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

NCT06273449 | Recruiting

• 1 other identifier: 385/2023
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Partial-edentulism

Outcome Measures

Primary Outcomes (3)

• 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

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

• 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.

  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

  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.

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

Study Arms (3)

Group 1

NO INTERVENTION

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

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.

Device: Group 2 - 3D Printed Removable Partial Denture

Group 3

EXPERIMENTAL

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.

Device: Group 3 - 3D Printed Removable Partial Denture

Interventions

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 3

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

Group 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Dental Centre, Singapore: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

National Dental Centre Singapore

Singapore, 168938, Singapore

RECRUITING

Central Study Contacts

Jobeth Lim Kar Yee

CONTACT

jobeth.lim.kar.yee@ndcs.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Conventional: The Standard of Care (SOC) workflow, which will act as a baseline compared to the other 2 groups. 2. Partial digital workflow: 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, instead of using lost wax casting, the digital design is used for additive manufacturing. 3. SmartRPD digital workflow 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 but on the digital model instead, the design of RPD is digitally performed. The digital design is used for additive manufacturing.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: February 22, 2024
• Study Start: December 29, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

SG (1)