A Randomized, Double-Blind, Three-Arm Superiority Trial Comparing Occlusal Wear of 3D-Printed, CAD/CAM-Milled, and Prefabricated Denture Teeth in Digitally Fabricated Complete Dentures in Edentulous Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
研究概览
简要总结
This randomized controlled trial evaluates the occlusal wear of denture teeth fabricated using three digital workflows: 3D-printed denture teeth, CAD/CAM-milled double cross-linked denture teeth, and prefabricated denture teeth. Occlusal wear will be assessed over 24 months using digital superimposition techniques. The study aims to determine whether 3D-printed denture teeth demonstrate superior wear resistance compared to CAD/CAM-milled denture teeth.
详细描述
This is a single-center, prospective, randomized, controlled, double-blind clinical investigation comparing three digitally fabricated complete removable dental prosthesis workflows in edentulous patients. The study will be conducted at the University Clinics of Dental Medicine, University of Geneva.
The study includes adult patients who are completely edentulous in the maxillary and mandibular arches and require new complete removable dental prostheses. Participants may be rehabilitated with either a conventional mandibular complete denture or a mandibular implant overdenture supported by clinically stable implants. This inclusion strategy is intended to improve recruitment feasibility and reflect real-world clinical practice. Mandibular prosthetic status at baseline will be used as a stratification factor during randomization and will be accounted for in the statistical analysis.
A total of 48 participants** will be randomized in a 1:1:1 allocation ratio to one of three treatment groups: fully 3D-printed complete dentures with printed denture base and printed denture teeth; CAD/CAM-milled complete dentures with milled double cross-linked denture teeth; or CAD/CAM-milled complete dentures with prefabricated denture teeth, serving as a clinical benchmark group.
The primary objective is to compare occlusal wear performance of denture teeth between the fabrication workflows. The primary confirmatory comparison will be conducted between the fully 3D-printed workflow and the CAD/CAM-milled double cross-linked workflow. Occlusal wear will be assessed by three-dimensional digital superimposition of intraoral scans acquired at baseline and follow-up visits. The primary endpoint is the average negative deviation of occlusal surfaces at 24 months, representing material loss over time.
> Secondary outcomes include root mean square surface deviation, patient-reported outcomes assessed with the Oral Health Impact Profile for Edentulous Patients and the Denture Satisfaction Index, chewing efficiency, bite force, prosthetic retention, color stability, prosthesis-related costs, maintenance interventions, and prosthetic complications. These outcomes will be assessed according to the study schedule at baseline and during follow-up visits at 12, 24, and 60 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This study is double-blind. Participants and outcome assessors are blinded to the allocation of denture tooth material. All prostheses are fabricated externally and labeled using anonymized codes to conceal the fabrication method aand type of denture teeth used. The external appearance of the prostheses is standardized to prevent identification of the material. Digital files used for outcome assessment (wear analysis) are anonymized and coded by study ID and timepoint, ensuring that outcome assessors remain blinded throughout the analysis.
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
- •Written informed consent provided by the participant
- •Age ≥ 18 years
- •Fully edentulous maxilla and mandible requiring rehabilitation with new complete removable dental prostheses
- •Patients with or without mandibular implants (implant overdenture or conventional denture)
- •Clinical indication for fabrication of new maxillary and mandibular complete removable dental prostheses
- •Currently wearing complete dentures, or a maxillary denture combined with a mandibular denture or overdenture
- •Ability and willingness to attend all scheduled follow-up visits for the duration of the study
排除标准
- •Contraindications to the medical devices used, e.g. known hypersensitivity or allergy;
- •Known or suspected non-compliance, drug or alcohol abuse; Inability to follow the procedures of the investigation;
- •Enrolment of the investigator, his/her family members, employees and other dependent persons;
- •Reported severe bruxism or clenching habits, identified through patient interview and clinical examination, including self-reported grinding or clenching, partner reports, morning jaw discomfort, and other signs of parafunctional activity;
- •Width of the edentulous maxilla >80 mm;
- •Width of the edentulous mandible >80 mm; Vertical prosthetic space <38 mm (maxilla or mandible);
- •Depression: Geriatric Depression Scale >9;
- •Xerostomia: UFR ≤ 0.2ml/2min;
- •Dementia: Clock-Drawing Test ≤5;
- •Active peri-implant disease or instability of the two mandibular implants at baseline when implants are present;
- •Presence of an implant-retained prosthesis in the maxilla;
- •Planned implant-related surgical intervention during the study period.
研究者
Najla Chebib
PD Dr
University of Geneva, Switzerland