An interventional study of BIODENTOSS Bone-Level Dental Implant and Superstructures and DWC Bone-Level Dental Implant and Superstructures in Tooth Loss and Edentulism, sponsored by Değirmenci Otomotiv ve Metal Endüstri A.Ş.. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Değirmenci Otomotiv ve Metal Endüstri A.Ş. · Not applicable, Interventional, and Other
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.
The study evaluates safety by monitoring the incidence of complications and adverse events, while efficacy is assessed through implant survival/success rates, implant stability, marginal bone loss (MBL), chewing function, and oral health-related quality of life (OHRQoL). Participants will be followed across 10 visits (baseline and 9 follow-up visits) including prosthetic restoration at 3-4 months and final evaluation at 24 months post-implantation.
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's planned enrollment of 80 is above the median of 30 across 120 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →This is the only study on the registry with Değirmenci Otomotiv ve Metal Endüstri A.Ş. as lead sponsor.
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Exclusion Criteria:
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort includes participants receiving BIODENTOSS bone-level dental implants (conical or cylindrical models) and compatible superstructures for the restoration of missing teeth. Patients will undergo standard surgical implantation followed by prosthetic restoration at 3 to 4 months post-implantation. Safety and efficacy outcomes-including implant survival/success rates, stability, marginal bone loss, chewing function, and oral health-related quality of life-will be monitored prospectively across a 24-month follow-up period. Data collected for this cohort will be analyzed and reported independently via descriptive and longitudinal statistics, with no statistical comparison intended against other cohorts.
Device: BIODENTOSS Bone-Level Dental Implant and Superstructures
This cohort includes participants receiving DWC bone-level dental implants (cylindrical or active threaded) and compatible superstructures for the restoration of missing teeth. Patients will undergo standard surgical implantation followed by prosthetic restoration at 3 to 4 months post-implantation. Safety and efficacy outcomes-including implant survival/success rates, stability, marginal bone loss, chewing function, and oral health-related quality of life-will be monitored prospectively across a 24-month follow-up period. Data collected for this cohort will be analyzed and reported independently via descriptive and longitudinal statistics, with no statistical comparison intended against other cohorts.
Device: DWC 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.
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.
Implant Success and Satisfactory Survival Rate
The percentage of functional implants in each cohort meeting the 2007 International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference Health Scale criteria. Multiple clinical/radiographic parameters (pain, mobility, bone loss, exudate) are aggregated to classify each implant into a single category: Group I (Success: no pain/mobility, \<2mm bone loss, no exudate); Group II (Satisfactory Survival: no pain/mobility, 2-4mm bone loss, no exudate); Group III (Compromised Survival: potential sensitivity, no mobility, \>4mm bone loss \[\<50% of implant body\], pocket depth \>7mm, potential exudate); or Group IV (Failure: pain, mobility, bone loss \>1/2 implant length, or uncontrolled exudate). To arrive at the single reported value, data are aggregated by calculating the combined percentage of implants classified into Group I and Group II out of the total implants evaluated in each cohort.
Time frame: 6, 12, 18, and 24 months post-implantation.
Implant Stability Measured by Resonance Frequency Analysis
Quantitative assessment of implant stability within each independent cohort using non-invasive Resonance Frequency Analysis (RFA). Individual implant stability will be reported based on the Implant Stability Quotient (ISQ) scale, ranging from 1 to 100. Higher values indicate greater stability, with an ISQ score ≥ 70 reflecting high stability.
Time frame: Immediate post-implantation (baseline) and pre-loading (at 3 months for mandibular implants or 4 months for maxillary implants)
Percentage of Implants With Zero Clinical Mobility
Assessment of post-loading implant stability evaluated via manual clinical examination. Clinical stability is measured by vertical and horizontal forces and graded using Mühlemann's Mobility Index, which ranges from 0 to 4 (where 0 indicates normal/physiological movement and 4 indicates vertical mobility). The single reported value will be the percentage of implants within each independent cohort achieving a mobility index score of "0" (lack of clinical mobility), indicating successful osseointegration.
Time frame: At 6, 12, 18, and 24 months post-implantation (all post-loading follow-up visits).
Incidence of Complications and Adverse Events
Safety data will be collected by recording all adverse events (AEs) and complications encountered during the 24-month follow-up period. This includes intraoperative complications (e.g., bone fenestration/dehiscence, nerve injury), device-related failures (e.g., implant fracture, loss of stability), and any postoperative adverse events (e.g., infection, peri-implant mucositis, or prosthetic component loosening).
Time frame: Throughout the 24-month follow-up period.
Marginal Bone Loss (MBL)
Radiographic assessment of bone level changes (mesial/distal) using digital panoramic/periapical radiographs.
Time frame: 6, 12, 18, and 24 months post-implantation.
Chewing Function and Chewing Satisfaction
Assessed independently within each cohort. Chewing function will be verified via clinical occlusion control using articulation paper. Patient chewing satisfaction will be scored directly by the participant using a 5-point Likert scale (ranging from 1: not satisfied at all, to 5: very satisfied).
Time frame: Baseline and 6, 12, 18, 24 months.
Oral Health-Related Quality of Life (OHRQoL)
Assessed independently within each cohort using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The scale consists of 14 items scored on a Likert scale, with total scores ranging from 0 to 56. Lower overall scores indicate superior OHRQoL and better clinical outcomes.
Time frame: Baseline and 6, 12, 24 months.
Plan to share: No — Data will not be shared due to confidentiality and intellectual property policies of the sponsor.
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Mar 2028, 39 months after the start.
Of 77 interventional studies with no phase under Tooth Loss, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 39 months is above that.
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