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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT06378502
Eligibility Criteria:
Inclusion Criteria:
Healthy volunteers requiring one single implant or partial implant-supported rehabilitation in an edentulous area of the posterior mandible or maxilla
Exclusion Criteria:
* Patients unable to commit to follow-up
* General contraindications to implant surgery
* Immuno-suppressed/immune-compromised patients
* Patients irradiated in the head and/or neck
* Uncontrolled diabetes
* Pregnancy, childbearing potential, breastfeeding
* Smoking habit
* Untreated periodontal disease (Caton et al, J Clin Periodontol 2018)
* Poor oral hygiene and motivation (plaque index \> 20%)
* Addiction to alcohol or drugs
* Psychiatric problems and/or unrealistic expectations
* Patients with an acute infection (abscess) or suppuration in the site intended for implant placement
* Patients treated or under treatment with intravenous amino-bisphosphonates
* Patients referred only for implant placement if the follow-up cannot be done at the treatment center
* Patients participating in other studies, if the present protocol could not be fully adhered to
* Patients with allergy/hypersensitivity to penicillin or drug excipients
* Patients recently treated with antibiotics for other indications
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT06378502
Study Brief:
Protocol Section:
NCT06378502