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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07440303
Eligibility Criteria:
Inclusion Criteria:
* Adults 20 - 80 years old who need gingival augmentation on both sides of the lower jaw.
* Able and willing to sign the consent form, follow study instructions and return for all visits
* Generally healthy (no significant illnesses or medicines that could interfere with healing).
* Demonstrates good daily oral hygiene (low plaque levels at baseline).
Exclusion Criteria:
* Does not meet any of the inclusion points or is unlikely to follow the schedule
* Previous gingival graft at the study site that failed
* Needs a root-coverage (recession-repair) procedure instead of simple width augmentation
* Active, untreated gum disease, cavities, infection, or chronic inflammation near the study teeth
* Used cigarettes, e-cigarettes, or other nicotine products within 3 weeks
* Insulin-dependent diabetes or hemoglobin A1c \> 6.5 %
* Cancer (other than minor skin cancers or in-situ cervical cancer) within the past 5 years
* Currently pregnant or breastfeeding
* Taking (or soon to begin) drugs that change bone turnover (e.g., bisphosphonates, steroids)
* Diseases that disturb bone metabolism (except common osteoporosis)
* Auto-immune disease or known allergy to porcine collagen or study materials
* Active infection at the planned graft site
* Current use of systemic blood thinners (anticoagulants or antiplatelet agents; e.g., warfarin, heparin/LMWH, DOACs such as apixaban/rivaroxaban/dabigatran/edoxaban, or P2Y12 inhibitors such as clopidogrel/prasugrel/ticagrelor)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT07440303
Study Brief:
Protocol Section:
NCT07440303