跳至主要内容
临床试验/NCT06960070
NCT06960070招募中不适用

One-year Clinical Evaluation of Onlay Restorations Fabricated With Three Different Additive Manufacturing Resins in Endodontically Treated Teeth: A Prospective Study

Mersin University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年6月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
2
主要终点
Clinical performance

研究概览

简要总结

Additive manufacturing, also referred to as "3D printing" or "rapid prototyping," is defined as the process of joining materials layer by layer to create an object based on 3D model data. In this method, a digital data set is first created on a computer (computer-aided design, CAD) and then transferred to a 3D printer. The designed object is produced by printing it in successive layers.

In contrast, in subtractive manufacturing, restorations are produced by milling homogeneous blocks based on computer-designed models. Compared to subtractive manufacturing technology, additive manufacturing allows for the production of more complex, detailed, and larger structures with much less material waste and without excessive use of force.

It is thought that additive manufacturing has the potential to overcome the disadvantages of subtractive manufacturing. Over the past decade, global sales of industrial and personal 3D printers, materials, and services have increased by more than 33% annually.

Due to its success in the production of surgical guides, temporary and permanent restorations, crowns and bridges, occlusal splints, frameworks, and orthodontic appliances, this technology has attracted significant interest in the field of dentistry.

Although additive manufacturing has started to be used as an alternative to subtractive manufacturing in many applications, there is still a lack of information regarding the chemical composition, mechanical, and physical properties of printable resins. Moreover, clinical data on the use of these resins in permanent restorations are quite limited.

Therefore, the aim of this study is to clinically evaluate and monitor for one year the performance of onlay restorations fabricated with three different resins of varying compositions in endodontically treated teeth.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Molar teeth that have undergone root canal treatment
  • •Teeth with proximal defects located above the gingival margin
  • •Defects limited to the occlusal surface and a single adjacent surface
  • •Presence of an occlusal defect extending over one-third of the distance between the fissure and the cusp tip and involving one or more cusps
  • •Presence of an opposing tooth or a fixed prosthetic restoration against the tooth to be restored
  • •Presence of adjacent teeth next to the tooth to be restored

排除标准

  • •Fractured or cracked teeth
  • •Patients with temporomandibular joint disorders
  • •Patients with bruxism (teeth grinding)
  • •Molar teeth without an opposing tooth or fixed prosthetic restoration
  • •Molar teeth without adjacent teeth
  • •Vital teeth
  • •Patients with a history of allergy to the components of the resins

研究组 & 干预措施

Saremco print resin

Active Comparator

干预措施: Saremco print resin (Device)

Varseosmile Crownplus resin

Active Comparator

干预措施: Varseosmile Crownplus resin (Device)

Varseosmile TriniQ resin

Active Comparator

干预措施: Varseosmile TriniQ resin (Device)

结局指标

主要结局

Clinical performance

时间窗: Baseline- 6 months-12 months

The clinical evaluation of restorations bonded to teeth will be performed at baseline, at 6 months, and at 12 months using the World Dental Federation (FDI) criteria which are divided into 3 main categories as functional, biological and esthetic properties. Each property is typically scored on a 1 to 5 scale: 1. \- Clinically excellent 2. \- Clinically good 3. \- Clinically sufficient 4. \- Clinically insufficient 5. \- Clinically poor

Clinical performance

时间窗: Baseline- 6 months-12 months

The clinical evaluation of restorations bonded to teeth will be performed at baseline, at 6 months, and at 12 months using the World Dental Federation (FDI) criteria which are divided into 3 main categories as functional, biological and esthetic properties. Each property is typically scored on a 1 to 5 scale: 1. \- Clinically excellent 2. \- Clinically good 3. \- Clinically sufficient 4. \- Clinically insufficient 5. \- Clinically poor

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Cengiz Yanardag

Professor

Mersin University

研究点 (2)

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