UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061997 |
|---|---|
| Receipt number | R000070518 |
| Scientific Title | An Exploratory Randomized, Assessor-Blinded, Placebo-Controlled, Parallel-Group Trial to Evaluate the Effects of Deep Ocean Water Mouthwash on Oral Dryness Symptoms (Dry Mouth) |
| Date of disclosure of the study information | 2026/06/22 |
| Last modified on | 2026/06/22 08:52:38 |
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Basic information
Public title
An Exploratory Randomized Controlled Trial of the Effects of Deep Ocean Water on Oral Dryness Symptoms (Dry Mouth)
Acronym
DSW Dry Mouth Trial
Scientific Title
An Exploratory Randomized, Assessor-Blinded, Placebo-Controlled, Parallel-Group Trial to Evaluate the Effects of Deep Ocean Water Mouthwash on Oral Dryness Symptoms (Dry Mouth)
Scientific Title:Acronym
DSW-DM RCT
Region
| Japan |
Condition
Condition
Xerostomia (Dry Mouth)
Classification by specialty
| Medicine in general | Clinical immunology | Oto-rhino-laryngology |
| Oral surgery | Laboratory medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to exploratorily evaluate the effects of 4-week use of a deep ocean water mouthwash, compared with placebo, on oral dryness symptoms, salivary flow, oral mucositis, oral health-related quality of life, and salivary inflammatory biomarkers in patients with xerostomia (dry mouth).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in the xerostomia visual analog scale (VAS) score (0to100 mm) at 4 weeks after the start of intervention
Key secondary outcomes
Secondary outcomes include unstimulated salivary flow, stimulated salivary flow, oral mucositis score based on the modified WHO scale, oral health-related quality of life assessed using the Japanese version of OHIP-14, salivary biomarkers, and the frequency and details of adverse events at 4 and 6 weeks after the start of intervention. Exploratory subgroup analyses will also be performed according to the presence or absence of a history of radiation therapy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Other |
Interventions/Control_1
Deep ocean water group: Participants will use a deep ocean water-based mouthwash three times daily, 20 mL per use, for 4 weeks. The mouthwash will be held in the oral cavity for 30 seconds and then expectorated. Participants will be followed for 2 weeks after the intervention, for a total observation period of 6 weeks.
Interventions/Control_2
Placebo group: Participants will use a placebo mouthwash three times daily, 20 mL per use, for 4 weeks. The mouthwash will be held in the oral cavity for 30 seconds and then expectorated. Participants will be followed for 2 weeks after the intervention, for a total observation period of 6 weeks. After completion of the 6-week assessment, participants who wish to receive the deep ocean water mouthwash program will be offered the same regimen; data obtained after this post-trial provision will not be included in the primary analysis.
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
1. Patients who are outpatients or inpatients at the Department of Otorhinolaryngology, Head and Neck Surgery, or Internal Medicine of Toyama University Hospital, or the Department of Oral and Maxillofacial Surgery of Toyama City Hospital
2. Adult patients aged 18 years or older
3. Patients with subjective oral dryness and a xerostomia VAS score of 40 mm or higher
4. Patients with an unstimulated salivary flow rate of less than 0.2 mL/min or a Saxon test result of less than 2 g/2 min
5. Patients who are able to comply with the intervention and assessment schedule during the study period
6. Patients who have received an explanation of the purpose and methods of the study and have provided written informed consent
Key exclusion criteria
1. Patients with highly active inflammatory autoimmune diseases, such as Sjogren's syndrome, systemic lupus erythematosus, or rheumatoid arthritis.
2. Patients undergoing intensive chemotherapy who have oral mucositis of Grade 3 or higher according to CTCAE v5.0.
3. Patients with renal failure, defined as an estimated glomerular filtration rate of less than 30 mL/min/1.73 m2, or heart failure of NYHA class III or higher.
4. Patients with electrolyte abnormalities, defined as serum sodium less than 135 mEq/L or serum potassium 5.5 mEq/L or higher.
5. Patients with a history of allergy to seafood or mineral components.
6. Pregnant or lactating women.
7. Patients judged by the principal investigator to be inappropriate for participation in the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | YOSUKE |
| Middle name | |
| Last name | TAJIKA |
Organization
Toyama University Hospital
Division name
Laboratory of Anatomic Pathology
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama 930-0194, Japan
TEL
076-434-7745
tajika@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | YOSUKE |
| Middle name | |
| Last name | TAJIKA |
Organization
Toyama University Hospital
Division name
Laboratory of Anatomic Pathology
Zip code
9300194
Address
2630 Sugitani, Toyama, Toyama 930-0194, Japan
TEL
076-434-7745
Homepage URL
tajika@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical and Epidemiological Research Ethics Review Committee, University of Toyama
Address
2630 Sugitani, Toyama, Toyama 930-0194, Japan
Tel
076-415-8857
kenrinri@adm.u-toyama.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
| 2026 | Year | 06 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070518
