Tokyo, Oct. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062706) titled 'A Clinical Study to Evaluate the Preventive Effects of a Dentifrice Containing Two Antibacterial Agents and Anti-inflammatory/Anti-bleeding Ingredients on Periodontal Disease' on Oct. 3.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - KSO Corporation
Condition:
Condition - Healthy male/female volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To comprehensively evaluate the effects of four weeks of use of the study-product on periodontal disease and to confirm its efficacy.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Continuous application of the toothpaste to the subjects, three times a day for 4 weeks.
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - Healthy male/female volunteers ranging in age from 40 to 64 years old.
Volunteers having mild-to-moderate gingivitis and/or periodontitis.
According to the clinical observation, volunteers having not less than one periodontal pocket with not less than 4 mm.
At the screening test, volunteers who were determined as a patient having not less than one tooth equipped with level-1 or 2 on the GI index.
Volunteers having no scaling about the observation region within the last one month to the current study.
Volunteers who habitually brush their teeth at least three times per day.
Volunteers having not less than four teeth whose labial/buccal surfaces are measurable among the six index teeth (FDI: 16, 12, 24, 36, 32, 44), or their alternatives (FDI: 17, 15, 11, 25, 37, 35, 31, 45).
Volunteers are not currently receiving treatment for some kind of periodontal disease and who have at least 20 teeth present.
Volunteers who gave informed consent to take part in this study after being provided with anexplanation of the protocol detail.
Key exclusion criteria - Volunteers judged as having dental caries (C3 or worse) or severe periodontal disease at the screening test.
Volunteers receiving medical treatment for diabetes, chronic kidney, digestive, lung or cancer diseases.
Volunteers having some kind of systemic disease, which has serious difficulty in participating in this study.
Volunteers with toothbrushing not less than five times a day.
Volunteers cannot stop taking or using medicines that may affect oral health during the study period.
Volunteers use dentifrices equivalent to the investigational product, professional-use dentifrices, or other dentifrices, mouthwashes that may affect the study results.
Women who are pregnant, breastfeeding, or planning to become pregnant during the study period.
Volunteers having their stimulated saliva with no more than 3.0 mL for 5 min and having been diagnosed with dry mouth.
Volunteers having stimulated saliva with no more than a pH of 6.2.
Volunteers having experience of allergies to the components of research products, metals, or medicines.
Volunteers equipped with removable denture, and/or dental implant on the evaluated teeth.
Volunteers currently undergoing orthodontic treatment.
Volunteers currently smoke.
Volunteers who have regularly used some kind of health food.
Volunteers who have took in some kind of antibiotic and/or antibacterial agent, regularly or within the last month to the screening test.
Volunteers currently participating in or willing to participate in research on other pharmaceuticals or foods, or research on applying cosmetics or drugs
Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 22 Day
Anticipated trial start date - 2026 Year 11 Month 08 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071799
Disclaimer: Curated by HT Syndication.
