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:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT03032094
Eligibility Criteria:
Inclusion Criteria:
1. Age\>18 years old
2. Absence of active periodontal disease
3. Single tooth (premolars and anterior teeth) with Miller class I or II gingival recession \>= 2mm
4. Detectable Cemento-Enamel Junction (CEJ) -
Exclusion Criteria:
1. Smokers (\>10 cigarettes/ per day)
2. Uncontrolled systemic diseases with compromised healing potential (DM with HbA1c \>7%)
3. Active infectious diseases (hepatitis, tuberculosis, HIV, etc.)
4. Medication known to cause gingival enlargement
5. Patients taking anticoagulants with an international normalized ratio (INR) \>2.5
6. Long-term (\>2 weeks) use of antibiotics in the past 3 months
7. Pregnant or attempting to get pregnant
8. Sites with probing depth \> 4mm
9. Recession adjacent to an edentulous area
10. Frenal and muscle attachment that encroach on the marginal gingiva
a. Can be included 2 months after surgical therapy to remove the frenum (frenectomy)
11. History of periodontal surgical treatment of the involved sites
12. Prosthetic crown, restorations or caries in the candidate tooth and adjacent teeth
13. Teeth with pulpal pathology
14. Severe teeth malposition and open contacts
15. Planned orthodontic treatment to commence within 1 year following procedure
16. Parafunctional habits -
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03032094
Study Brief:
Protocol Section:
NCT03032094