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 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT06028750
Eligibility Criteria:
Inclusion Criteria:
* Subjects who agree to voluntarily sign the informed consent before performing any action related to the study.
* Men or women at least 18 years old.
* Single edentulous spaces or edentulous sections located in maxilla or mandible with a healing period longer than 12 weeks to rehabilitate with implant-supported fixed crowns ≤3 units.
* O'Leary plaque and/or bleeding on probing index ≤25%.
Exclusion Criteria:
* Systemic diseases that may interfere with dental implant placement.
* Any contraindications for oral surgical procedures.
* History of head and neck radiotherapy.
* Patients smoking \>20 cigarettes/day or tobacco equivalents.
* History of substance abuse (drugs or alcohol) or any other factor (e.g., severe psychiatric illness) that, in the opinion of the investigator, could interfere with the patient's ability to cooperate and comply with the study.
* Patients who have participated in a clinical trial within the last 30 days.
* Pregnant or lactating women.
* Patients with poor or unmotivated oral hygiene.
* Probing depth with bleeding of ≥4 mm in one of the teeth adjacent to the edentulous space or tract.
* Need to perform guided bone regeneration procedures simultaneous to implant placement.
* Cases where the use of transepithelial abutments is not recommended (reduced prosthetic space, high esthetic demand associated with thin gingival biotypes, etc.).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06028750
Study Brief:
Protocol Section:
NCT06028750