UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058355 |
|---|---|
| Receipt number | R000064995 |
| Scientific Title | Experimental study on the residual rate of dental plaque after oral care for patients with trismus -Quantitative evaluation using a dental simulator- |
| Date of disclosure of the study information | 2025/07/03 |
| Last modified on | 2025/07/03 11:20:53 |
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Basic information
Public title
Experimental study on the residual rate of dental plaque after oral care for patients with trismus
-Quantitative evaluation using a dental simulator-
Acronym
Experimental study on oral care for patients with trismus
Scientific Title
Experimental study on the residual rate of dental plaque after oral care for patients with trismus
-Quantitative evaluation using a dental simulator-
Scientific Title:Acronym
Experimental study on the residual rate of dental plaque after oral care for patients with trismus
-Quantitative evaluation using a dental simulator-
Region
| Japan |
Condition
Condition
trismus
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to quantitatively evaluate how much plaque can be removed through oral care in patients with severe trismus, and in which areas plaque is likely to remain.
Basic objectives2
Others
Basic objectives -Others
Comparative evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Residual area of paint on model teeth in dental simulator
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention 1: Oral care using swabs for patient with severe trismus - 7days of washout period - Oral care using swabs for patient without trismus
Interventions/Control_2
Intervention2: Oral care using swabs for patient without trismus - 7days of washout period - Oral care using swabs for patient with severe trismus
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
| 22 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Have a total of two or more years of practical experience as a nurse.
2) 1), Also currently provides oral care on a daily basis in hospitals, nursing homes, visiting nurse stations, etc.
Key exclusion criteria
1)Those who have not performed routine oral care as part of their nursing duties for the past six months or more due to childcare leave, etc.
2)Those who have been away from nursing practice for six months or more, but have returned to work for less than three months.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Sakamoto |
Organization
Wakayama Medical University
Division name
School of Health and Nursing Science
Zip code
641-0011
Address
580 Mikazura, Wakayama City Japan
TEL
+81-73-446-6700
sakamoto-nc@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Sakamoto |
Organization
Wakayama Medical University
Division name
School of Health and Nursing Science
Zip code
641-0011
Address
580 Mikazura, Wakayama City Japan
TEL
+81-73-446-6700
Homepage URL
sakamoto-nc@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kansai University of social welfare
Name of secondary funder(s)
Kansai University of social welfare
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
+81-73-447-2300ext.3692, 3693
wa-rinri@wakayama-med.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
| 2025 | Year | 07 | Month | 03 | 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
| 2025 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2025 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064995
