UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060623 |
|---|---|
| Receipt number | R000069338 |
| Scientific Title | The Effect of Continuous Management of Dental Caries and Periodontal Disease on Oral Function and Nutritional Status in Middle-aged and Elderly People |
| Date of disclosure of the study information | 2026/02/10 |
| Last modified on | 2026/02/09 13:15:33 |
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Basic information
Public title
The Effect of Continuous Management of Dental Caries and Periodontal Disease on Oral Function and Nutritional Status in Middle-aged and Elderly People
Acronym
The Eat Well, Live Well Study
Scientific Title
The Effect of Continuous Management of Dental Caries and Periodontal Disease on Oral Function and Nutritional Status in Middle-aged and Elderly People
Scientific Title:Acronym
COMANS Study Continuous Oral MAnagement and Nutritional Status Study
Region
| Japan |
Condition
Condition
Oral frailty, Periodontal disease. Dental caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to scientifically elucidate the potential preventive effects of supportive periodontal therapy (SPT) on oral frailty by examining its impact on overall oral function and nutritional status through a combined cross-sectional and retrospective cohort analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between periodontal inflammatory status (PISA value) and oral function, particularly maximum tongue pressure
Key secondary outcomes
Association between periodontal inflammatory status (PISA value) and nutritional status (nutrient intake assessed by BDHQ)
Association between periodontal inflammatory status and other oral functional parameters (bite force, masticatory performance, tongue-lip motor function, and swallowing function)
Association between past SPT attendance (duration and intervals) and current oral functional parameters as well as periodontal inflammatory status
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
| 50 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who have provided written informed consent.
Aged between 50 and 79 years.
Have been receiving supportive periodontal therapy (SPT) at the participating dental clinic for at least one year.
Currently possess 20 or more natural teeth.
Key exclusion criteria
Individuals with acute inflammatory symptoms in the oral cavity
Individuals with a gelatin allergy
Individuals with severe systemic diseases or poorly controlled diabetes mellitus
Individuals diagnosed with dementia or whose capacity to provide informed consent is in doubt
Any other individuals deemed unsuitable by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Kurita |
Organization
Lion Foundation for Dental Health
Division name
Department of Research
Zip code
111-8644
Address
1-3-28 Kuramae, Taito-ku, Tokyo , Japan
TEL
+81-3-6739-9000
kei-k@lion.co.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Ishihara |
Organization
The Lion Foundation for Dental Health
Division name
Department of Research
Zip code
111-8644
Address
1-3-28 Kuramae, Taito-ku, Tokyo , Japan
TEL
0367399000
Homepage URL
ishihayu@lion.co.jp
Sponsor or person
Institute
The Lion Foundation for Dental Health
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C) from the Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (IRB) of The Lion Foundation for Dental Health
Address
1-3-28 Kuramae, Taito-ku, Tokyo , Japan
Tel
0367399000
ayae-mg@lion.co.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 | 10 | 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
| 2026 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preparing for ethics committee submission
Management information
Registered date
| 2026 | Year | 02 | Month | 09 | Day |
Last modified on
| 2026 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069338
