Tokyo, Sept. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062790) titled 'Effects of CPC/CAE-Containing Dental Rinse on Plaque, Gingivitis, and Oral Microbiota' on Sept. 2.

Study Type: Interventional

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

Primary Sponsor: Institute - Sunstar Inc.

Condition: Condition - Plaque accumulation and gingivitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify the effects of a CPC/CAE-containing dental rinse on plaque accumulation, gingivitis, and oral microbiota. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - From after screening until the end of the study, oral hygiene will be performed using designated toothpaste and toothbrush (twice daily). After the completion of the baseline assessment, in addition to the above, the use of a CPC/CAE-containing dental rinse twice daily will be initiated. The evaluation period will be 4 weeks, with intraoral examinations and plaque/saliva collection conducted every 2 weeks. Additionally, plaque and saliva collection will also be performed 1 day after the baseline assessment. Interventions/Control_2 - From after screening until the end of the study, oral hygiene will be performed using designated toothpaste and toothbrush (twice daily). After the completion of the baseline assessment, in addition to the above, the use of a placebo dental rinse twice daily will be initiated. The evaluation period will be 4 weeks, with intraoral examinations and plaque/saliva collection conducted every 2 weeks. Additionally, plaque and saliva collection will also be performed 1 day after the baseline assessment.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Individuals aged 20 years or older and under 70 years of age at the time of consent 2. Individuals from whom written informed consent has been obtained 3. Individuals who are able to comply with the visit schedule during the study period 4. Individuals who have 20 or more natural teeth 5. Individuals who present with moderate plaque accumulation and moderate gingivitis upon oral examination (representative 6 teeth) at screening (mean PI greater than 1, mean GI greater than 1) Key exclusion criteria - 1. Individuals with allergies to CPC, CAE, or GK2 2. Individuals with serious chronic diseases such as poorly controlled diabetes 3. Individuals who smoke 20 or more cigarettes per day 4. Individuals currently undergoing periodontal treatment or with severe periodontitis (mobile teeth or probing pocket depth of 6 mm or more) 5. Individuals with 5 or more untreated carious teeth 6. Individuals currently undergoing orthodontic treatment 7. Individuals who are pregnant, breastfeeding, or potentially pregnant 8. Individuals who have taken antibiotics within the past 1 month 9. Individuals deemed ineligible by the responsible dentist or dental hygienist Target Size - 70

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 01 Day Date of IRB - 2026 Year 09 Month 01 Day Anticipated trial start date - 2026 Year 09 Month 14 Day Last follow-up date - 2026 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071847

Disclaimer: Curated by HT Syndication.