NCT07633665 PMCF Study on the Effectiveness and Safety of BIODENTOSS® and DWC® Dental Implants and Superstructures
| NCT ID | NCT07633665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Değirmenci Otomotiv ve Metal Endüstri A.Ş. |
| Condition | Tooth Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-12-11 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-12-11 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Abdullah Kalayci, Professor
PRINCIPAL INVESTIGATOR
Selcuk University Faculty of Dentistry
Frequently Asked Questions
Who can join the NCT07633665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tooth Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07633665 currently recruiting?
Yes, NCT07633665 is actively recruiting participants. Contact the research team at kaliteyonetimi@dome.com.tr for enrollment information.
Where is the NCT07633665 trial being conducted?
This trial is being conducted at Konya, Turkey (Türkiye).
Who is sponsoring the NCT07633665 clinical trial?
NCT07633665 is sponsored by Değirmenci Otomotiv ve Metal Endüstri A.Ş.. The principal investigator is Abdullah Kalayci, Professor at Selcuk University Faculty of Dentistry. The trial plans to enroll 80 participants.