Tokyo, Feb. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060641) titled 'Development of a Denture Extension Repair Method Using Duplicate Dentures Fabricated with an Intraoral Scanner and a 3D Printer' on Feb. 11.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Meikai University

Condition: Condition - Denture wearers requiring denture base morphology modification Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate whether a denture morphology extension repair method using duplicate dentures fabricated from scan data of the existing dentures is clinically acceptable in terms of masticatory function and patient satisfaction when compared with the fabrication of new dentures.

In patients residing in nursing care facilities or those who are unable to visit dental clinics independently, performing repairs directly on the dentures currently in use may result in pain or discomfort. Because such patients often have difficulty seeking prompt dental care, this can lead to problems or misunderstandings between patients, their families or caregivers, and dentists. To avoid these issues, a repair approach using duplicate dentures has been proposed. However, conventional fabrication of duplicate dentures requires a large amount of alginate impression material and is associated with considerable dimensional changes of the impression material, making it difficult to perform in nursing care facilities or home-visit dental settings.

Although the application of digital technologies in domiciliary dental care has attracted increasing attention, there are still limited reports in this field. Prosthodontic treatment using duplicate dentures allows the functional morphology obtained with the existing dentures to be preserved and transferred to new dentures, thereby minimizing the amount of post-insertion adjustment and potentially shortening the adaptation period. Basic objectives2 - Others

Intervention: Interventions/Control_1 - In this study, the intervention consists of scanning the existing dentures using an intraoral scanner, fabricating duplicate dentures with a 3D printer based on the scan data, and performing denture morphology extension repair using the duplicate dentures. In addition, new dentures will be fabricated, and masticatory function and patient satisfaction will be evaluated at each stage of denture use. All procedures will be performed within the scope of routine dental practice.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Patients who are able to attend the Department of Prosthodontics at Meikai University Hospital, receive routine dental care, and are using dentures determined to require denture base morphology modification. Key exclusion criteria - Individuals with severe cognitive impairment, such as advanced dementia, who have difficulty understanding the study procedures or providing informed consent

Individuals with serious systemic diseases for whom continuation of dental treatment is considered difficult

Individuals who decline to participate in the study Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 28 Day Date of IRB - 2026 Year 12 Month 01 Day Anticipated trial start date - 2026 Year 02 Month 12 Day Last follow-up date - 2030 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069355

Disclaimer: Curated by HT Syndication.