Dental Prosthesis FailureNCT04304222
Application of 3D Printed Removable Denture Prosthesis Framework for Partial Edentulous Patients
A study testing 3D Printed Denture Framework in people with Dental Prosthesis Failure, run by National Dental Centre, Singapore at 1 site in Singapore.
Trial summary
Tooth loss is a major dental problem worldwide. A recent study in Singapore found that approximately one third of adults aged over 65 are living without any natural teeth. Prevalence of loss of some teeth, or partial edentulism, in this population is estimated to be even higher. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Prosthesis Failure
- What is being tested?
- 3D Printed Denture Framework
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSingapore
- Study dates
- 26 Mar 2019to 5 Oct 2022
- 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
- Patients with partial edentulism requiring RDPs
- Above the age of 21 years
- Medically fit
- Prior denture experience
Who cannot join
- New denture wearers
- Patients with a history of maladaptation to denture use
- Patients with maxillofacial defects
Trial locations and contacts
1 site in 1 country.
About this study
Tooth loss is a major dental problem worldwide. A recent study in Singapore found that approximately one third of adults aged over 65 are living without any natural teeth. Prevalence of loss of some teeth, or partial edentulism, in this population is estimated to be even higher. Tooth loss has a series of deleterious consequences for oral and general health. The high prevalence of tooth loss has resulted in great needs and demands of prosthetic replacements, posing challenges to the public dental care system in Singapore. Removable dentures are the most widely and commonly used device to replace missing teeth and restore oral functions. The removable denture possesses a metal framework that connects other components of the denture, to ensure rigidity and stability while in function. However, the current method of fabricating denture frameworks is a complex, error-prone, time-consuming, and expensive process. Due to the inherent inaccuracies in the materials and technique, fit of the framework is compromised and undesirable to meet patients' satisfaction. With the new development of computer aided design and 3D printing metal techniques, it is now possible to apply digital design and manufacturing for the fabrication of dentures. This proposal aims to compare the precision and fit, and patient satisfaction, of 3D printed and conventional casted removable denture frameworks in preclinical and clinical settings.
Read the detailed description
Tooth loss or edentulism is a major dental problem worldwide, particularly among the senior population. A recent study in Singapore found that approximately one third of adults aged over 60 are living with complete edentulism. Prevalence of partial edentulism in this population is estimated to be even higher. The high prevalence of tooth loss has resulted in great needs and demands of prosthetic replacements, posing challenges to the public dental care system in Singapore. Removable denture prosthesis is the most commonly used device to replace missing teeth and restore oral functions. The removable denture prosthesis possesses a metal framework that connects the clasps, retainers, base and acrylic teeth, to ensure rigidity and stability while in function. However, the current way of fabricating denture frameworks using casting method is a time consuming, complex, error-prone, and expensive process. Due to the inherent inaccuracies in the materials and technique, the fit of the framework is compromised and undesirable to meet patients' satisfaction. With recent developments in computer aided design and additive manufacturing, commonly known as 3D printing or rapid prototyping, the techniques allow for printing of complex metal structures of high strength, stiffness and chemical resistance. This proposal aims to compare the precision and fit, and patient's satisfaction, of 3D printed denture frameworks and eventually translate this to a more efficient denture fabricating process.
The removable denture prosthesis is the most commonly used device to replace missing teeth and restore oral functions in patients with partial and complete edentulism. The fabrication of framework using conventional methods is time consuming and inaccurate. Thus the ultimate goal of this study is to enhance the workflow efficiency, improve the fabrication precision of the device, reduce treatment cost and time, and promote oral function and overall quality of life of patients. At the same time, the research methods developed from this study is a platform for the study of new dental devices, with potential applications for new digital dental practices. Thus, if successful, the deliverables from this research will both advance dental research, and extend applicable knowledge to the clinic.
- Conditions
- Dental Prosthesis Failure
- Being tested
- 3D Printed Denture Framework
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed Denture FrameworkDevice
The Denture Framework is 3D printed from the digital image obtained from the denture mold.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Other | To receive the conventionally made denture framework then the 3D printed denture framework. Receives: Device: 3D Printed Denture Framework |
| Sequence B | Other | To receive the 3D printed denture framework then the conventionally made denture framework. Receives: Device: 3D Printed Denture Framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the space between the occlusal rest and the corresponding rest seat among the 3D printed and conventional fabricated removable dental prosthesis (RDP) frameworks in partial edentulous patients.
The space between the occlusal rest and the corresponding rest seat in 3D printed framework is smaller than the casting framework.
Measured: End of study
Secondary outcomes (2)
To compare the patients' satisfaction towards the use of 3D printed and conventional casting RDP frameworks.
Measured: End of study
To compare the space between the occlusal rests, clasps and minor connectors of 3D printed and conventional casting RDP frameworks on patient models in the dental lab.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start26 Mar 2019
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Prosthesis FailureStudies 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
- Participants are randomized into 2 sequence: 1. To receive the conventionally made denture framework then the 3D printed denture framework 2. To receive the 3D printed denture framework then the conventionally made denture framework
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Dental Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singhealth Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304222
- Sponsor's protocol ID
- SHF/FG701S/2017
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2020
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 3D Printed Removable Denture Prosthesis Framework for Partial Edentulous Patients
- ClinicalTrials.gov ID
- NCT04304222
- Acronym / sponsor ID
- SHF/FG701S/2017
- Conditions
- Dental Prosthesis Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Dental Centre, SingaporeUniversity, hospital or other
- Collaborators
- Singhealth Foundation
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 11 Mar 2020 (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 dental problem worldwide. A recent study in Singapore found that approximately one third of adults aged over 65 are living without any natural teeth. Prevalence of loss of some teeth, or partial edentulism, in this population is estimated to be even higher. Tooth loss has a series of deleterious consequences for oral and general health. The high prevalence of tooth loss has resulted in great needs and demands of prosthetic replacements, posing challenges to the public dental care system in Singapore. Removable dentures are the most widely and commonly used device to replace missing teeth and restore oral functions. The removable denture possesses a metal framework that connects other components of the denture, to ensure rigidity and stability while in function. However, the current method of fabricating denture frameworks is a complex, error-prone, time-consuming, and expensive process. Due to the inherent inaccuracies in the materials and technique, fit of the framework is compromised and undesirable to meet patients' satisfaction. With the new development of computer aided design and 3D printing metal techniques, it is now possible to apply digital design and manufacturing for the fabrication of dentures. This proposal aims to compare the precision and fit, and patient satisfaction, of 3D printed and conventional casted removable denture frameworks in preclinical and clinical settings.
Detailed description
Tooth loss or edentulism is a major dental problem worldwide, particularly among the senior population. A recent study in Singapore found that approximately one third of adults aged over 60 are living with complete edentulism. Prevalence of partial edentulism in this population is estimated to be even higher. The high prevalence of tooth loss has resulted in great needs and demands of prosthetic replacements, posing challenges to the public dental care system in Singapore. Removable denture prosthesis is the most commonly used device to replace missing teeth and restore oral functions. The removable denture prosthesis possesses a metal framework that connects the clasps, retainers, base and acrylic teeth, to ensure rigidity and stability while in function. However, the current way of fabricating denture frameworks using casting method is a time consuming, complex, error-prone, and expensive process. Due to the inherent inaccuracies in the materials and technique, the fit of the framework is compromised and undesirable to meet patients' satisfaction. With recent developments in computer aided design and additive manufacturing, commonly known as 3D printing or rapid prototyping, the techniques allow for printing of complex metal structures of high strength, stiffness and chemical resistance. This proposal aims to compare the precision and fit, and patient's satisfaction, of 3D printed denture frameworks and eventually translate this to a more efficient denture fabricating process.
The removable denture prosthesis is the most commonly used device to replace missing teeth and restore oral functions in patients with partial and complete edentulism. The fabrication of framework using conventional methods is time consuming and inaccurate. Thus the ultimate goal of this study is to enhance the workflow efficiency, improve the fabrication precision of the device, reduce treatment cost and time, and promote oral function and overall quality of life of patients. At the same time, the research methods developed from this study is a platform for the study of new dental devices, with potential applications for new digital dental practices. Thus, if successful, the deliverables from this research will both advance dental research, and extend applicable knowledge to the clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized into 2 sequence: 1. To receive the conventionally made denture framework then the 3D printed denture framework 2. To receive the 3D printed denture framework then the conventionally made denture framework
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Other | Device: 3D Printed Denture FrameworkTo receive the conventionally made denture framework then the 3D printed denture framework. |
| Sequence B | Other | Device: 3D Printed Denture FrameworkTo receive the 3D printed denture framework then the conventionally made denture framework. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with partial edentulism requiring RDPs
- Above the age of 21 years
- Medically fit
- Prior denture experience
Key exclusion criteria (3 listed)
- New denture wearers
- Patients with a history of maladaptation to denture use
- Patients with maxillofacial defects
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 |
|---|---|---|
| 3D Printed Denture FrameworkThe Denture Framework is 3D printed from the digital image obtained from the denture mold. | Device | Sequence A, Sequence B |
Primary outcome
To compare the space between the occlusal rest and the corresponding rest seat among the 3D printed and conventional fabricated removable dental prosthesis (RDP) frameworks in partial edentulous patients.
Time frame: End of study
The space between the occlusal rest and the corresponding rest seat in 3D printed framework is smaller than the casting framework.
2 secondary outcomes
To compare the patients' satisfaction towards the use of 3D printed and conventional casting RDP frameworks.
Time frame: End of study
To compare the space between the occlusal rests, clasps and minor connectors of 3D printed and conventional casting RDP frameworks on patient models in the dental lab.
Time frame: End of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Printed Denture Framework in people with Dental Prosthesis Failure, 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 4 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: finished, as of the sponsor's last update on 5 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the space between the occlusal rest and the corresponding rest seat among the 3D printed and conventional fabricated removable dental prosthesis (RDP) frameworks in partial edentulous patients. (time frame: End of study). 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 5 Apr 2024.