Edentulism, Tooth Loss
Conditions
Keywords
Post-Market Clinical Follow-Up (PMCF), Dental Implants, Osseointegration, Implant Stability, Marginal Bone Loss (MBL)
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.
Detailed description
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.
Interventions
DEVICEBIODENTOSS 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.
DEVICEDWC Bone-Level Dental Implant and Superstructures
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.
Sponsors
Değirmenci Otomotiv ve Metal Endüstri A.Ş.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Success and Satisfactory Survival Rate | 6, 12, 18, and 24 months post-implantation. | 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. |
| Implant Stability Measured by Resonance Frequency Analysis | Immediate post-implantation (baseline) and pre-loading (at 3 months for mandibular implants or 4 months for maxillary implants) | 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. |
| Percentage of Implants With Zero Clinical Mobility | At 6, 12, 18, and 24 months post-implantation (all post-loading follow-up visits). | 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. |
| Incidence of Complications and Adverse Events | Throughout the 24-month follow-up period. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone Loss (MBL) | 6, 12, 18, and 24 months post-implantation. | Radiographic assessment of bone level changes (mesial/distal) using digital panoramic/periapical radiographs. |
| Chewing Function and Chewing Satisfaction | Baseline and 6, 12, 18, 24 months. | 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). |
| Oral Health-Related Quality of Life (OHRQoL) | Baseline and 6, 12, 24 months. | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAbdullah Sari, Met. Eng.
PRINCIPAL_INVESTIGATORAbdullah Kalayci, Professor
Selcuk University Faculty of Dentistry
Outcome results
None listed