💬In plain words
What the trial is, and whether it could suit you
This prospective, single-center, interventional post-market clinical follow-up (PMCF) study aims to evaluate the early-term (24 months post-implantation) safety and efficacy of CE-marked BIODENTOSS® and DWC ® Dental Implants and Superstructures in patients requiring dental restoration for tooth loss.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 18 years of age or older,
* Male or female,
* Subjects with missing tooth who require dental implant treatment,
* At least 2 months elapsed since tooth extraction,
* General health status suitable for implantation,
* Not legally restricted (e.g., soldier, convict),
* Provision of signed Informed Consent Form (ICF)
Exclusion Criteria:
* Suspected or confirmed pregnancy or breastfeeding,
* Disorders preventing adequate daily oral hygiene,
* Hypersensitivity/allergy to titanium or implant components,
* Inappropriate interarch relationship or parafunction (e.g., bruxism),
* Bone/soft tissue deficiency requiring augmentation,
* Active periodontal infection or untreated oral pathologies,
* Unstable systemic diseases affecting wound healing (e.g., diabetes),
* Use of immunosuppressive drug therapy due to systemic disorders, organ transplantation, or any other medical conditions,
* Hematological disorders or current use of anticoagulants (such as Warfarin, dabigatran or related therapies),
* Presence of osteoporosis and/or any disease condition affecting bone metabolism,
* Presence of an active systemic infection, or any health condition or ongoing treatment (e.g., radiotherapy, bisphosphonate therapy) that contraindicates elective surgery,
* Recent myocardial infarction or cerebrovascular event,
* Individuals who consume high doses of alcohol, cigarettes, or tobacco products and are unable to control their usage,
* Participation in another interventional clinical study.