Tokyo, April 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061206) titled 'A Comparative Study of the Effectiveness of Brushing and L8020 Application in Reducing Oral Bacterial Counts in Intubated Patients: A Preliminary Study' on April 9.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - others
Condition:
Condition - Patients on endotracheal intubation
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study examines patients under endotracheal intubation to determine whether brushing or the application of L8020 mouthwash which has an inhibitory effect on periodontal and cariogenic bacteria is more effective at reducing bacterial counts in oropharyngeal fluid.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - After performing oral care, apply L8020.
Interventions/Control_2 - After performing oral care, apply tap water.
Eligibility:
Age-lower limit - 45
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients in the ICU who are intubated due to cerebrovascular disease, cardiovascular disease, or severe infection.
2. Patients aged 45 years or older
3. Patients for whom consent has been obtained from the patient, their family, or a surrogate decision-maker after receiving a thorough explanation and demonstrating a full understanding of the study (since the patient is intubated and consent cannot be obtained prior to intubation).
Key exclusion criteria - 1. Patients with conditions other than the target disease.
2. Patients with edentulism.
3. Patients who do not consent to participate in the study.
4. Any other patients deemed unsuitable for the study by the principal investigator or other study personnel.
Target Size - 20
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 03 Month 31 Day
Date of IRB - 2026 Year 03 Month 09 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070036
Disclaimer: Curated by HT Syndication.
