiotherapy or a history of radiotherapy in head and neck area.
* Severe hematologic (blood) disorders
* Pregnancy or nursing mother
* Patients undergoing orthodontic therapy
* Patients taking antibiotics in the past 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT05684068
Study Brief:
Protocol Section:
NCT05684068