UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048624 |
|---|---|
| Receipt number | R000055402 |
| Scientific Title | Study of standard care guidelines for the tongue coating |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2024/02/09 11:29:08 |
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Basic information
Public title
Study of tongue care methods
Acronym
Study of tongue care methods
Scientific Title
Study of standard care guidelines for the tongue coating
Scientific Title:Acronym
Study of standard care guidelines for the tongue coating
Region
| Japan |
Condition
Condition
Tongue coating
Classification by specialty
| Dental medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop guidelines for standard oral care for tongue coating by examining the relationship between the tongue care instruments, scrubbing pressure, and number of scrubbings and bleeding test.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of scrubbings of the tongue
Key secondary outcomes
Scrubbing pressure on the tongue
Bleeding test
Tongue care instruments
Moisture of the oral mucosa
etc
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
We care for the tongue mucosa at the prescribed scrubbing pressure and prescribed number of scrubbings, and measure the bleeding test.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The Healthy adults between 18 and 65 years old
2. The healthy elderly who aged 65 and over
3. The elderly who staying in nursing homes
Key exclusion criteria
1. Having oral mucosa disease
2. Having salivary gland disease
3. Received intraoral radiation therapy at any time in the past
4. The elderly who cannot cooperate with oral care
5. Smoker
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Tada |
Organization
Kyusyu Dental University
Division name
Division of Special Needs and Geriatric Dentistry
Zip code
803-8580
Address
2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka 803-8580, Japan
TEL
093-582-1131
r07sakakibara@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Tada |
Organization
Kyusyu Dental University
Division name
Division of Special Needs and Geriatric Dentistry
Zip code
803-8580
Address
2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka 803-8580, Japan
TEL
093-582-1131
Homepage URL
r07sakakibara@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Division of Special Needs and Geriatric Dentistry, Kyusyu Dental University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
Kyushu Dental College Ethics Committee
Address
2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka 803-8580, Japan
Tel
093-582-113
r07sakakibara@fa.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
九州歯科大学附属病院（福岡県）、シルバーサンホーム（福岡県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | 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
It was difficult to evaluate microbleeding on the back of the tongue before and after tongue cleaning because the occult blood reaction was confirmed only by gargling, even in healthy young subjects without gingivitis findings. As for the method of collecting samples by pouring saliva on the tongue into a container with water, it was considered possible to evaluate microbleeding on the tongue mucosa because the occult blood reaction was confirmed after tongue cleaning.
Results date posted
| 2024 | Year | 02 | Month | 09 | Day |
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 08 | Day |
Last modified on
| 2024 | 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=R000055402
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| Registered date | File name |
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