UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043323 |
|---|---|
| Receipt number | R000048199 |
| Scientific Title | Intervention study for prevention of oral frailty |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2024/02/27 12:34:34 |
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Basic information
Public title
Development and assessment of home-based oral health model for prevention of oral frailty
Acronym
Establishment of database and preventive model for oral frailty
Scientific Title
Intervention study for prevention of oral frailty
Scientific Title:Acronym
Intervention for oral frailty
Region
| Japan |
Condition
Condition
oral hypofunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prevention for oral frailty
Basic objectives2
Others
Basic objectives -Others
Frailty and sarcopenia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral function, systemic health condition, and nutritional status
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Oral care
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 | months-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Category 1 of needing carer
Key exclusion criteria
Individuals with no needing for care
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Ansai |
Organization
Kyushu Dental Univ.
Division name
Div. Community Oral Health Development
Zip code
8038580
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu
TEL
0932853089
r06ansai@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Kakuta |
Organization
Kyushu Dental Univ.
Division name
Div. Community Oral Health Development
Zip code
8038580
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu
TEL
0932853089
Homepage URL
r06ansai@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental Univ.
Institute
Department
Personal name
Funding Source
Organization
Buzen City
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu Dental Univ.
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu
Tel
0932853011
kyoumu@kyu-dent.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
| 2021 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
218
Results
Oral function was evaluated using ROAG, which consists of voice, swallowing, lips, teeth and dentures, mucosa, gingiva, tongue, and saliva. A smaller total score for the 8 items indicates better oral function. For the analysis, a score of 8 or less indicated good oral function, and a score of 9 or more indicated poor oral function. The results showed that the group with good oral function had a good level of independence in daily living and cognitive independence.
Results date posted
| 2024 | Year | 02 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
Participant flow
At the initial visit, oral examination, blood test, nutritional survey (BDHQ, 10-meal item checker), etc. by dentists (Buzen-Tikujyo Dental Association and Kyushu Dental University), dietitian, dental hygienist, etc. will be conducted and evaluated. After the initial visit, the dental hygienist will instruct the patient on daily tooth brushing and oral exercises such as "Aiube exercises" and provide oral care. After approximately 3 months of guidance visits, the same examination as the initial visit is conducted, and the results of the investigation are explained in detail at a later date.
Adverse events
There is no report.
Outcome measures
Assessments were conducted based on the Oral Health Examination Form. Assessments at the initial and final visits included an oral examination, tongue pressure test, and oral bacteria test. Nutritional status was assessed using the BDHQ questionnaire and a 10-item checker. The BDHQ was analyzed by Gender Medical Research, Inc. in a manner that protected personal information. In addition, detailed analysis of body composition using the InBody body composition analyzer and measurement of lifestyle-related disease items using the DEMECAL blood test kit (Ledger) were also conducted. In addition, as clinical examinations, participants' height, weight, grip strength, and calf circumference were measured, and their oral frailty was assessed using a simple nutritional status evaluation chart and the Functional Oral Intake Scale (FOIS), which evaluates the oral intake status of food.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048199
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/02/22 | 豊前市在宅歯科訪問事業実施報告書_2020.pdf |
