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

National Dental Centre, Singapore

Status: Enrolling

Conditions: Partial-edentulism

Treatments: Device: Group 3 - 3D Printed Removable Partial Denture; Device: Group 2 - 3D Printed Removable Partial Denture

Study type: Interventional

Funder types: Other

Identifiers

NCT06273449

385/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 141 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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141 participants in 3 patient groups

Group 1

No Intervention group

Description:

Conventional: The Standard of Care (SOC) workflow, which will act as a baseline compared to the other 2 groups. Teeth Profile Capture Method: Physical impression RPD Design Method: Based on stone model, using wax pattern RPD Fabrication Method: Lost wax casting

Group 2

Experimental group

Description:

Partial Digital: Similar to the SOC, Group 2 adopts the same teeth profile capture method, where a physical impression of teeth profile is taken from the subject. However, instead of using physical wax pattern on the stone model for design, the stone model is scanned and, on the scan, the design is performed digitally. For fabrication of RPD in Group 2, instead of using lost wax casting as per the SOC, the digital design is used for additive manufacturing.

Treatment:

Device: Group 2 - 3D Printed Removable Partial Denture

Group 3

Experimental group

Description:

SmartRPD Digital: Group 3 adopts a different teeth profile capture method by using the intraoral scanner to digitally scan and save the subject's teeth profile. From the intraoral scan, a digital model of the subject's teeth profile is created. Similar to Group 2, but on the digital model instead, the design of RPD is digitally performed. The digital design, as per Group 2, is used for additive manufacturing.

Treatment:

Device: Group 3 - 3D Printed Removable Partial Denture