A Smart Digital Workflow Towards High Precision and Through-Put Production for Removable Partial Dentures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorNational Dental Centre, Singapore

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Group 3 - 3D Printed Removable Partial Denture

    Device

    Teeth 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

    Device

    Teeth Profile Capture Method: Physical impression RPD Design Method: Based on stone model, using design software RPD Fabrication Method: Additive manufacturing

Treatment groups

141 Participants
are divided into 3 treatment groups
Group A: Group 1No intervention 0 interventions
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Assessed at the end of the study period, up to 14 months
2

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.

Time frame
From date of randomization during first visit till 3rd follow up visit, assessed up to 14 months
3

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.

Time frame
Assessed at the end of the study period, up to 14 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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National Dental Centre, Singapore

Lead sponsor

National Medical Research Council (NMRC), Singapore

Collaborator