Evaluation of Tooth-Supported Single-Crown Restorations Produced With Artificial Intelligence-Driven Design in a Fully Digital Workflow: A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Clinical Evaluation of Buccal and Lingual/Palatal Crown Contours
研究概览
简要总结
This clinical study compares tooth-supported single crowns designed by a dental technician and by an artificial intelligence (AI) driven automated design method. The two design methods are qualitatively compared in terms of buccal and lingual/palatal contours, proximal and occlusal contacts, and marginal fit using clinical evaluation. The two design methods are quantitatively compared in terms of global, buccal, and lingual/palatal surface deviations using three-dimensional surface deviation analysis.
详细描述
This methodological clinical study evaluates tooth-supported single crowns produced using two different digital design methods within a fully digital workflow. For each participant, two crown restorations are designed for the same prepared posterior tooth: one by an experienced dental technician using conventional computer-aided design (CAD) software and the other using an artificial intelligence (AI)-driven automated design system. Both restorations are produced using the same manufacturing workflow and are clinically evaluated under standardized conditions.
The two restorations are evaluated for buccal and lingual/palatal crown contours, mesial and distal proximal contacts, occlusal contacts, and marginal adaptation using predefined clinical criteria. In addition, three-dimensional (3D) surface deviation analysis is performed to quantitatively compare the two design methods at the global, buccal, and lingual/palatal surface levels.
The study uses a within-participant comparison design, with both design methods evaluated on the same prepared tooth, thereby minimizing variability related to patient- and tooth-specific factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
During the qualitative clinical evaluation, the investigator/outcomes assessor was blinded to the crown design method. Design identity was disclosed only for the quantitative three-dimensional surface deviation analysis to designate the reference and test datasets.
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent to participate in the study
- •Adults aged 20-39 years
- •Good general and local periodontal health with adequate oral hygiene
- •Indication for a single full-coverage crown restoration in the posterior region
- •Asymptomatic abutment tooth on clinical examination
- •No periradicular radiolucency associated with the abutment tooth on periapical radiographic examination
- •Sufficient remaining tooth structure without the need for a post-and-core restoration, allowing preservation of at least three axial walls after preparation, achievement of a ferrule with at least 1 mm of sound tooth structure coronal to the gingival level, and standardized finish-line preparation
- •Presence of intact natural teeth or restorations mesial and distal to the abutment tooth and an opposing tooth or restoration allowing establishment of occlusal contact
- •Stable interarch occlusal relationship
- •No parafunctional habits
排除标准
- •Refusal to provide written informed consent
- •Serious systemic disease or condition that may contraindicate or interfere with tooth preparation and restorative treatment, including steroid therapy, uncontrolled diabetes mellitus, immunological disorders, pregnancy, or conditions preventing adequate cooperation
- •Systemic or local risk factors that may affect the treatment process, including active periodontal disease or inadequate oral hygiene
- •History of allergy to local anesthetics containing epinephrine
- •Functional or muscular temporomandibular disorders limiting mouth opening
- •Parafunctional habits such as bruxism
研究组 & 干预措施
Within-Participant Comparison of Crown Design Methods
Each participant receives two single-crown restorations fabricated for the same prepared tooth using dental technician design and AI-driven automated design for within-participant comparison.
干预措施: Dental Technician Crown Design (Device)
Within-Participant Comparison of Crown Design Methods
Each participant receives two single-crown restorations fabricated for the same prepared tooth using dental technician design and AI-driven automated design for within-participant comparison.
干预措施: AI-Driven Automated Crown Design (Device)
结局指标
主要结局
Clinical Evaluation of Buccal and Lingual/Palatal Crown Contours
时间窗: Day 1
Dental technician-designed and AI-driven restorations are clinically evaluated for buccal and lingual/palatal crown contours using modified California Dental Association (CDA) criteria. Buccal and lingual/palatal surfaces are scored separately, and the scoring system distinguishes overcontour from undercontour.
Clinical Evaluation of Proximal Contacts
时间窗: Day 1
Dental technician-designed and AI-driven restorations are clinically evaluated for mesial and distal proximal contacts using modified California Dental Association (CDA) criteria. Mesial and distal contacts are scored separately for each restoration.
Clinical Evaluation of Occlusal Contacts
时间窗: Day 1
Dental technician-designed and AI-driven restorations are clinically evaluated for occlusal contacts using modified California Dental Association (CDA) criteria. Occlusal contacts are scored for each restoration using the predefined ordinal scoring system.
Clinical Evaluation of Marginal Adaptation
时间窗: Day 1
Dental technician-designed and AI-driven restorations are clinically evaluated for marginal adaptation using modified California Dental Association (CDA) criteria. Marginal adaptation is scored for each restoration using the predefined ordinal scoring system.
次要结局
未报告次要终点
研究者
Kıvanç Akça
Professor, Department of Prosthodontics, Faculty of Dentistry, Hacettepe University
Hacettepe University