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

Partial-edentulism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273449
• Other study ID #: 385/2023
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2024
• Source: National Dental Centre, Singapore
• Contact: Hazel Goh Si Ying
• Phone: 63248754
• Email: goh.si.ying[@]ndcs.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 141
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Partial-edentulism

Intervention

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
• 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

Locations

Country	Name	City	State
Singapore	National Dental Centre Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National Dental Centre, Singapore	National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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