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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-170 | Other Identifier | Turkish Medicines and Medical Devices Agency (TITCK) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIODENTOSS Cohort | Experimental | 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. |
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| DWC Cohort | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIODENTOSS Bone-Level Dental Implant and Superstructures | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | At 6, 12, 18, and 24 months post-implantation (all post-loading follow-up visits). |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Bone Loss (MBL) | Radiographic assessment of bone level changes (mesial/distal) using digital panoramic/periapical radiographs. | 6, 12, 18, and 24 months post-implantation. |
| Chewing Function and Chewing Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdullah Sari, Met. Eng. | Contact | +90 (332) 516 16 91 | kaliteyonetimi@dome.com.tr |
| Name | Affiliation | Role |
|---|---|---|
| Abdullah Kalayci, Professor | Selcuk University Faculty of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Selcuk University, Faculty of Dentistry, Dept. of Oral and Maxillofacial Surgery. | Recruiting | Konya | 42130 | Turkey (Türkiye) |
Data will not be shared due to confidentiality and intellectual property policies of the sponsor.
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This study is designed to independently evaluate the safety and efficacy of devices in two distinct post-market cohorts. Each arm will be analyzed independently using descriptive and longitudinal statistics; no between-arm hypothesis testing or direct statistical comparison is intended.
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This study utilizes a parallel-group design to independently monitor two distinct post-market device cohorts in routine clinical practice. There are design and size variations between the two implant systems, which makes masking unfeasible. Each cohort is tracked strictly within its own sample to evaluate baseline-to-endpoint safety and performance; no between-arm hypothesis testing or direct statistical comparison is intended.
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| DWC Bone-Level Dental Implant and Superstructures | Device | 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. |
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| 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). | Throughout the 24-month follow-up period. |
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).
| 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. | Baseline and 6, 12, 24 months. |
| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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