UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060522 |
|---|---|
| Receipt number | R000069236 |
| Scientific Title | Evaluation of an Oral Care Method Using a Moisture-Permeable Oral Care Gel |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/01/30 14:55:09 |
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Basic information
Public title
Evaluation of an Oral Care Method Using a Moisture-Permeable Oral Care Gel
Acronym
Evaluation of an Oral Care Method Using a Moisture-Permeable Oral Care Gel
Scientific Title
Evaluation of an Oral Care Method Using a Moisture-Permeable Oral Care Gel
Scientific Title:Acronym
Evaluation of an Oral Care Method Using a Moisture-Permeable Oral Care Gel
Region
| Japan |
Condition
Condition
Patients in the acute hospital
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the effects of using a highly permeable oral care gel on improving work efficiency in oral care for hospitalized patients and maintaining oral mucosal hydration.
Basic objectives2
Others
Basic objectives -Others
Oral Moisture Level After Using Oral Care Gel
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survey on the Quality of Oral Care for Oral Care Practitioners
Key secondary outcomes
Moisture level one hour after oral care
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
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Highly permeable oral moisturizer
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Study Population
Hospitalized patients with poor oral hygiene who were determined to require oral care and exhibited oral eschar.
Eligibility Criteria
(1) Aged 20 years or older
(2) Patients for whom oral care was requested by the attending physician
(3) Presence of oral eschar at the time of the initial oral care intervention by the oral surgeon
Key exclusion criteria
Exclusion Criteria
(1)Significantly unstable respiratory or circulatory status
(2) Inability to maintain an open mouth position
(3) Significant difficulty performing oral care involving instrument contact due to oral mucosal disease
(4) Presence of significant pain
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Mori |
Organization
Southern Tohoku General Hospital
Division name
Dept. of Oral Maxxlloifacial surgery
Zip code
9638563
Address
7-115 Yatsuyama, Koriyama City, Fukushima Prefecture
TEL
024-934-5322
tmori0117@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Mori |
Organization
Southern Tohoku General Hospital
Division name
Dept. of Oral Maxxlloifacial surgery
Zip code
963-8563
Address
7-115 Yatsuyama, Koriyama City, Fukushima Prefecture
TEL
024-934-5322
Homepage URL
tmori0117@yahoo.co.jp
Sponsor or person
Institute
Southern Tohoku General Hospital
Institute
Department
Personal name
Talashi Mori
Funding Source
Organization
self-procurement
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
Southern TohokuGeneral Hospital IRB
Address
7-115 Yatsuyama, Koriyama City, Fukushima Prefecture
Tel
024-934-5322
rinri@mt.strins.or.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 | 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
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 | 12 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 25 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 25 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069236
