UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061854 |
|---|---|
| Receipt number | R000070776 |
| Scientific Title | Impact of Digital Oral Health Education on Oral Health Literacy (OHL) of Mother-Child Pairs: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/10 |
| Last modified on | 2026/06/10 05:25:28 |
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Basic information
Public title
Impact of Digital Oral Health Education on Oral Health Literacy (OHL) of Mother-Child Pairs: A Randomized Controlled Trial
Acronym
DOHE-OHL Trial
Scientific Title
Impact of Digital Oral Health Education on Oral Health Literacy (OHL) of Mother-Child Pairs: A Randomized Controlled Trial
Scientific Title:Acronym
DOHE-OHL RCT
Region
| Asia(except Japan) |
Condition
Condition
Oral Health Literacy and Oral Health Status in Mother-Child Pairs
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of a smartphone application (WhatsApp) based oral health education intervention among Mother-Child pairs and to evaluate its impact on oral health literacy of mothers, oral hygiene status, and oral health outcomes of children compared with conventional oral health education.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in Oral Health Literacy (OHL) score among mothers after the intervention, measured using the Oral Health Literacy Assessment (OHLA) questionnaire.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Study Group: Mothers received conventional oral health education and oral health educational videos through WhatsApp. Videos were delivered twice per month on different Saturdays for three consecutive months.
Interventions/Control_2
Control Group: Mothers received conventional oral health education through classroom sessions using PowerPoint presentations, posters, and verbal instruction.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children aged 6 to 12 years enrolled in the selected schools. Mothers owning a smartphone with access to WhatsApp. Mother-child pairs willing to participate and provide informed consent.
Key exclusion criteria
Mother-child pairs without access to a smartphone or WhatsApp. Children or mothers with learning disabilities. Participants unwilling to provide consent or complete the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Dr Dharmashree |
| Middle name | |
| Last name | Satyarup |
Organization
Institute of Dental Sciences
Siksha 'O' Anusandhan (Deemed to be University)
Division name
Department of Public Health Dentistry
Zip code
751003
Address
Institute of Dental Sciences Siksha 'O' Anusandhan (Deemed to be University) Kalinga Nagar Bhubaneswar Odisha India
TEL
8008610999
dharmashree_s@yahoo.com
Public contact
Name of contact person
| 1st name | Dr Silpa |
| Middle name | |
| Last name | Dash |
Organization
Institute of Dental Sciences Siksha O Anusandhan Deemed to be University
Division name
Department of Public Health Dentistry
Zip code
751003
Address
Institute of Dental Sciences Siksha O Anusandhan (Deemed to be University) Kalinga Nagar Bhubaneswar
TEL
7978202172
Homepage URL
silpadash98@gmail.com
Sponsor or person
Institute
Institute of Dental Sciences
Siksha O Anusandhan (Deemed to be University)
Bhubaneswar, Odisha, India
Institute
Department
Personal name
Funding Source
Organization
Self-funded
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (IRB) Institute of Dental Sciences Siksha O Anusandhan (Deemed to be University)
Address
K-8, Kalinga Nagar Bhubaneswar, Odisha 751006 India
Tel
674 238 6907
info@soa.ac.in
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 | 06 | Month | 10 | Day |
Related information
URL releasing protocol
Not available
Publication of results
Unpublished
Result
URL related to results and publications
Not available
Number of participants that the trial has enrolled
80
Results
Eighty mother-child pairs were enrolled and completed the study. The intervention group received WhatsApp based oral health education in addition to conventional education, while the control group received conventional education only. Significant improvements were observed in oral health literacy among mothers and in plaque and gingival scores among children in the intervention group compared with the control group.
Results date posted
| 2026 | Year | 06 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 80 mother-child pairs were enrolled. Forty pairs were allocated to the intervention group and forty pairs to the control group. The mean age of children was 10.15 +/- 1.33 years in the intervention group and 9.33 +/- 1.50 years in the control group. The mean age of mothers was 33.82 +/- 4.99 years and 37.45 +/- 7.09 years, respectively. The majority of mothers had college or bachelor's level education.
Participant flow
Four schools were selected and randomized into intervention and control groups. Eighty eligible mother-child pairs were recruited and allocated equally to the intervention group (n=40) and control group (n=40). All enrolled participants completed the study and were included in the final analysis.
Adverse events
No adverse events, serious adverse events, or intervention related complications were reported during the study period. The WhatsApp based oral health education intervention was well tolerated by all participants.
Outcome measures
Primary Outcome: Oral Health Literacy (OHL) score among mothers measured using the Oral Health Literacy Assessment (OHLA) tool. OHL scores improved from 15.35 +/- 3.54 at baseline to 20.85 +/- 3.03 after intervention in the WhatsApp group, compared with 13.80 +/- 2.15 to 14.98 +/- 2.35 in the control group.
Secondary Outcomes: Plaque Index (Silness and Loe) and Gingival Index (Loe and Silness) among children. Plaque Index decreased from 2.26 +/- 0.46 to 1.04 +/- 0.34 in the intervention group and from 2.10 +/- 0.59 to 1.50 +/- 0.55 in the control group. Gingival Index decreased from 1.65 +/- 0.57 to 0.93 +/- 0.35 in the intervention group and from 1.49 +/- 0.58 to 1.28 +/- 0.56 in the control group. Significant improvements were observed in oral health literacy, plaque scores, and gingival scores in the intervention group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 30 | 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 | 06 | Month | 10 | Day |
Last modified on
| 2026 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070776
