UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059452 |
|---|---|
| Receipt number | R000067994 |
| Scientific Title | Can implant prostheses improve cognitive function in older adults? |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2025/10/18 14:58:10 |
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Basic information
Public title
Can implant prostheses improve cognitive function in older adults?
Acronym
Implant prostheses and cognitive function in older adults
Scientific Title
Can implant prostheses improve cognitive function in older adults?
Scientific Title:Acronym
Implant prostheses and cognitive function in older adults
Region
| Japan |
Condition
Condition
parcial/complete edentulouness
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether there is a difference in the effects on cognitive function between wearing implant prostheses and wearing removable dentures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MoCA-J
Key secondary outcomes
cognitive functional assessment
energy, nutritional, and food intakes
masticatory function
oral health related quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To fabricate and set a fixed implant prosthesis or a removable implant prosthesis (IOD, implant-supported removable partial denture (IARPD)) for the missing teeth area, performing adjustments as needed.
Interventions/Control_2
To fabricate and set a complete denture or a partial denture for the missing teeth area, performing adjustments as needed
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Aged 65 or older
Individuals who have lost occlusal support
Individuals who plan to restore the edentulous area with fixed implant prostheses, removable implant prostheses, or removable dentures, or for whom such restoration has been decided
Key exclusion criteria
Individuals with poorly controlled systemic diseases
History of BP medication use
History of chemotherapy or radiation therapy to the head and neck
Heavy smokers (10 or more cigarettes per day)
Infectious diseases
Mental disorders
Temporomandibular joint disorders
Other individuals deemed ineligible by the principal investigator or co-investigators
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Yuriko |
| Middle name | |
| Last name | Komagamine |
Organization
Institute of Science Tokyo
Division name
Gerodontology and Oral Rehabilitation
Zip code
113-8549
Address
1-5-45, Yurshima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4645
y.komagamine.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Komagamine |
Organization
Institute of Science Tokyo
Division name
Gerodontology and Oral Rehabilitation
Zip code
113-8549
Address
1-5-45, Yurshima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4645
Homepage URL
y.komagamine.gerd@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Yuriko Komagamine
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Promotion Division, Research Infrastructure Promotion Section Bioethics Group, Institute of Science Tokjyo
Address
1-5-45, Yurshima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-4645
y.komagamine.gerd@tmd.ac.jp
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 | 02 | 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 | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | 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 | 10 | Month | 18 | Day |
Last modified on
| 2025 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067994
