About this trial
Tooth loss is a major chronic problem in dentistry and edentulous elderly endures poorer quality of life worldwide. Removable partial dentures (RPDs) are the most widely accepted and cost-effective treatment for patients to restore oral functions. RPDs contain three components including the metal framework, denture base and acrylic teeth. Conventionally, RPD fabrication involves tedious clinical and dental laboratory procedures and is time consuming, labour-intensive, and often imprecise, therefore incapable of meeting the growing demands of RPD by an ageing population. The challenges to achieve a high quality and high-throughput RPD service lie in three aspects: 1) accuracy in capturing oral profile; 2) immediate oral information analysis and device design, and 3) automation in production.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
above the age of 21 years' old
medically fit
with prior denture experience
either maxillary or mandible partial dentate
Disqualifiers
History of maladaptation to denture use
With maxillofacial or mandible bone defect(s)
Known allergic reaction to cobalt chromium metal
Trial design
Sequential
Treatments tested in this trial
Group 3 - 3D Printed Removable Partial Denture
DeviceTeeth Profile Capture Method: Intraoral scan RPD Design Method: Based on intraoral scan, using design software RPD Fabrication Method: Additive manufacturing
Group 2 - 3D Printed Removable Partial Denture
DeviceTeeth Profile Capture Method: Physical impression RPD Design Method: Based on stone model, using design software RPD Fabrication Method: Additive manufacturing
Treatment groups
Trial outcomes
Primary outcomes
Evaluation of Precision in Fabricated Metal Frameworks Across Three Workflows
The precision of fabricated RPD metal frameworks will be assessed by measuring the gaps between occlusal rests and corresponding rest seats of abutment teeth during the clinical try-in stage. Clinical parameters including support, retention, and stability will be evaluated by calibrated clinical evaluators to compare framework quality among three patient groups. Measurement: Gap measurements between occlusal rest and corresponding rest seat
Comparison of Patient Satisfaction with RPD Prostheses Fabricated Using Three Workflows
Patient satisfaction with final RPD prostheses will be compared among three workflows. Assessment of patient satisfaction with various oral functions will be conducted using validated denture and oral health impact (OHIP) questionnaires. Measurement: Patient-reported satisfaction scores on denture and oral health impact questionnaires.
Comparison of Fabrication Cost and Time Across Three Workflows
he study aims to compare fabrication cost and time spent on three workflows. Direct and indirect costs, clinical chair time, and laboratory work time will be measured based on an operational model in a dental clinic. Additionally, exploratory analysis will be conducted to assess changes in quality-adjusted life years attributable to different dental workflows. Measurement: Direct and indirect costs, clinical chair time, laboratory work time, and potential changes in quality-adjusted life years.
Sponsors and contacts
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National Dental Centre, Singapore
Lead sponsor
National Medical Research Council (NMRC), Singapore
Collaborator