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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT06679894
Eligibility Criteria:
Inclusion Criteria:
* Age older than 18 years old;
* Indication for an implant-supported rehabilitation in the upper premolar / first molar areas;
* The area in which the implants will be placed must have had at least 6 months of healing;
* No use of grafts or bone substitutes following tooth extraction;
* Bone volume measuring at least 10 mm in height and 6 mm in width;
* In case of two adjacent implants the distance between the natural teeth must be at least 14 mm, composed by twice the width of each implant (4 mm), the distance between them (at least 3 mm) and twice the distance between each teeth (at least 1,5 mm)
* Bone quality belonging to class D3 or D4, following Misch classification
* Absence or decision to not wear a removable prosthesis during the healing period;
* Patients with good and stable oral hygiene;
* Signed informed consent form.
Exclusion Criteria:
* Acute myocardial infarction within the previous six months;
* Uncontrolled bleeding disorders;
* Uncontrolled diabetes (HBA1c \> 7.5%);
* Radiotherapy in the head-neck area in the previous 48 months;
* Immunocompromised patients (es. AIDS / chemotherapy);
* Current or previous treatment with antiresorptive drugs via intravenous injection;
* Psychological or psychiatric disease;
* Alcohol and /or drugs abuse;
* Heavy smokers (more than 10 cigarettes / day);
* Plaque index \>20% and/or bleeding on probing \>10%
* Pregnant or breastfeeding patients;
* Patients refusing to participate in follow-up checks.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06679894
Study Brief:
Protocol Section:
NCT06679894