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 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT05805033
Eligibility Criteria:
Inclusion Criteria:
* Participants have to voluntarily sign the informed consent form before any study related action
* Patients aged 18 or over
* Patients with one or more missing teeth in the maxillary or mandible area, seeking implant therapy
* Men/women
* Patients in good systemic health (ASA I/ II) and no contraindication for oral surgical interventions
* Patients requiring a replacement of missing teeth; the tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation
* At least 3 mm of fibrous mucosa in the bucco-lingual dimension
* Full mouth plaque score (FMPI) lower than or equal to 25%
* At least a diameter of 4 mm for the implant (regular diameter)
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) - patients with gingivitis or active local infection will undergo a medical treatment prior to the entrance to the study, and each individual will be evaluated for suitability; in case of a systemic infection, the evaluation will be based on medical anamneses, and if necessary, a patient will be referred to relevant medical tests
* Current pregnancy or breastfeeding women
* Alcoholism or chronical drug abuse
* Immunocompromised patients
* Uncontrolled diabetes
* Smokers
* Prisoners
* Implant's diameter under 4 mm (narrow implant)
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of the study or interference with analysis of study results, such as history of non-compliance, or unreliability
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05805033
Study Brief:
Protocol Section:
NCT05805033