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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Устройство 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

Первичные конечные точки

• Implant Success and Satisfactory Survival Rate [Срок оценки: 6, 12, 18, and 24 months post-implantation.]
• Implant Stability Measured by Resonance Frequency Analysis [Срок оценки: 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 [Срок оценки: At 6, 12, 18, and 24 months post-implantation (all post-loading follow-up visits).]
• Incidence of Complications and Adverse Events [Срок оценки: Throughout the 24-month follow-up period.]

Вторичные конечные точки (3)

• Marginal Bone Loss (MBL) [Срок оценки: 6, 12, 18, and 24 months post-implantation.]
• Chewing Function and Chewing Satisfaction [Срок оценки: Baseline and 6, 12, 18, 24 months.]
• Oral Health-Related Quality of Life (OHRQoL) [Срок оценки: Baseline and 6, 12, 24 months.]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

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

Идентификаторы

NCT: NCT07633665 · INFO_CLC_2301 · 2024-170

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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