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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07436533
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 years or older, including both genders.
* Healed edentulous sites (short or long spans, single or multiple missing teeth) in maxillary or mandibular arches.
* At least 6 months post-extraction period (delayed implant placement).
* Alveolar ridge width of 3-5 mm at the crest (buccolingually).
* Low-density jaw regions (D1-D5 according to Misch classification).
* Presence of ≥ 2 mm trabecular bone core and trabecular-to-cortical bone ratio of ≥ 1:1.
* Sufficient vertical dimensions as assessed via CBCT.
* Straightforward cases according to SAC classification (Beagle, 2013).
* Well-motivated patients willing to attend follow-up visits and maintain good oral hygiene.
Exclusion Criteria:
* Acute or chronic infection or pathological condition at the proposed implant site.
* Severe buccal plate undercut or concavity.
* Signs of active infection in the implant zone.
* Severe parafunctional habits such as bruxism or clenching.
* Heavy smoking (more than 10 cigarettes per day).
* Inadequate inter-ridge distance or insufficient vertical height for implant placement.
* Use of medications compromising bone healing (e.g., corticosteroids, hormone replacement therapy, or bisphosphonates).
* Uncontrolled systemic diseases (e.g., diabetes, immunocompromised states, hyperparathyroidism, or fibrous dysplasia).
* History of radiotherapy to the head/neck or chemotherapy within the past 5 years.
* Current pregnancy during the surgical procedure.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07436533
Study Brief:
Protocol Section:
NCT07436533