Tokyo, Oct. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059273) titled 'Preliminary study on the effect of pre-bedtime oral care on the oral environment upon early morning awakening' on Oct. 11.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Wakayama Medical University

Condition: Condition - Healthy people Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate the effect of oral care using mouthwash before bedtime on the number of oral bacteria and oral moisture content upon waking the next morning in healthy middle-aged and elderly adults. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Intervention 1: One day of oral care including brushing and rinsing with mouthwash before going to bed - Two-day washout period - One day of oral care including brushing and rinsing with distilled water before going to bed Interventions/Control_2 - Intervention 2: One day of oral care including brushing and rinsing with distilled water before going to bed - Two-day washout period - One day of oral care including brushing and rinsing with mouthwash before going to bed

Eligibility: Age-lower limit - 40 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Participants who can gargle with mouthwash. 2) Participants who do not normally use mouthwash. 3) Participants who can use the toothpaste used in the study during the study period. 4) Participants who can adjust to the designated wake-up time during the study period. Key exclusion criteria - 1) Subjects currently undergoing dental treatment, such as caries treatment 2) Subjects who have received antibiotic treatment within the past two weeks 3) Subjects with no teeth 4) Subjects who have a habit of drinking fluids between the time of bedtime and the time of waking the next morning Target Size - 15

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 09 Month 22 Day Date of IRB - 2025 Year 10 Month 03 Day Anticipated trial start date - 2025 Year 10 Month 10 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067797

Disclaimer: Curated by HT Syndication.