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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT06408792
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged ≥18 years.
2. Need for soft tissue augmentation in an edentulous space to increase gingival volume simultaneously with placing a dental implant.
3. Patients with a palatal thickness of at least 4mm. This will be measured by overlaying a DICOM file of the CBCT with an STL file of the intraoral scan (Shining 3D). It will be measured at the height of the maxillary 2nd premolar, 5mm from the gingival margin.
4. Patients in whom a de-epithelialized palatal graft measuring 12x5mm can be obtained and which is between 1.5-2mm thick. The thickness will be measured with a digital caliper once it has been de-epithelialized.
5. Patients with no history of previous palatal graft extraction.
6. Patients with the ability to comply with the procedures related to the study, such as maintaining good oral hygiene, filling out the questionnaires and attending follow-up appointments.
7. Patients with the ability to fully understand the nature of the proposed surgery and the ability to understand and sign the informed consent form.
Exclusion Criteria:
1. Presence of vertical bone dehiscence of \>3mm in the buccal area of the edentulous space where the implant will be placed (assessed at the time of surgery).
2. Smokers of more than 10 cigarettes/day
3. Presence of untreated periodontitis.
4. Diabetics
5. Patients being treated with oral anticoagulants or antiplatelet agents.
6. Patients with a history of malignant tumors, head and neck radiotherapy, chemotherapy or immunotherapy treatment in the last 5 years.
7. Patients with a history of previous or current medication that affects wound healing or promotes the appearance of infections, such as the use of corticosteroids, immunosuppressants or immunomodulators.
8. Patients with diseases that affect the metabolism of connective tissue, autoimmune or chronic inflammatory diseases with oral involvement (oral lichen planus, mucosal pemphigoid, pemphigus...), alterations in vascularization in the donor or recipient area, metabolic bone diseases or abuse of alcohol.
9. Patients receiving antiresorptive drugs such as bisphosphonates, denosumab, romosozumab or other drugs associated with osteonecrosis due to drugs such as m-TOR inhibitors, bevacizumab and sunitinib.
10. Pregnant or breastfeeding women.
11. Presence of oral lesions on the palate such as recurrent lesions due to herpes simplex virus.
12. Patients who use removable dental prosthesis that covers the palate.
13. Patients with a history of hypersensitivity to any of the materials used in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06408792
Study Brief:
Protocol Section:
NCT06408792