PMCF Study on the Effectiveness and Safety of BIODENTOSS® and DWC® Dental Implants and Superstructures

Post-Market Clinical Follow-Up (PMCF) Study on the Effectiveness and Safety of BIODENTOSS® and DWC® Dental Implants and Superstructures

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.

The study evaluates safety by monitoring the incidence of complications and adverse events, while efficacy is assessed through implant survival/success rates, implant stability, marginal bone loss (MBL), chewing function, and oral health-related quality of life (OHRQoL). Participants will be followed across 10 visits (baseline and 9 follow-up visits) including prosthetic restoration at 3-4 months and final evaluation at 24 months post-implantation.

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.