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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT05668494
Eligibility Criteria:
Inclusion Criteria:
* Minimum age of 25 years
* In need of a one or two implants.
* Healed site (healed site defined by restored gingiva, free of inflammation and scar tissue , with a keratinized band of 3mm from crest to muco-gingival junction, and sufficient osseous architecture to receive an implant with a minimal diameter of 3.5 mm).
* Mandible second premolar or molar region.
* At least one neighboring tooth to be present.
* Absence of visible active periapical or periodontal inflammation.
* Adequate oral hygiene: PI\< 20%, BoP\< 20%.
* Sufficient occlusal units mesial or distal and antagonizing, including the diastema to be restored: 4 occlusal units.
Exclusion Criteria:
* Medical condition that contraindicates surgery: ASA -score ≥ III
* History of radiotherapy in the head and neck region.
* History of Bisphosphonate medication.
* Medium smokers ≥ 10 cigarettes per day.
* Patients unwilling or incapable of understanding and signing the informed consent.
* Active caries.
* Presence of inflammation expressed by PPD \>4mm and BoP on adjacent teeth.
* Active periapical radiolucency or root canal treatment performed \< 4 months previous to planned implant insertion on a neighboring tooth to future implant.
* Insufficient restorative space.
* Interocclusal plane distance \< 20mm at planed implant position.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
50 Years
Study:
NCT05668494
Study Brief:
Protocol Section:
NCT05668494