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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT06051266
Eligibility Criteria:
Inclusion Criteria:
* 18 years old and above
* American society of anesthesiologists (ASA) Levels 1 and 2
* Satisfy any of the following requirements:
1. Edentulous maxillary patients
2. Edentulous mandibular patients
3. Terminally edentulous maxillary patients (number of remaining natural teeth in the upper jaw 1-4)
4. Terminally edentulous mandibular patients (number of remaining natural teeth in the lower jaw 1-4)
5. Full-mouth edentulous patients
6. Full-mouth terminally edentulous patients (number of remaining natural teeth in one jaw 1-4)
* Implant-supported fixed restorations or implant-supported overdenture restorations
* Sufficient usable bone volume at implant sites, non-implant sites (≥1.5mm of remaining bone width on the labial/buccal and palatal/lingual sides after virtual implant placement in software)
* Maxillary and mandibular options for full-mouth patients are based on the inclusion of more single jaws in the non-bone grafted sites (see virtual peri-implant bone volume requirements in the pre-operative preparation phase)
* Mouth opening of 3 fingers or more
* Single-jawed missing patients treated with systemic periodontal therapy
Exclusion Criteria:
* Have a systemic disease that may affect prognosis (e.g. diabetic patients with glycated haemoglobin \>6.5%, patients on bisphosphonate medication, patients with auto-systemic immune diseases, etc.)
* ASA grades 3 and 4
* Acute inflammation in the oral cavity: including uncontrolled periodontitis (periodontal probing depth \> 4 mm) and untreated acute and chronic apical periodontitis
* Pregnancy or breastfeeding
* History of radiotherapy to the head and neck
* Heavy smokers (more than 10 cigarettes per day)
* Restricted mouth opening (less than three fingers).
* Participation in a clinical trial with another drug or device within 30 days prior to the start of the procedure (study day 0).
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06051266
Study Brief:
Protocol Section:
NCT06051266