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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT04091802
Eligibility Criteria:
Inclusion Criteria:
* 1\. Patients diagnosed with black triangles. 2. Both genders aged from 18-40 years. 3. Patients should be systemically free. 4. Patients with Nordland's class I or II. Nordland and Tarnow classified the interdental papilla loss; the classification is based on three anatomic landmarks: the contact point interdentally, the coronal level of the CEJ interproximally and the facial apical level of the cemento-enamel junction (CEJ). \[Nordland WP, et al, 1998\] Four classes were identified
* Normal: The interdental papilla fills up the whole embrasure to the interproximal contact point.
* Class I: Presence of the tip of the papilla between interdental contact point and the interproximal CEJ.
* Class II: Presence of the tip of the papilla at the interproximal CEJ or apical to it but still coronal to the facial CEJ.
* Class III: Presence of the tip of papilla at similar plane with the labial CEJ or apical to it.
5\. The vertical distance from the interdental contact point to the crest of the interdental bone is ≥ 6 mm as measured by bone sounding.
6\. A band of keratinized tissue should be present around the test teeth ≥ 2 mm. 7. Gingival biotype of the area to be treated is ≥ 2 mm in thickness.
Exclusion Criteria:
1. Acute periapical lesion.
2. moderate to severe form of periodontitis.
3. Pregnancy and lactation.
4. parafunctional habits.
5. Smoking, alcoholics or drug abusers.
6. Teeth with interdental spacing, rotation or inclination or crowding.
7. Vulnerable group of patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04091802
Study Brief:
Protocol Section:
NCT04091802