Study design and subjects
tooth mobility, bleeding, swelling, periodontitis, caries, allergic symptoms
RECRUITMENT, BLEEDING, PERIODONTITIS, DIABETES MELLITUS, CARIES
This was a randomized, single‐blind, controlled, and parallel group comparative study performed at Sunstar Senri Dental Clinic, Affiliated with the Sunstar Foundation, from July to October 2020, and included adult volunteers aged 30–60 years. Recruitment of subjects was performed by 3H Medi Solution Inc., and the study information was published on their web media or email newsletter. The subjects meeting the following eligibility criteria were included: (1) provided written informed consent for participation; (2) male and female subjects aged 30–60 years at the time of acquisition of consent; and (3) having 24 or more natural teeth, including top, bottom, right, and left molars. Exclusion criteria were as follows: (1) taking any oral substances (e.g., antimicrobial drug, antibiotics) with potential impacts on the oral microflora; (2) using mouthwash, dental rinse, or interdental brush and dental floss; (3) conducting tongue cleaning daily; (4) smokers; (5) undergoing treatment for diabetes mellitus; (6) scheduled to undergo dentistry medical treatment during the study period; (7) pregnant or lactating women; (8) previously exhibited allergic symptoms to the test product or its formulation ingredient; (9) multiple caries (five or more C2); (10) severe periodontitis (marked inflammatory) (e.g., pus discharge, spontaneous bleeding, swelling, periodontal pocket, tooth mobility); and (11) any individual considered inappropriate for inclusion in the study by the subinvestigator.