Clinical Success, Oral Health-Related Quality of Life, and Relationship Between Maximum Masticatory Force and Denture Wear in Complete Dentures Fabricated by Additive Manufacturing Under Digital and Hybrid Workflows: A Prospective Randomized Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
This prospective randomized crossover clinical trial evaluates and compares the clinical performance and oral health-related quality of life (OHRQoL) of complete dentures fabricated through two additive manufacturing workflows - digital and hybrid - in edentulous patients attending the Dental Clinic of Universidad de Especialidades Espíritu Santo (UEES), Samborondón, Ecuador.
In the digital workflow, complete dentures are fabricated using direct intraoral scanning of edentulous ridges, CAD design, and 3D printing. In the hybrid workflow, conventional functional impressions are digitized, followed by CAD design and additive manufacturing of the definitive dentures.
Each eligible participant receives two complete denture sets in a randomized crossover sequence (no washout period): Denture Set 1 is worn for 2 months, after which the participant crosses over to Denture Set 2, worn for an additional 2 months. Total active follow-up per participant is approximately 4 months. Following completion of the crossover phase, denture wear is monitored longitudinally for 12 months from the insertion of the second denture set (total study duration approximately 16 months per participant).
The study addresses three specific objectives:
To determine the clinical success rate of complete dentures fabricated by additive manufacturing under digital and hybrid workflows, evaluating retention, stability, denture base adaptation, occlusal balance, and need for clinical adjustments.
To evaluate the impact of complete denture treatment on OHRQoL using the validated OHIP-EDENT questionnaire, assessed at the insertion of each denture set and at the 2-month control of each period (4 measurement points total).
To evaluate the relationship between maximum masticatory force (T-Scan digital occlusal analysis system) and denture wear (volumetric 3D digital metrology via STL superimposition), with wear monitored over 12 months from insertion of the second denture set.
详细描述
BACKGROUND Edentulism remains a significant public health concern, particularly among older adults, due to its impact on masticatory function, facial aesthetics, phonation, nutrition, and psychosocial well-being. Complete denture rehabilitation is the standard of care for edentulous patients; however, conventional fabrication techniques are associated with dimensional inaccuracies, multi-step laboratory procedures, and interoperator variability. The introduction of CAD-CAM systems and additive manufacturing (3D printing) offers potential advantages including improved precision, streamlined clinical workflows, and enhanced reproducibility. Despite growing clinical interest, robust evidence comparing digital and hybrid workflows - including patient-reported outcomes, clinical success, and objective functional measures such as masticatory force and denture wear - remains limited.
STUDY DESIGN Prospective, controlled, randomized, double-blind (participant and outcomes assessor), crossover clinical trial. No washout period between denture sets. Each participant receives two complete denture sets - one fabricated by digital workflow and one by hybrid workflow - in a randomized sequence. Total crossover phase: approximately 4 months per participant. Denture wear follow-up: 12 months from insertion of the second denture set.
PARTICIPANTS Completely edentulous adults aged 50-80 years requiring bimaxillary complete denture rehabilitation, attended at the UEES Dental Clinic. Recruitment is ongoing; first clinical appointments begin June 2026. Target sample: 28 participants (20 required for 83.7% power based on effect size d=1.25 from Peroz et al. 2024; 8 additional for anticipated dropout). Sample size calculated using G*Power 3.1, Wilcoxon-Mann-Whitney test, α=0.05, power=0.80.
INTERVENTIONS
Intervention A - Digital Workflow (3 clinical appointments):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completely edentulous (bimaxillary)
- •Age between 50 and 90 years
- •Able to understand and sign informed consent
- •No cognitive or psychological deficits that interfere with study participation
排除标准
- •Unimaxillary edentulism
- •Presence of Kelly syndrome
- •Presence of flabby tissue on alveolar ridges
- •No prior experience with complete dentures
- •Chronic motor disorders that may compromise prosthetic function
研究组 & 干预措施
digital workflow
Participants receive complete dentures fabricated by digital workflow first (intraoral scanning + CAD + 3D printing, 3 appointments), worn for 2 months, then cross over to hybrid workflow dentures for an additional 2 months.
干预措施: Digital Workflow Complete Denture (Device)
Hybrid Workflow
Participants receive complete dentures fabricated by hybrid workflow first (conventional impressions + digitization + CAD + 3D printing, 5 appointments), worn for 2 months, then cross over to digital workflow dentures for an additional 2 months.
干预措施: Hybrid Workflow Complete Denture (Device)
研究者
Pablo Lenin Benitez Sellan
Research Professor
Universidad de Especialidades Espiritu Santo