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:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT07016828
Eligibility Criteria:
Inclusion Criteria:
1. Patients with severe posterior maxillary atrophy (Class V-VI Cawood \& Howell classification) requiring pterygoid implant placement.
2. Patients with severe alveolar bone atrophy in posterior maxilla (Residual alveolar bone height \<4mm in posterior maxilla precluding conventional implant placement).
3. Adequate interarch space ≥7mm for prosthetic rehabilitation.
4. Presence of pneumatized maxillary sinus with insufficient bone for sinus augmentation.
5. Patients aged 21-75 years with completed craniofacial growth.
Exclusion Criteria:
1. Patients with systemic conditions contra-indicating general anesthesia.
2. Patients with conditions contraindicating implant placement (e.g.:
radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
3. Patients with acute maxillary sinus infection or maxillary sinus cyst.
4. Restricted mouth opening (less than 3cm inter-arch distance anteriorly).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT07016828
Study Brief:
Protocol Section:
NCT07016828