UMIN-CTR Clinical Trial

Basic information
Public title	Study of the relationship between oral function and cognitive decline in elderly people
Acronym	Study of the relationship between oral function and cognitive decline
Scientific Title	Study of the relationship between oral function and cognitive decline in elderly people
Scientific Title:Acronym	Study of the relationship between oral function and cognitive decline
Region	Japan

Condition
Condition	Elderly person including mild cognitive impairment (MCI) individual
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of the change of oral function on the cognitive decline in elderly people including mild cognitive impairment(MCI) individual
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the change of MCI biomarkers during 2 year
Key secondary outcomes	oral function, oral state

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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) the patients who participated in research theme "Examination of relationship between oral function and cognitive decline in mild cognitive impairment elderly people with mild cognitive impairment"(Fukuoka Gakuen permission number No. 329) (2) written informed consent provided for study participation (3)the outpatient of Geriatric Dentistry in Fukuoka Dental College Hospital (4) 65 years-old <= (5) normal cognitive function and MCI
Key exclusion criteria	(1) patient with dementia (2) others whom the principal investigator decides to exclude
Target sample size	54

Research contact person
Name of lead principal investigator	1st name Shinsuke Middle name Last name Mizutani
Organization	Kyushu University
Division name	Section of Geriatric Dentistry and Perioperative Medicine in Dentistry, Division of Maxillofacial Diagnostic and Surgical Sciences Faculty of Dental Science
Zip code	812-8582
Address	3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan.
TEL	092-642-6485
Email	mizutani@dent.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Shinsuke Middle name Last name Shinsuke
Organization	Kyushu University
Division name	Section of Geriatric Dentistry and Perioperative Medicine in Dentistry, Division of Maxillofacial Di
Zip code	812-8582
Address	3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan.
TEL	092-642-6485
Homepage URL
Email	mizutani@dent.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

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	Fukuoka dental college
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyushu University
Address	3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan.
Tel	092-642-5774
Email	ijkseimei@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	2018 Year 07 Month 13 Day

Related information
URL releasing protocol	https://onlinelibrary.wiley.com/doi/10.1111/joor.13224
Publication of results	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/10.1111/joor.13224
Number of participants that the trial has enrolled	54
Results	The follow-up rate in this study was 67%. The masticatory performance was improved (P<0.001), whereas gingival inflammation was decreased (P < 0.001) over the 2-year period. A significant increase in the MMSE score (P <0.001) and a decrease in MCI risk (P<0.001) were noted. The decrease in MCI risk was correlated with the increase in both masticatory performance (P<0.05) and MMSE score (P<0.01).
Results date posted	2021 Year 07 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 07 Month 09 Day
Baseline Characteristics	See the journal publication of results
Participant flow	See the journal publication of results
Adverse events	No
Outcome measures	MCI risk
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 07 Month 04 Day
Date of IRB	2018 Year 07 Month 04 Day
Anticipated trial start date	2018 Year 07 Month 04 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 07 Month 14 Day

Other
Other related information	observational study study design: cohort study

Management information
Registered date	2018 Year 07 Month 13 Day
Last modified on	2021 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038059