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

4 juin 2026 mis à jour par: Değirmenci Otomotiv ve Metal Endüstri A.Ş.

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Turquie (Türkiye)
      • Konya, Turquie (Türkiye), 42130
        • Recrutement
        • Selcuk University, Faculty of Dentistry, Dept. of Oral and Maxillofacial Surgery.
        • Contact:
        • Sous-enquêteur:
          • Serhan Akman, Professor
        • Sous-enquêteur:
          • Tuba Yilmaz Savas, Asst. Prof.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.
Expérimental: 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.
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Implant Success and Satisfactory Survival Rate
Délai: 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.
6, 12, 18, and 24 months post-implantation.
Implant Stability Measured by Resonance Frequency Analysis
Délai: 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.
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
Délai: 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.
At 6, 12, 18, and 24 months post-implantation (all post-loading follow-up visits).
Incidence of Complications and Adverse Events
Délai: 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).
Throughout the 24-month follow-up period.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Marginal Bone Loss (MBL)
Délai: 6, 12, 18, and 24 months post-implantation.
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
Délai: 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).
Baseline and 6, 12, 18, 24 months.
Oral Health-Related Quality of Life (OHRQoL)
Délai: 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.
Baseline and 6, 12, 24 months.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Değirmenci Otomotiv ve Metal Endüstri A.Ş.

Les enquêteurs

  • Chercheur principal: Abdullah Kalayci, Professor, Selcuk University Faculty of Dentistry

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

11 décembre 2024

Achèvement primaire (Estimé)

31 mars 2028

Achèvement de l'étude (Estimé)

31 juillet 2028

Dates d'inscription aux études

Première soumission

31 mai 2026

Première soumission répondant aux critères de contrôle qualité

4 juin 2026

Première publication (Réel)

8 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • INFO_CLC_2301
  • 2024-170 (Autre identifiant: Turkish Medicines and Medical Devices Agency (TITCK))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Data will not be shared due to confidentiality and intellectual property policies of the sponsor.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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