Clinical trial NCT06273449: A Smart Digital Workflow Towards High Precision and Through-Put Production for Removable Partial Dentures
Official title: A Smart Digital Workflow Towards High Precision and Through-Put Production for Removable Partial Dentures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Partial-edentulism
Lead sponsor: National Dental Centre, Singapore
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
First posted: 2024-02-22
Enrollment: 141
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Evaluation of Precision in Fabricated Metal Frameworks Across Three Workflows
timeFrame: Assessed at the end of the study period, up to 14 months
measure: Comparison of Patient Satisfaction with RPD Prostheses Fabricated Using Three Workflows
timeFrame: From date of randomization during first visit till 3rd follow up visit, assessed up to 14 months
measure: Comparison of Fabrication Cost and Time Across Three Workflows
timeFrame: Assessed at the end of the study period, up to 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Dental Centre Singapore
Study officials:
References: