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
Değirmenci Otomotiv ve Metal Endüstri A.Ş.
80 participants
Dec 11, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria14
- 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.
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Interventions
Surgical placement of CE-marked BIODENTOSS bone-level dental implants, available in conical or cylindrical models, with diameters ranging from 3.4 mm to 6.0 mm and lengths from 7.5 mm to 13 mm. Implants feature an SLA (Sandblasted, Large-grit, Acid-etched) surface texture and a 22-degree conical internal hex connection. Following an osseointegration period, prosthetic restoration will be completed using compatible superstructures, including cover screws, healing abutments, and various types of prosthetic abutments based on clinical indications.
Surgical placement of CE-marked DWC bone-level dental implants, available in cylindrical or active threaded models, with diameters ranging from 3.3 mm to 4.8 mm and lengths from 8 mm to 15 mm. Implants feature an SLA (Sandblasted, Large-grit, Acid-etched) surface texture and a 22-degree conical internal hex connection. Following an osseointegration period, prosthetic restoration will be completed using compatible superstructures, including cover screws, healing abutments, and various types of prosthetic abutments based on clinical indications.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07633665