Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04304222 |
| Other study ID # |
SHF/FG701S/2017 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 26, 2019 |
| Est. completion date |
October 5, 2022 |
Study information
| Verified date |
April 2024 |
| Source |
National Dental Centre, Singapore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
