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NCT Number: NCT06273449

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

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.

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Key information

Conditions

Partial-edentulism

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Dental Centre Singapore

Singapore, 168938

Location status: Recruiting

Location contact

Janice Tan Zhi Hui

SUB_INVESTIGATOR

Jobeth Lim Kar Yee

CONTACT

[email protected]

Zi Ying Phang

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Evaluation of Precision in Fabricated Metal Frameworks Across Three Workflows

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

    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

  2. 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

    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.

  3. Comparison of Fabrication Cost and Time Across Three Workflows

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jobeth Lim Kar Yee

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

National Dental Centre, Singapore

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 22, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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