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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT06409468
Eligibility Criteria:
Inclusion Criteria:
* Male or female, between 20-70 years of age, who request gingival augmentation or recession coverage.
* Subjects who are willing to sign an informed consent, participate and return for follow-up visits.
* Subjects without significant medical history and currently not on medications that might complicate treatment outcomes.
* Subjects demonstrating good oral hygiene (FMPS, FMBS less than 20%).
Exclusion Criteria:
* Subjects who do not meet all the inclusion criteria or who will not cooperate with the protocol schedule.
* Subjects who received and failed a previously placed autogenous graft.
* Subjects who have significant untreated periodontal disease, caries, infection or chronic inflammation in the oral cavity within two adjacent tooth positions of the clinical trial area.
* Subjects who have used nicotine-containing products within 3 weeks prior to surgery.
* Subjects who are insulin-dependent diabetic or if their Hgb1c levels \> 6.5%.
* Subjects who have had a history of malignancy within the past 5 years (except for basal or squamous cell carcinoma of the skin or in situ cervical carcinoma).
* Subjects who are nursing or pregnant.
* Subjects who are presently taking medications (except estrogen/progesterone therapy) or those who are undergoing treatment that in known to have an effect on bone turnover.
* Subjects who have diseases that affect bone metabolism (excluding idiopathic osteoporosis).
* Subjects with a history of an autoimmune disease, documented allergy or multiple allergies to any component of the agents used in this study.
* Acutely infected mucogingival defect site.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT06409468
Study Brief:
Protocol Section:
NCT06409468