Tokyo, Oct. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059490) titled 'A Study on the Effects of Gargling with Alkaline Ionized Water on Salivary Levels of Caries-Causing Bacteria' on Oct. 21.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Tokai University
Condition:
Condition - Dental caries
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effect of gargling with alkaline ionized water on the oral environment of healthy adults, with a particular focus on changes in salivary Streptococcus mutans levels.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Participants will gargle with alkaline ionized water three times daily, immediately after each meal (breakfast, lunch, and dinner), for a total of 30 consecutive days. Each gargling session will last approximately 30 seconds. The total daily amount of alkaline ionized water used is 500 milliliters.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Twenty functional teeth or more.
Able to provide written informed consent.
Key exclusion criteria - Known allergy or hypersensitivity to any mineral components in alkaline ionized water.
Medical conditions contraindicating gargling (e.g., dysphagia or severe oral dysfunction).
Ongoing dental treatment for active caries or other oral diseases that may affect study assessments.
Concurrent participation in other oral health programs or clinical studies that may influence the results of this study.
Target Size - 30
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2017 Year 10 Month 20 Day
Date of IRB - 2017 Year 11 Month 28 Day
Anticipated trial start date - 2018 Year 12 Month 01 Day
Last follow-up date - 2024 Year 12 Month 13 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068034
Disclaimer: Curated by HT Syndication.