NCT07586774招募中不适用
An Open, Single-center, Prospective, Randomized, Two-armed, Interventional, Post-market Clinical Investigation of 3D Printed Complete Dentures and Milled Complete Dentures During a 5-year Follow-up Period
Dentsply Sirona Implants and Consumables2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年9月11日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 2
研究概览
简要总结
This is a two-armed, single-center clinical study evaluating performance, efficacy and safety of three dimensional (3D) printed complete dentures and milled complete dentures during a 5-year follow-up period. The primary objective of this clinical investigation is to evaluate survival rate, i.e. subjects with survived dentures in both upper and lower jaw, of 3D printed complete dentures and milled complete dentures after 1 year (in each of the groups separately).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Adult aged 18 years or above at time of informed consent.
- •Subject willing to participate in the clinical investigation and able to understand the content of the clinical investigation.
- •Subject willing to comply with investigational related procedures and to return for follow-up visits for a period of 5 years.
- •Subject has signed and dated the informed consent form.
- •Subjects in need of complete dentures in maxilla and mandible.
- •Prosthodontic Diagnostic Index (PDI) Completely edentulous classification (Class 1-3).
- •History of edentulism of at least 1 year.
排除标准
- •Known allergy or hypersensitivity to any of the components.
- •Subjects with significant systemic health issues or chronic conditions (American Society of Anesthesiologists (ASA) class 3-6 ).
- •Known pregnancy at time of enrolment.
- •Subjects unlikely to comply with investigational procedures, or unlikely to come back for follow-up visits, as judged by the Investigator.
- •Previous enrolment in the present clinical investigation.
- •Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and the clinical investigation site).
- •PDI Completely edentulous classification (Class 4)
- •Presence of severely atrophied ridge.
- •Presence of severe ridge undercuts.
- •Clinically severe Xerostomia.
- •Absence of hard or soft tissue pathology that precludes denture therapy.
- •Maxillofacial defects.
- •Uncontrolled pathological process in the oral cavity, as judged by the Investigator.
- •Participation in another clinical investigation that may interfere with the present clinical investigation.
研究组 & 干预措施
3D printed dentures
Experimental
3D printed denture bases and 3D printed denture teeth.
干预措施: Lucitone Digital Print (Device)
Milled dentures
Experimental
Milled denture bases and denture teeth.
干预措施: Lucitone Digital Fit (Device)
研究者
研究点 (2)
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