Application of 3D Printed Removable Denture Prosthesis Framework for Partial Edentulous Patients

NCT ID: NCT04304222

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-26
• Study Completion Date: 2022-10-05

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.

Conditions

Dental Prosthesis Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Sequence A

To receive the conventionally made denture framework then the 3D printed denture framework.

Group Type: OTHER

3D Printed Denture Framework

Intervention Type: DEVICE

The Denture Framework is 3D printed from the digital image obtained from the denture mold.

Sequence B

To receive the 3D printed denture framework then the conventionally made denture framework.

Group Type: OTHER

3D Printed Denture Framework

Intervention Type: DEVICE

The Denture Framework is 3D printed from the digital image obtained from the denture mold.

Interventions

3D Printed Denture Framework

The Denture Framework is 3D printed from the digital image obtained from the denture mold.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Singhealth Foundation

OTHER_GOV

Sponsor Role: collaborator

National Dental Centre, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Dental Centre Singapore

Singapore, , Singapore

Countries

Singapore

Other Identifiers

SHF/FG701S/2017

Identifier Type: -

Identifier Source: org_study_id