Partial-edentulismNCT06273449
A Smart Digital Workflow Towards High Precision and Through-Put Production for Removable Partial Dentures
A study testing Group 3 - 3D Printed Removable Partial Denture and Group 2 - 3D Printed Removable Partial Denture in people with Partial-edentulism, run by National Dental Centre, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Partial-edentulism
- What is being tested?
- Group 3 - 3D Printed Removable Partial Denture and Group 2 - 3D Printed Removable Partial Denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Dec 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- above the age of 21 years' old
- medically fit
- with prior denture experience
- either maxillary or mandible partial dentate
- partial edentulism with stable occlusion
Who cannot join
- History of maladaptation to denture use
- With maxillofacial or mandible bone defect(s)
- Known allergic reaction to cobalt chromium metal
Trial locations and contacts
1 site in 1 country.
Jobeth Lim Kar Yee contact
Singapore1 site, 1 recruiting
- Recruiting
National Dental Centre Singapore
Singapore, 168938
Jobeth Lim Kar Yee, jobeth.lim.kar.yee@ndcs.com.sg
Zi Ying Phang
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.
Read the 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.
- Conditions
- Partial-edentulism
- Being tested
- Group 3 - 3D Printed Removable Partial Denture, Group 2 - 3D Printed Removable Partial Denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 3 - 3D Printed Removable Partial DentureDevice
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 DentureDevice
Teeth Profile Capture Method: Physical impression RPD Design Method: Based on stone model, using design software RPD Fabrication Method: Additive manufacturing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Group 3 - 3D Printed Removable Partial Denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Assessed at the end of the study period, up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start29 Dec 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial-edentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Dental Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273449
- Sponsor's protocol ID
- 385/2023
- Status last verified
- Aug 2024
- First submitted
- 7 Nov 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smart Digital Workflow Towards High Precision and Through-Put Production for Removable Partial Dentures
- ClinicalTrials.gov ID
- NCT06273449
- Acronym / sponsor ID
- 385/2023
- Conditions
- Partial-edentulism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- National Dental Centre, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Group 2 - 3D Printed Removable Partial DenturePartial 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. |
| Group 3 | Experimental | Device: Group 3 - 3D Printed Removable Partial DentureSmartRPD 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- above the age of 21 years' old
- medically fit
- with prior denture experience
- either maxillary or mandible partial dentate
- partial edentulism with stable occlusion
Key exclusion criteria (3 listed)
- History of maladaptation to denture use
- With maxillofacial or mandible bone defect(s)
- Known allergic reaction to cobalt chromium metal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 3 - 3D Printed Removable Partial DentureTeeth Profile Capture Method: Intraoral scan RPD Design Method: Based on intraoral scan, using design software RPD Fabrication Method: Additive manufacturing | Device | Group 3 |
| Group 2 - 3D Printed Removable Partial DentureTeeth Profile Capture Method: Physical impression RPD Design Method: Based on stone model, using design software RPD Fabrication Method: Additive manufacturing | Device | Group 2 |
Primary outcome
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
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
Related trials for Partial-edentulism
Not yet recruiting
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Active, not recruiting
Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
Partial Edentulism Class 3, Removable Partial Denture
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants
Recruiting
Effect of Advanced PRF and Hyaluronic Acid on Dental Implant Healing
Partial Edentulism, Dental Implant Placement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jobeth Lim Kar Yee contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 3 - 3D Printed Removable Partial Denture and Group 2 - 3D Printed Removable Partial Denture in people with Partial-edentulism, run by National Dental Centre, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jobeth Lim Kar Yee (jobeth.lim.kar.yee@ndcs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.