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 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT05552768
Eligibility Criteria:
Inclusion Criteria:
1. adults 21-75-year old;
2. ASA 1-3 with no medical contraindication for implant surgery;
3. Edentulous site(s) in need of implant-supported fixed restoration of one or up to three units supported by 2 implants;
4. availability of native bone of at least 6 mm in width to accommodate standard Ø 3.75 and 4.2 mm implant without any need for bone augmentation;
5. bone height to accommodate 10 mm long implants accounting for up to 2 mm of subcrestal placement in the mandible and the maxilla;
6. adequate oral hygiene and stable periodontal status with bleeding on probing (BOP) \< 20% and plaque index (PI) \< 30%;
7. keratinized gingiva ≥ 4 mm;
8. willing to sign an informed consent and ability and willingness to comply with all study visits.
Exclusion Criteria:
1. moderate or heavy smoking (≥10 cigarettes per day);
2. systemic diseases preventing implant placement;
3. uncontrolled diabetes (HbA1c ≥ 8%), osteoporosis as confirmed by z/t score, or other conditions or medications affecting bone healing;
4. poor oral hygiene;
5. alcoholism and recreational drug addiction;
6. uncontrolled periodontitis;
7. pregnant or lactating women;
local exclusion criteria
1. Immediate implant placement;
2. socket preservation with a bone substitute biomaterial less than 6 months prior, or 9 months prior for xenografts;
3. vertical (Seibert class II / III defect exceeding 3 mm that would compromise ideal apicocoronal placement);
4. prior ridge augmentation / GBR procedure
5. implant primary stability not enabling torquing the CONNECT abutment at 30 Ncm without rotation;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT05552768
Study Brief:
Protocol Section:
NCT05552768