Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062133) titled 'The test of the toothpaste' on Sept. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Kao Corporation
Condition:
Condition - Periodontal disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the efficacy of the oral composition 20260528.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Brush teeth at least twice a day using oral care product 20260528 for 12wks.
Interventions/Control_2 - Brush teeth at least twice a day using placebo for 12wks.
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Male and Female
Key inclusion criteria - -Men and women aged 40 to 65
-People who meet either criterion 1 or 2 below, and also meet any one of criteria 3, 4, or 5
1. You feel like your gums have receded and your teeth have become longer
2. You feel like food gets stuck between your teeth
3.Your gums sometimes bleed when you brush your teeth
4. Your gums sometimes swell
5. You have been told that your gums are swollen or that your periodontal pockets are deep
-People who have 20 or more of their own teeth
-People who brush their teeth at least twice a day
Key exclusion criteria - -People with diabetes, heart disease, kidney disease, liver disease, or other conditions that affect overall bodily function
-Individuals taking medication prescribed by a doctor for a medical condition (excluding allergy medication)
-Individuals currently receiving medical treatment for oral conditions other than periodontal disease
-Individuals currently undergoing treatment for periodontal disease
-Individuals currently undergoing orthodontic treatment
-Individuals with loose teeth
-Individuals who have undergone dental implant treatment
-Individuals who visit the dentist regularly at least three times a year
-Women who are pregnant or plan to become pregnant during the study period
-Smokers
-Individuals who are already participating in another study at the time of the study briefing, or who plan to participate in another study during the period of participation in this study
-Individuals or their household members who are employed by advertising agencies, research or consulting firms, media, or the manufacturing or distribution of health foods, cosmetics, toiletries, or hygiene products
-Any other individuals deemed unsuitable for study participation by study personnel
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 30 Day
Date of IRB - 2026 Year 06 Month 30 Day
Anticipated trial start date - 2026 Year 09 Month 01 Day
Last follow-up date - 2026 Year 12 Month 25 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071096
Disclaimer: Curated by HT Syndication.