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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT04139512
Eligibility Criteria:
Inclusion criteria
* Subjects must have voluntarily signed the informed consent form before any study related action
* Age \> 18 years old
* Single missing tooth or 2 non-adjacent missing teeth in the aesthetic area of the upper jaw. Patients who require an extraction and immediate implant placement can be included.
* Men/women
* Good systemic health (ASA I/II)
* No contra indication against oral surgical interventions
* At least 10 mm in the vertical dimension
* At least 7 mm in the bucco-palatal dimension
* No need for simultaneous bone augmentation procedure. However, a bone augmentation could have been realized 4 months prior to the digital planning of the surgery
* Healthy periodontal condition and full mouth plaque score (FMPS) lower or equal than 25%
Exclusion criteria
* Autoimmune disease requiring medical treatment
* Medical conditions requiring prolonged use of steroids
* Use of bisphosphonates intravenously or more than 3 years of oral use
* Infection (local or systemic) Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection will undergo a medical treatment prior to its entrance to the study.
In case of systemic infection, the evaluation will be based on medical anamneses and, if necessary, will be referred to relevant medical tests.
* Current pregnancy or breastfeeding women
* Alcoholism or chronically drug abuse
* Immunocompromised patients
* Uncontrolled diabetes
* Smokers, more than 10 cigarettes per day
Local exclusion criteria
* Untreated local inflammation
* Mucosal disease or oral lesions
* History of local irradiation therapy in the head-neck area
* Persistent intraoral infection
* Patients with bad oral hygiene or unmotivated for normal home care
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04139512
Study Brief:
Protocol Section:
NCT04139512