Tokyo, July 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062196) titled 'Examination of the cleaning effect of continuous toothpaste use' on July 15.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Active
Primary Sponsor:
Institute - Kao Corporation
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To Evaluate the Cleaning effect of toothpaste NP214
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Use toothpaste NP214 over 2 times a day for 2 weeks
Interventions/Control_2 - Use placebo toothpaste over 2 times a day for 2 weeks
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Human aged 20-59
Key exclusion criteria - 1. Individuals with severe allergies or other drug hypersensitivities
2. Individuals with one of the five major diseases (cancer, stroke, acute myocardial infarction, diabetes, or mental illness) who are currently undergoing treatment at a medical facility or are scheduled for surgery or other
procedures
3. Pregnant women, women who may be pregnant, or women who are breastfeeding
4. Individuals who have taken antibiotics within the past 3 months
5. Individuals currently participating in other human trials related to oral care or food intake trials
6. Individuals who have had a tooth extracted or undergone dental surgery within the past 3 months
7. Individuals currently receiving oral treatment at a dental clinic
8. Individuals with five or more missing teeth at the time of enrollment (excluding wisdom tooth extractions and
extractions due to orthodontic treatment)
9. Individuals with visible oral trauma at the time of enrollment
10. Individuals with severe gingivitis at the time of recruitment
11. Individuals who smoke one or more cigarettes per day at the time of recruitment
12. Individuals who clean their tongue at least once a month at the time of recruitment
13. Individuals deemed unsuitable as study participants by the principal investigator due to violations of compliance obligations or other reasons"
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 06 Day
Date of IRB - 2026 Year 07 Month 06 Day
Anticipated trial start date - 2026 Year 07 Month 15 Day
Last follow-up date - 2027 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071175
Disclaimer: Curated by HT Syndication.