Biodontoss and DWC dental implants and superstructures in adults needing tooth replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center PMCF study follows adults needing dental implants to assess early-term safety and effectiveness of CE-marked BIODENTOSS and DWC implants and their prosthetic components over 24 months. Safety will be measured by tracking complications and adverse events, while efficacy will focus on implant survival, stability, marginal bone loss, chewing function, and oral health-related quality of life. Participants will have 10 study visits, with prosthetic restoration at 3–4 months and final assessment at 24 months post-implantation. The study uses standard implant procedures and collects clinical and patient-centered outcomes to support post-market surveillance. Enrollment targets adults meeting predefined inclusion criteria and excluding conditions that could confound healing or demonstrate the implant's performance in real-world settings.

Why it matters

Who can join: the full rules

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.

Where it's running

• Selcuk University, Faculty of Dentistry, Dept. of Oral and Maxillofacial Surgery.
  Konya, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Abdullah Kalayci, Professor — Selcuk University Faculty of Dentistry
• Study coordinator: Abdullah Sari, Met. Eng.
• Email: kaliteyonetimi@dome.com.tr
• Phone: +90 (332) 516 16 91

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.