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Recruiting NCT07633665

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

No phase Interventional Tooth Loss Edentulism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BIODENTOSS Bone-Level Dental Implant and Superstructures, DWC Bone-Level Dental Implant and Superstructures.
Who it may be relevant to
Registry conditions: Tooth Loss, Edentulism. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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 p
  • 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 pr

Primary outcome measures

  • Implant Success and Satisfactory Survival Rate [Time frame: 6, 12, 18, and 24 months post-implantation.]
  • Implant Stability Measured by Resonance Frequency Analysis [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 [Time frame: At 6, 12, 18, and 24 months post-implantation (all post-loading follow-up visits).]
  • Incidence of Complications and Adverse Events [Time frame: Throughout the 24-month follow-up period.]
Secondary outcome measures (3)
  • Marginal Bone Loss (MBL) [Time frame: 6, 12, 18, and 24 months post-implantation.]
  • Chewing Function and Chewing Satisfaction [Time frame: Baseline and 6, 12, 18, 24 months.]
  • Oral Health-Related Quality of Life (OHRQoL) [Time frame: Baseline and 6, 12, 24 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • Selcuk University, Faculty of Dentistry, Dept. of Oral and Maxillofacial Surgery. — Konya

Identifiers

NCT: NCT07633665 · INFO_CLC_2301 · 2024-170

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗