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Recruiting NCT06273449

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

No phase Interventional Partial-edentulism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group 3 - 3D Printed Removable Partial Denture, Group 2 - 3D Printed Removable Partial Denture.
Who it may be relevant to
Registry conditions: Partial-edentulism. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Towards this goal, we have developed an intelligent RPD design software prototype, SmartRPD, to generate RPD metal framework design using digital scans from patients. SmartRPD processes patient-specific scanned geometry instantly, provide diagnosis analysis and generate the first draft of metal framework design automatically, powered by a teeth geometry segmentation system, knowledge-based design algorithm and 3D geometry engines. Dentists make the final clinical changes and confirmation before sending the 3D digital files for 3D printing. Thereafter, an altered digital scan technique is used to register a precise digital scan of soft tissues under functioning, using the metal framework as a loading impression tray and digitally align to the initial oral scan. This resulted modified master scan file leads to a more accurate setting for the denture base in the subsequent procedures.

Interventions

  • Device Group 3 - 3D Printed Removable Partial Denture
    Teeth Profile Capture Method: Intraoral scan RPD Design Method: Based on intraoral scan, using design software RPD Fabrication Method: Additive manufacturing
  • Device Group 2 - 3D Printed Removable Partial Denture
    Teeth Profile Capture Method: Physical impression RPD Design Method: Based on stone model, using design software RPD Fabrication Method: Additive manufacturing

Primary outcome measures

  • Evaluation of Precision in Fabricated Metal Frameworks Across Three Workflows [Time frame: Assessed at the end of the study period, up to 14 months]
  • Comparison of Patient Satisfaction with RPD Prostheses Fabricated Using Three Workflows [Time frame: From date of randomization during first visit till 3rd follow up visit, assessed up to 14 months]
  • Comparison of Fabrication Cost and Time Across Three Workflows [Time frame: Assessed at the end of the study period, up to 14 months]

Eligibility criteria

Inclusion criteria

  • above the age of 21 years' old
  • medically fit
  • with prior denture experience
  • either maxillary or mandible partial dentate
  • partial edentulism with stable occlusion

Exclusion criteria

  • History of maladaptation to denture use
  • With maxillofacial or mandible bone defect(s)
  • Known allergic reaction to cobalt chromium metal

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Supportive care

Study locations

Singapore · 1 center
  • National Dental Centre Singapore — Singapore

Identifiers

NCT: NCT06273449 · 385/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗