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PMCF Study on the Effectiveness and Safety of BIODENTOSS® and DWC® Dental Implants and Superstructures
Sponsor: Değirmenci Otomotiv ve Metal Endüstri A.Ş.
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.
Official title: Post-Market Clinical Follow-Up (PMCF) Study on the Effectiveness and Safety of BIODENTOSS® and DWC® Dental Implants and Superstructures
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-12-11
Completion Date
2028-07-31
Last Updated
2026-06-08
Healthy Volunteers
No
Conditions
Interventions
BIODENTOSS Bone-Level Dental Implant and Superstructures
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.
DWC Bone-Level Dental Implant and Superstructures
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)
Selcuk University, Faculty of Dentistry, Dept. of Oral and Maxillofacial Surgery.
Konya, Turkey (Türkiye)