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 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT06081192
Eligibility Criteria:
Inclusion Criteria:
* ≥ 60 years of age
* healed dentulous maxillary arch (minimum of twelve weeks since the last extraction)
* wearing a complete maxillary denture evaluated as sufficient for surgical planning
* minimal ridge dimensions of 5.4 mm (width) by 12 mm (height) in the anterior and premolar maxillary area
* bone dimensions allowing the placement of one-piece implants with a 2.4 mm-diameter and minimum length of 10 mm.
* general health condition should be a physical status ASA1 or ASA2.
Exclusion Criteria:
* inability to perform adequate oral hygiene
* incapability to provide written informed consent and compliance to the protocol
* any contraindication for oral surgery such as but not limited to,
* uncontrolled diabetes
* immunosuppression
* radiation or chemotherapy
* antiresorptive medication such as bisphosphonates
* presence of dental, periodontal or peri-implant disease in the opposing arch
* presence of a conventional complete denture in the opposing arch (mandible)
* presence of an insufficient partial removable denture or implant-overdenture in the opposing arch, which cannot be rendered sufficient by a reline
* heavy smoking habit with \> 20 cig/d
* reported severe bruxism or clenching habits
* clinically present oro-facial pain
* depression with a Geriatric Depression Scale above 12
* xerostomia with a stimulated salivary flow rate inferior to 0.7 ml/min
* ridge morphology type IV (Cawood and Howell, 1988)
* defects requiring bone augmentation procedures, or unhealthy soft tissues.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT06081192
Study Brief:
Protocol Section:
NCT06081192