PMCF Study on the Effectiveness and Safety of BIODENTOSS® and DWC® Dental Implants and Superstructures

Post-Market Clinical Follow-Up (PMCF) Study on the Effectiveness and Safety of BIODENTOSS® and DWC® Dental Implants and Superstructures

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.

Study Overview

• Status: Recruiting
• Conditions: Tooth Loss; Edentulism
• Intervention / Treatment: Device: BIODENTOSS Bone-Level Dental Implant and Superstructures; Device: DWC Bone-Level Dental Implant and Superstructures

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdullah Sari, Met. Eng.; Phone Number: +90 (332) 516 16 91; Email: kaliteyonetimi@dome.com.tr

Study Locations

• Turkey (Türkiye)
  • Konya, Turkey (Türkiye), 42130
    • Recruiting
    • Selcuk University, Faculty of Dentistry, Dept. of Oral and Maxillofacial Surgery.
    • Contact: Abdullah Kalayci, Professor; Phone Number: +90 (536) 543 25 87; Email: abdullahkalayci@hotmail.com
    • Sub-Investigator: Serhan Akman, Professor
    • Sub-Investigator: Tuba Yilmaz Savas, Asst. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIODENTOSS Cohort; 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; 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.
Experimental: DWC Cohort; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).
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.

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Değirmenci Otomotiv ve Metal Endüstri A.Ş.
• Investigators: Principal Investigator: Abdullah Kalayci, Professor, Selcuk University Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: May 31, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Osseointegration; Dental Implants; Post-Market Clinical Follow-Up (PMCF); Implant Stability; Marginal Bone Loss (MBL)
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: INFO_CLC_2301; 2024-170 (Other Identifier: Turkish Medicines and Medical Devices Agency (TITCK))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared due to confidentiality and intellectual property policies of the sponsor.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No