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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT04225351
Eligibility Criteria:
Inclusion Criteria:
* multiple (i.e., at least 2) Miller Class I and/or II gingival recessions located in the maxillary, with an apico-coronal extension (i.e., defect depth \> 1 mm with at least one defect \> 2 mm) and with at least 1 mm of residual keratinized tissue,
* good general health, with no systemic diseases that could influence the outcome of the therapy,
* healthy periodontal conditions (i.e., no presence of sites ≥ 4 mm and/or presence of intra-bony defects in the selected sites),
* adequate oral hygiene (full mouth plaque score (FMPS) of \<25% at baseline (following initial oral hygiene instructions and prophylaxis),
* an adequate control of inflammation (full mouth bleeding score \[FMBS\]) of \<25% at baseline (following initial oral hygiene instructions and prophylaxis).
Exclusion Criteria:
* subjects who currently smoke \>10 cigarettes/day,
* female subjects who are nursing, pregnant, or plan to become pregnant,
* contraindication against oral surgical interventions,
* contraindication against use of Fibro-Gide (acute infection in the area of surgery and patient with collagen allergy)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04225351
Study Brief:
Protocol Section:
NCT04225351