Tokyo, June 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061997) titled 'An Exploratory Randomized Controlled Trial of the Effects of Deep Ocean Water on Oral Dryness Symptoms (Dry Mouth)' on June 22.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Toyama University Hospital

Condition: Condition - Xerostomia (Dry Mouth) Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 18 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 Size - 10

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070518

Disclaimer: Curated by HT Syndication.