Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060241) titled 'The impact of different denture base materials on masticatory ease and perceived food hardness in edentulous individuals' on Jan. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Aichi Gakuin University
Condition:
Condition - Edentulism
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to investigate the effects of denture base materials with different hardness on perceived food hardness, masticatory performance, and occlusal force in edentulous patients.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The purpose of this study is to investigate the effects of denture base materials with different hardness on perceived food hardness, masticatory performance, and occlusal force in edentulous patients.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Individuals who were completely edentulous in both the maxilla and mandible
Individuals who requested the fabrication of new complete dentures for the purpose of prosthetic rehabilitation
Individuals who provided written informed consent to participate in this study
Key exclusion criteria - Individuals with cognitive impairment who makes it difficult to understand verbal instructions
Individuals who were wearing a mandibular metal-base complete denture at the time of recruitment
Target Size - 24
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 25 Day
Anticipated trial start date - 2026 Year 01 Month 07 Day
Last follow-up date - 2026 Year 12 Month 25 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068900
Disclaimer: Curated by HT Syndication.
