UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056283 |
|---|---|
| Receipt number | R000064310 |
| Scientific Title | Evaluation of Wiping Edible Sesame Oils in the Oral Cavities of patients receiving parenteral nutrition |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2025/05/29 09:21:55 |
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Basic information
Public title
Evaluation of Wiping Edible Sesame Oils in the Oral Cavities of patients receiving parenteral nutrition using a three-group comparison
Acronym
Evaluation of Wiping Edible Sesame Oils in the Oral Cavities in Three Groups
Scientific Title
Evaluation of Wiping Edible Sesame Oils in the Oral Cavities of patients receiving parenteral nutrition
Scientific Title:Acronym
Evaluation of Wiping Edible Sesame Oils in the Oral Cavities
Region
| Japan |
Condition
Condition
Bedridden patients who are unable to take food orally due to cerebrovascular disease, dementia, etc.
Classification by specialty
| Geriatrics | Dental medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The applicant has previously investigated the effectiveness of oral hygiene management techniques using oral cleaning with edible sesame oil. In this study, the target is limited to those who receive parenteral nutrition, and the aim is to demonstrate the effectiveness of care by showing the effectiveness of care. To this end, we asked for the cooperation of a nursing care hospital and its inpatients, and conducted a one-month intervention by hospital staff, and evaluated the oral hygiene management method before and after the intervention using the number of bacteria on the tongue dorsum, the number of Candida on the tongue dorsum, the number of Pseudomonas aeruginosa on the tongue dorsum, the amount of moisture in the mouth, the oral mucosal cytology, and the ROAG assessment sheet.
Basic objectives2
Others
Basic objectives -Others
Through this research, we aim to demonstrate the effectiveness of the oral hygiene management methods proposed by researchers, and to propose new care methods using food to nurses and caregivers who are having difficulty with oral hygiene management, with the aim of leading to social implementation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacterial count on the dorsal surface of the tongue
Key secondary outcomes
Number of Candida on the tongue dorsum, number of Pseudomonas aeruginosa on the tongue dorsum, oral moisture content, oral mucosal cytology, ROAG assessment sheet
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food | Maneuver | Other |
Interventions/Control_1
The nursing and care staff at the facility will carry out oral wiping using edible roasted sesame oil four times a day (upon waking, in the morning, in the afternoon, and before going to bed) and brushing once a day (in the morning or afternoon) for 30 days.
Interventions/Control_2
The nursing and care staff at the facility will carry out oral wiping using edible sesame salad oil four times a day (upon waking, in the morning, in the afternoon, and before going to bed) and brushing once a day (in the morning or afternoon) for 30 days.
Interventions/Control_3
The nursing and care staff at the facility will carry out conventional oral wiping using tap water four times a day (upon waking, in the morning, in the afternoon, and before going to bed) and brushing once a day (in the morning or afternoon) for 30 days.
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
Patients who meet the following three conditions: they are unable to take in the necessary nutrients and fluids orally, so they receive parenteral nutrition; they are unable to manage their own oral hygiene (all C's on the BDR index); and they are 65 years of age or older.
Key exclusion criteria
Patients with difficulty opening their mouths and sesame allergies
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Toshiko |
| Middle name | |
| Last name | OGAWA |
Organization
Graduate School of Nursing, Chiba University
Division name
Division of Advanced Nursing Practice, Advanced Nursing Practice Course, Nursing Pathophysiology
Zip code
260-8672
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba,
TEL
043-226-2406
toshiko.og@chiba-u.jp
Public contact
Name of contact person
| 1st name | Toshiko |
| Middle name | |
| Last name | OGAWA |
Organization
Graduate School of Nursing, Chiba University
Division name
Division of Advanced Nursing Practice, Advanced Nursing Practice Course, Nursing Pathophysiology
Zip code
260-8672
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba,
TEL
043-226-2406
Homepage URL
toshiko.og@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Public Interest Incorporated Foundation, Isyoku-Dogen Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Graduate School of Nursing Ethics Review Committee
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba,
Tel
043-226-2462
kango-rinri@chiba-u.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
| 2024 | Year | 12 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 27 | Day |
Last modified on
| 2025 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064310
