UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060241 |
|---|---|
| Receipt number | R000068900 |
| Scientific Title | Effects of Denture Base Materials on Perceived Food Hardness and Masticatory Function in Edentulous Patients: A Crossover Clinical Trial |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/31 08:43:44 |
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Basic information
Public title
The impact of different denture base materials on masticatory ease and perceived food hardness in edentulous individuals
Acronym
Perceived food hardness in complete denture wearers
Scientific Title
Effects of Denture Base Materials on Perceived Food Hardness and Masticatory Function in Edentulous Patients: A Crossover Clinical Trial
Scientific Title:Acronym
Perceived food hardness in complete denture wearers: Crossover Trial
Region
| Japan |
Condition
Condition
Edentulism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Perceived Hardness of the Test Food (100mm Visual Analog Scale)
Key secondary outcomes
masticatory performance
maximum occlusal force
Participant's preference for the denture base material
Shore A hardness of the denture base materials
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Kimoto |
Organization
Aichi Gakuin University School of Dentistry
Division name
Department of Gerodontology and Home Care Dentistry
Zip code
464-8651
Address
Department of Gerodontology and Home Care Dentistry School of Dentistry Aichi Gakuin University 2-11 Suemoritouri Chikusaku Nagoya Aichi 464-8651 Japan
TEL
+81-52-759-2154
kimoto.suguru@gmail.com
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Kimoto |
Organization
Aichi Gakuin University School of Dentistry
Division name
Department of Gerodontology and Home Care
Zip code
464-8651
Address
Department of Gerodontology and Home Care Dentistry School of Dentistry Aichi Gakuin University 2-11
TEL
+81-52-759-2154
Homepage URL
kimoto@dpc.agu.ac.jp
Sponsor or person
Institute
Aichi Gakuin University
Institute
Department
Personal name
Kimoto Suguru
Funding Source
Organization
Aichigakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Dentistry Aichi Gakuin University
Address
1-100 Kusumotocho Chikusaku Nagoya Aichi 464-8651 Japan
Tel
0527512561
kimoto.suguru@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 31 | Day |
Last modified on
| 2025 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068900
