UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061512 |
|---|---|
| Receipt number | R000070387 |
| Scientific Title | Development and Efficacy Assessment of an Oral Health Education Program for Older Adults with Depressive Symptoms in Myanmar |
| Date of disclosure of the study information | 2026/05/10 |
| Last modified on | 2026/05/10 19:18:41 |
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Basic information
Public title
Development and Efficacy Assessment of an Oral Health Education Program for Older Adults with Depressive Symptoms in Myanmar
Acronym
Development and Efficacy Assessment of an Oral Health Education Program for Older Adults with Depressive Symptoms in Myanmar
Scientific Title
Development and Efficacy Assessment of an Oral Health Education Program for Older Adults with Depressive Symptoms in Myanmar
Scientific Title:Acronym
Development and Efficacy Assessment of an Oral Health Education Program for Older Adults with Depressive Symptoms in Myanmar
Region
| Asia(except Japan) |
Condition
Condition
Depressive symptoms and oral disease in older adults
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Modified Plaque Index
Key secondary outcomes
DMFT index; pocket depth; bleeding on probing; resting and stimulated salivary flow rate; oral bacterial count; Oral Health Impact Profile-14 (OHIP-14); DASS-21 (depression, anxiety, stress); Activities of Daily Living (ADL); Instrumental ADL (IADL); Geriatric Depression Scale-15 (GDS-15)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
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.
Interventions/Control_3
Those without depressive symptoms (Group 3): 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_4
Those without depressive symptoms (Group 2): Control.
No oral health education intervention.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Kaung Myat |
| Middle name | |
| Last name | Thwin |
Organization
Niigata University, Graduate School of Medicine, Dentistry and Health Sciences, Faculty of Dentistry
Division name
Division of Preventive Dentistry
Zip code
951-8514
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata-shi, Niigata, Japan
TEL
0252272858
kaung@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaung Myat |
| Middle name | |
| Last name | Thwin |
Organization
Niigata University, Graduate School of Medicine, Dentistry and Health Sciences, Faculty of Dentistry
Division name
Division of Preventive Dentistry
Zip code
9518514
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata-shi, Niigata, Japan
TEL
817021745789
Homepage URL
kaung@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University, Graduate School of Medicine, Dentistry and Health Sciences, Faculty of Dentistry
Division of Preventive Dentistry
Institute
Department
Personal name
Kaung Myat Thwin
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) KAKENHI Grant-in-Aid for Early-Career Scientists, Grant Number 24K20102
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Niigata University
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata-shi, Niigata, Japan
Tel
+81252272858
kaung@dent.niigata-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
245
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 10 | Day |
Last modified on
| 2026 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070387
