UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058546 |
|---|---|
| Receipt number | R000066912 |
| Scientific Title | Development and Evaluation of a Patient-Participatory Oral Care Program Aimed at Promoting Salivary Secretion in Hemodialysis Patients |
| Date of disclosure of the study information | 2025/07/22 |
| Last modified on | 2026/09/17 13:48:08 |
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Basic information
Public title
Development and Evaluation of a Patient-Participatory Oral Care Program Aimed at Promoting Salivary Secretion in Hemodialysis Patients
Acronym
A Study on an Oral Care Program for Hemodialysis Patients
Scientific Title
Development and Evaluation of a Patient-Participatory Oral Care Program Aimed at Promoting Salivary Secretion in Hemodialysis Patients
Scientific Title:Acronym
A Study on an Oral Care Program for Hemodialysis Patients
Region
| Japan |
Condition
Condition
end stage renal disease (hemodialysis)
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to clarify whether implementing an oral care program to stimulate salivary secretion during hemodialysis sessions or at dialysis visits for hemodialysis patients can enhance salivary secretion function, improve oral health and dietary intake, elevate quality of life, and induce behavioral changes in oral care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dry mouth
Dry mouth assessed using the Xerostomia Inventory (XI) at baseline, 3 months, and 6 months after initiation of the intervention.
Key secondary outcomes
Secondary outcomes: Oral health status assessed using the Japanese version of the Oral Health Assessment Tool (OHAT-J), oral frailty assessed using the Oral Frailty 5-item Screening Tool (OF-5), severe periodontal disease screening score, oral bacterial count, oral mucosal moisture, health-related quality of life, nutritional parameters, dietary intake, stages of behavioral change related to oral care, and self-efficacy for oral care. Outcomes are assessed at baseline, 3 months, and 6 months, as applicable. Oral care implementation is also monitored throughout the intervention period.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Patients receiving maintenance hemodialysis participate in a six-month patient-participatory oral care program consisting of oral brushing, salivary gland massage, and tongue exercises. A nurse or dental hygienist provides initial instruction in the techniques. Technique and implementation are checked weekly during the first month and subsequently at monthly intervals. Participants perform the oral care themselves at least once per week during or around their dialysis visits.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who have obtained written and oral consent.
Key exclusion criteria
Hospitalized patients
Patients with cognitive impairment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Natsuka |
| Middle name | |
| Last name | Furusho |
Organization
Shimonoseki City University
Division name
Faculty of Nursing
Zip code
751-8510
Address
2-1 1 Daigaku-cho Shimonoseki
TEL
083-252-0288
furusho-na@shimonoseki-cu.ac.jp
Public contact
Name of contact person
| 1st name | Natsuka |
| Middle name | |
| Last name | Furusho |
Organization
Shimonoseki City University
Division name
Faculty of Nursing
Zip code
751-8510
Address
2-1-1 Daigaku-cho Shimonoseki
TEL
083-252-0288
Homepage URL
furusho-na@shimonoseki-cu.ac.jp
Sponsor or person
Institute
Shimonoseki City University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Grant-in-Aid for Scientific Research (C), Grant No. 24K13657
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
Shimonoseki City University
Address
2-1-1 Daigaku-cho Shimonoseki
Tel
083-252-0288
kenkyurinri@shimonoseki-cu.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 | 22 | 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
37
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 07 | 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 | 22 | Day |
Last modified on
| 2026 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066912
