Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059245) titled 'Examination of the effects of a food containing lactic acid bacteria WB21 and catechin (Avantbise Oral Tablets) on gingival condition and microorganisms in tongue coating' on Dec. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Fukuoka Dental College

Condition: Condition - gingival condition Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify whether the continuous intake of food containing lactic acid bacteria WB21, which has been reported to be useful in maintaining oral health, and epigallocatechin gallate, which is expected to have various physiological functions such as antioxidant and deodorizing effects, is effective in maintaining and promoting gingival health and oral flora in healthy adults. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Study participants were asked to lick three tablets of a food product containing Lactobacillus salivarius WB21 and epigallocatechin gallate (Avantbise Oral Tablets) daily, one tablet at a time, after meals and after brushing their teeth. Interventions/Control_2 - Study participants were asked to lick three tablets of a placebo containing no Lactobacillus salivarius WB21 or epigallocatechin gallate daily, one tablet at a time, after meals and after brushing their teeth.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Healthy adult men and women (2) Those who brush their teeth at least twice a day (3) Those with 20 or more teeth Key exclusion criteria - (1) Subjects with any oral symptoms (2) Subjects who regularly smoke (3) Subjects who wear dentures (4) Subjects who have received periodontal treatment within 3 months prior to the start of the study (5) Subjects who have taken antibiotics within 3 months prior to the start of the study (6) Subjects who have used toothpaste, mouthwash, or oral care supplements containing lactic acid bacteria within 1 month prior to the start of the study (7) Subjects with a history of digestive disorders (gastritis, gastric ulcer, colitis, etc.), diabetes, liver disease, kidney disease, serious respiratory disorders such as asthma, serious heart disease, or systemic disorders such as malignant tumors (8) Subjects who are or may be pregnant, or who are breastfeeding (9) Subjects with a history of milk allergies or food allergies to food ingredients (10) Subjects who are otherwise deemed inappropriate participants by the study director (11) Subjects who have participated in other clinical trials within 1 month prior to obtaining consent to participate in this study, or who plan to participate in other clinical trials after obtaining consent to participate in this study Target Size - 50

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 07 Month 15 Day Date of IRB - 2025 Year 09 Month 16 Day Anticipated trial start date - 2025 Year 09 Month 16 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067763

Disclaimer: Curated by HT Syndication.