Tokyo, Sept. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062794) titled 'Effect of oral care using the Matching Transformation System on periodontal pathogens in patients with type 2 diabetes' on Sept. 2.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Akishima Clinic
Condition:
Condition - Type 2 diabetes
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of one year of oral care using the Matching Transformation System (MA-T) on periodontal pathogens in patients with type 2 diabetes
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - A 5-year oral care intervention using an MA-T-containing gel after each meal for patients with type 2 diabetes and periodontal disease
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Hemoglobin A1c level: 6.5-11.5%
Key exclusion criteria - eGFR: less than 45 mL/min/1.73 m2
Target Size - 100
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2024 Year 07 Month 01 Day
Date of IRB - 2024 Year 09 Month 22 Day
Anticipated trial start date - 2024 Year 11 Month 01 Day
Last follow-up date - 2029 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071795
Disclaimer: Curated by HT Syndication.
