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

4. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Türkei (türkiye)
      • Konya, Türkei (türkiye), 42130
        • Rekrutierung
        • Selcuk University, Faculty of Dentistry, Dept. of Oral and Maxillofacial Surgery.
        • Kontakt:
        • Unterermittler:
          • Serhan Akman, Professor
        • Unterermittler:
          • Tuba Yilmaz Savas, Asst. Prof.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Gerät: 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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Implant Success and Satisfactory Survival Rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Marginal Bone Loss (MBL)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Değirmenci Otomotiv ve Metal Endüstri A.Ş.

Ermittler

  • Hauptermittler: Abdullah Kalayci, Professor, Selcuk University Faculty of Dentistry

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

11. Dezember 2024

Primärer Abschluss (Geschätzt)

31. März 2028

Studienabschluss (Geschätzt)

31. Juli 2028

Studienanmeldedaten

Zuerst eingereicht

31. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Juni 2026

Zuerst gepostet (Tatsächlich)

8. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • INFO_CLC_2301
  • 2024-170 (Andere Kennung: Turkish Medicines and Medical Devices Agency (TITCK))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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