Tokyo, April 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061365) titled 'Evaluation of the clinical effectiveness of digital dentures produced by 3D printers' on April 23.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kanagawa Dental University
Condition:
Condition - Edentulous upper and lower jaws
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The clinical effectiveness of digitally manufactured dentures produced using a 3D printer will be compared and evaluated with that of dentures produced using conventional methods. (Satisfaction evaluation, masticatory function evaluation, occlusal force, contact area, time study, and cost evaluation)
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Patients with edentulous upper and lower jaws who visited Kanagawa Dental University Hospital requesting complete dentures
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients with edentulous upper and lower jaws who visited Kanagawa Dental University Hospital requesting complete dentures
Key exclusion criteria - 1. Patients with physical or mental issues
2. Patients who cannot understand or read Japanese
3. Patients with dementia or other conditions that make it difficult for them to cooperate with questionnaire evaluations
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 31 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067262
Disclaimer: Curated by HT Syndication.
