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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDeğirmenci Otomotiv ve Metal Endüstri A.Ş.

About this trial

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 criteria

Qualifiers

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,

Disqualifiers

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),

Trial design

Treatments tested in this trial

  • BIODENTOSS Bone-Level Dental Implant and Superstructures
  • DWC Bone-Level Dental Implant and Superstructures

Treatment groups

80 Participants
are divided into 2 treatment groups