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 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
NCT ID:
NCT03690635
Eligibility Criteria:
Inclusion Criteria:
1. Patients 18 years or older.
2. Periodontally and systemically healthy.
3. Presence of at least one Miller class I or II buccal gingival recession defect ≥1 and \<6 mm in depth (Miller 1985)
4. Teeth to be treated: Upper and lower central and lateral incisors, canine, first and second premolars, and first molar
5. Full-mouth plaque and bleeding scores ≤ 20%, no pocket depths \>3 mm, no active periodontal Disease.
6. Clinical indication and/or patient request for recession coverage.
7. Radiographic evidence of sufficient interdental bone (i.e., the distance between the crestal bone and the cementoenamel junction is not greater than two mm)
8. Gingival thickness of at least 0.5mm at a point located three mm below the free gingival margin.
9. A minimum of two mm of keratinized gingiva (thick biotype).
Exclusion Criteria:
1. Miller class III or IV recession defects.
2. Thin biotype , gingival thickness less than or equal 0.5
3. Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
4. Handicapped and mentally retarded patients.
5. Teeth with cervical restorations, abrasion.
6. Patients unable to undergo minor oral surgical procedures.
7. Patients with a history of drug or alcohol abuse.
8. Patients with a history of psychiatric disorder.
9. Pregnant females.
10. Uncontrolled periodontal disease or patient unwillingness to undergo needed periodontal therapy around remaining teeth.
11. Patients who have any systemic condition that may contraindicate any other surgical procedures such as bleeding disorders, uncontrolled diabetes mellitus and immune compromised patients such as HIV patients.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT03690635
Study Brief:
Protocol Section:
NCT03690635