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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT04678804
Eligibility Criteria:
Inclusion Criteria:
Systemically healthy males and females ≥ 18 years old
* Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained
* Clinical evidence of a single gingival recession (RT1, RT2)
* Full mouth bleeding and plaque scores (FMBS and FMPS) \< 20% recorded
* Non-surgical treatment completed within 6 months prior to assessment for eligibility
Exclusion Criteria:
* Medical history that includes diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases (e.g. cardiovascular disease or AIDS).
* Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
* History of alcohol or drug abuse.
* Smoking ≥10 cigarettes a day
* Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
* Taking medications that might induce gingival overgrowth (e.g. calcium antagonists)
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT04678804
Study Brief:
Protocol Section:
NCT04678804