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

NCT04304222 | Completed

• 1 other identifier: SHF/FG701S/2017
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Prosthesis Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  End of study

Secondary Outcomes (2)

• To compare the patients' satisfaction towards the use of 3D printed and conventional casting RDP frameworks.

  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.

  End of study

Study Arms (2)

Sequence A

OTHER

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

Device: 3D Printed Denture Framework

Sequence B

OTHER

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

Device: 3D Printed Denture Framework

Interventions

3D Printed Denture Framework DEVICE

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

Sequence A; Sequence B

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with partial edentulism requiring RDPs
• Above the age of 21 years
• Medically fit
• Prior denture experience

You may not qualify if:

• New denture wearers
• Patients with a history of maladaptation to denture use
• Patients with maxillofacial defects

Sponsors & Collaborators

• National Dental Centre, Singapore: lead
• Singhealth Foundation: collaborator

Study Sites (1)

National Dental Centre Singapore

Singapore, 168938, Singapore

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: March 26, 2019
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)