Tokyo, July 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062188) titled 'A Randomized, Single-Blind, Crossover Trial Evaluating the Effect of Combined Toothbrushing and Interdental Cleaning Devices on Interdental Dental Plaque Removal in Middle-Aged and Older Adults' on July 9.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Osaka Dental University

Condition: Condition - Periodontal disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the effectiveness of combined toothbrushing with an interdental brush versus combined toothbrushing with dental floss for interdental dental plaque removal in middle-aged and older adults, and to evaluate cleaning time, cleaning efficiency, and user acceptability of each interdental cleaning device. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - interdental brush

Intervention Study participants will use interdental brushes at home for five days, beginning six days before the test. On the day of the test, after brushing their teeth with a standard toothbrush, they will clean the target interdental spaces using interdental brushes. Under a crossover design, Group A will undergo this intervention in Test I, and Group B will undergo it in Test II. Interventions/Control_2 - Holder-type dental floss

Intervention Study participants will use floss with a holder at home for five days, beginning six days before the test. On the day of the test, after brushing their teeth with a designated toothbrush, they will clean the target interdental spaces using floss with a holder. Under a crossover design, Group A will undergo this intervention in Test II, and Group B will undergo it in Test I.

Eligibility: Age-lower limit - 50 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Age 50 years or older 2. Having at least five interdental spaces in the molar region, excluding third molars, into which dental floss can be inserted Key exclusion criteria - 1. Presence of oral diseases, such as multiple dental caries or severe periodontitis 2. Unable to use interdental cleaning devices because of gingival swelling, suppuration, or other related conditions 3. Current use of anticoagulant medication 4. Considered ineligible by the investigator (dentist) for any other reason 5. Unable to use interdental cleaning devices appropriately Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 15 Day Date of IRB - 2026 Year 04 Month 13 Day Anticipated trial start date - 2026 Year 07 Month 10 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=R000071081

Disclaimer: Curated by HT Syndication.