Application of 3D Printed Removable Denture Prosthesis Framework for Partial Edentulous Patients
Primary Purpose
Dental Prosthesis Failure
Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
3D Printed Denture Framework
Sponsored by
About this trial
This is an interventional supportive care trial for Dental Prosthesis Failure
Eligibility Criteria
Inclusion Criteria:
- Patients with partial edentulism requiring RDPs
- Above the age of 21 years
- Medically fit
- Prior denture experience
Exclusion Criteria:
- New denture wearers
- Patients with a history of maladaptation to denture use
- Patients with maxillofacial defects
Sites / Locations
- National Dental Centre Singapore
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Sequence A
Sequence B
Arm Description
To receive the conventionally made denture framework then the 3D printed denture framework.
To receive the 3D printed denture framework then the conventionally made denture framework.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To compare the patients' satisfaction towards the use of 3D printed and conventional casting RDP frameworks.
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.
Full Information
NCT ID
NCT04304222
First Posted
March 9, 2020
Last Updated
March 9, 2020
Sponsor
National Dental Centre, Singapore
Collaborators
Singhealth Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04304222
Brief Title
Application of 3D Printed Removable Denture Prosthesis Framework for Partial Edentulous Patients
Official Title
Application of 3D Printed Removable Denture Prosthesis Framework for Partial Edentulous Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Dental Centre, Singapore
Collaborators
Singhealth Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Prosthesis Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Participants are randomized into 2 sequence:
To receive the conventionally made denture framework then the 3D printed denture framework
To receive the 3D printed denture framework then the conventionally made denture framework
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
2 study team clinicians are the designated care providers to the participants hence they are masked together with the participants. One of the masked clinicians is the Principal investigator.
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence A
Arm Type
Other
Arm Description
To receive the conventionally made denture framework then the 3D printed denture framework.
Arm Title
Sequence B
Arm Type
Other
Arm Description
To receive the 3D printed denture framework then the conventionally made denture framework.
Intervention Type
Device
Intervention Name(s)
3D Printed Denture Framework
Intervention Description
The Denture Framework is 3D printed from the digital image obtained from the denture mold.
Primary Outcome Measure Information:
Title
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.
Description
The space between the occlusal rest and the corresponding rest seat in 3D printed framework is smaller than the casting framework.
Time Frame
End of study
Secondary Outcome Measure Information:
Title
To compare the patients' satisfaction towards the use of 3D printed and conventional casting RDP frameworks.
Time Frame
End of study
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with partial edentulism requiring RDPs
Above the age of 21 years
Medically fit
Prior denture experience
Exclusion Criteria:
New denture wearers
Patients with a history of maladaptation to denture use
Patients with maxillofacial defects
Facility Information:
Facility Name
National Dental Centre Singapore
City
Singapore
ZIP/Postal Code
168938
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Application of 3D Printed Removable Denture Prosthesis Framework for Partial Edentulous Patients
We'll reach out to this number within 24 hrs