Tokyo, May 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061512) titled 'Development and Efficacy Assessment of an Oral Health Education Program for Older Adults with Depressive Symptoms in Myanmar' on May 10.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Niigata University, Graduate School of Medicine, Dentistry and Health Sciences, Faculty of Dentistry
Division of Preventive Dentistry
Condition:
Condition - Depressive symptoms and oral disease in older adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effectiveness of a community-based oral health education program on oral health status in community-dwelling older adults aged 60 years and above, with and without depressive symptoms, in Yangon, Myanmar, over an 18-month follow-up period.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Those with depressive symptoms (Group 1): Oral health education program consisting of: (1) in-person slide-show presentations delivered in groups of 10 participants at 3-month intervals; (2) weekly reminder SMS messages; (3) an illustrated oral health education booklet.
Total duration: 18 months.
Interventions/Control_2 - Those with depressive symptoms (Group 2): Control.
No oral health education intervention.
Eligibility:
Age-lower limit - 60
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Community-dwelling older adults aged 60 years and above attending a township health centre in Yangon, Myanmar; able to provide informed consent
Key exclusion criteria - Cognitive impairment (MMSE score below threshold); severe systemic illness preventing participation; inability to attend follow-up; edentulous individuals; Unable to participate mentally and/or physically; Recent dental treatment < 6 months; Taking antidepressants or medicines that affect the saliva production
Target Size - 240
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 05 Month 01 Day
Date of IRB - 2023 Year 01 Month 27 Day
Anticipated trial start date - 2024 Year 08 Month 01 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070387
Disclaimer: Curated by HT Syndication.