UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057954 |
|---|---|
| Receipt number | R000066258 |
| Scientific Title | A Cross-Sectional Study on the Validity and Utility of a Cognitive Decline Screening Method in Dental Outpatients |
| Date of disclosure of the study information | 2025/05/23 |
| Last modified on | 2025/11/22 10:29:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of a Screening Method for Cognitive Decline in Dental Outpatient Clinics
Acronym
Dental Screening Study
Scientific Title
A Cross-Sectional Study on the Validity and Utility of a Cognitive Decline Screening Method in Dental Outpatients
Scientific Title:Acronym
Cognitive Screening Validity Study
Region
| Japan |
Condition
Condition
Cognitive Decline
Classification by specialty
| Neurology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop a novel screening method for cognitive decline based on oral function and gustatory perception among dental outpatients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive decline (as assessed by the Japanese version of the Montreal Cognitive Assessment [MoCA-J])
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Older adults aged 65 years or older
Key exclusion criteria
1) Patients certified as requiring long-term care
2) Patients diagnosed with or undergoing treatment for dementia, cancer, or psychiatric disorders, such as depression and schizophrenia
3) Patients with brain abnormalities detected by magnetic resonance imaging (MRI)
4) Patients with severe xerostomia, chronic otitis media, or sinusitis
5) Patients with a complete denture covering the palate
Target sample size
57
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Mizutani |
Organization
Kyushu University
Division name
OBT Center, Faculty of Dental Science
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
0926426485
mizutani@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Mizutani |
Organization
Kyushu University
Division name
OBT Center, Faculty of Dental Science
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
0926426485
Homepage URL
mizutani@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics Review Office, Research Support Section, Department of Administrative Affairs, Kyushu University Hospital
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
Tel
092-642-5082
irbhoukoku@jimu.kyushu-u.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
| 2025 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
58
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2025 | Year | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066258
