Post-Market Clinical Follow-Up (PMCF) Study on the Effectiveness and Safety of BIODENTOSS® and DWC® Dental Implants and Superstructures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.