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

NCT07633665 | Recruiting

• 2 other identifiers: INFO_CLC_23012024-170
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Loss; Edentulism

Keywords

Post-Market Clinical Follow-Up (PMCF); Dental Implants; Osseointegration; Implant Stability; Marginal Bone Loss (MBL)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Marginal Bone Loss (MBL)

  6, 12, 18, and 24 months post-implantation.

• Chewing Function and Chewing Satisfaction

  Baseline and 6, 12, 18, 24 months.

• Oral Health-Related Quality of Life (OHRQoL)

  Baseline and 6, 12, 24 months.

Study Arms (2)

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.

Device: BIODENTOSS Bone-Level Dental Implant and Superstructures

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.

Device: DWC Bone-Level Dental Implant and Superstructures

Interventions

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.

BIODENTOSS Cohort

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.

DWC Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Değirmenci Otomotiv ve Metal Endüstri A.Ş.: lead

Study Sites (1)

Selcuk University, Faculty of Dentistry, Dept. of Oral and Maxillofacial Surgery.

Konya, 42130, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Abdullah Kalayci, Professor

  Selcuk University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdullah Sari, Met. Eng.

CONTACT

+90 (332) 516 16 91; kaliteyonetimi@dome.com.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 8, 2026
• Study Start: December 11, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)