Tokyo, May 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061294) titled 'Effects of a toothpaste containing beta-glucan on oral bacteria count' on May 1.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Kyushu Dental University

Condition: Condition - Dental caries Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the efficacy of a beta-glucan-containing dentifrice in modulating oral bacterial counts among healthy volunteers. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - beta-glucan-containing toothpaste group: Subjects will perform routine toothbrushing with the co-developed toothpaste containing beta-glucan for routine toothbrushing twice daily for 1 week. Interventions/Control_2 - Control toothpaste group (Placebo group): Subjects will perform toothbrushing under the same conditions as the intervention group, using a control toothpaste (placebo) that does not contain beta-glucan.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Male or female adults aged 18 years or older at the time of informed consent. 2. Subjects with clinically healthy gingiva. 3. Subjects who understand the study purpose and provide written informed consent. Key exclusion criteria - 1. Subjects with dental caries (excluding teeth requiring observation), gingivitis, or periodontitis. 2. Subjects who have taken antibiotics or anti-inflammatory drugs within the past month. 3. Current smokers. 4. Subjects currently undergoing dental treatment. 5. Regular users of electric toothbrushes. 6. Other individuals judged to be inappropriate for participation by the investigator. Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 31 Day Date of IRB - 2026 Year 04 Month 14 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070135

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