Clinical Trial: An evaluation study on the effect of oral care instruction, including the use of rubber interdental brushes, on maintaining oral hygiene status at furcation involvement sites (Japan)

Tokyo, Sept. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062788) titled 'An evaluation study on the effect of oral care instruction, including the use of rubber interdental brushes, on maintaining oral hygiene status at furcation involvement sites' on Sept. 2.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Kobayashi Pharmaceutical Co., Ltd.

Condition: Condition - furcation involvement Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effect of oral care instruction, including guidance on the use of rubber interdental brushes, on the oral hygiene status of patients with furcation involvement.. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Patients will be instructed to brush their teeth at least twice daily using the designated oral care products (toothbrush and toothpaste), and to use a rubber interdental brush on the target site(s) at least once daily

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1) Male and female patients aged 20 to 79 years (inclusive) at the time of obtaining informed consent. 2) Patients who have at least one Class III furcation involvement (a lesion where a periodontal probe passes completely through the furcation) with a tooth mobility of degree 2 or less. 3) Patients with bleeding on probing (BOP) at the target furcation involvement site. 4) Patients who have not performed self-care using an interdental brush and dental floss at the target furcation involvement site for 3 months prior to and up to the time of obtaining informed consent. 5) Patients who have received a sufficient explanation of the purpose and details of the study, have fully understood them, have voluntarily decided to participate, and have provided written informed consent. Key exclusion criteria - 1) Patients currently receiving treatment for oral diseases, including periodontal disease (e.g., scaling, root planing, or surgical treatment). In addition, patients currently receiving care at any dental clinic other than the study site (Takai Dental Clinic). 2) Patients with a past or current history of psychiatric disorders. 3) Patients who have used oral antibiotics within 3 months prior to the start of the study. In addition, patients who have used bactericidal/antibacterial mouthwashes or oral anti-inflammatory drugs (e.g., NSAIDs) within 1 month prior to the start of the study. 4) Patients who are currently pregnant or breastfeeding, or who plan to become pregnant during the study period. 5) Patients with a history of allergic reactions to toothpaste or rubber. 6) Patients with excessive alcohol consumption habits (reference: 40 g or more of pure alcohol per day). 7) Patients who have a habit of smoking 1 pack (20 cigarettes) or more per day (heavy smokers). 8) Patients who plan to make significant changes to their lifestyle habits (e.g., diet, sleep, or exercise habits) during the study period, such as taking a long trip. 9) Patients with an extremely irregular diet, or those with irregular daily rhythms, such as shift workers or night-shift workers. 10) Patients currently participating in another clinical trial, those within 4 weeks of completing another clinical trial, or those planning to participate in another clinical trial after consenting to this study. 11) Other patients deemed inappropriate for the study by the Principal Investigator (e.g., patients who have difficulty using an interdental brush due to hand tremors, or patients for whom the insertion of an interdental brush is anatomically impossible). Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 27 Day Date of IRB - 2026 Year 08 Month 06 Day Anticipated trial start date - 2026 Year 09 Month 03 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071886

Disclaimer: Curated by HT Syndication.