UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052980 |
|---|---|
| Receipt number | R000060442 |
| Scientific Title | Efficacy of supervised toothbrushing program among school children in Kavrepalanchowk district of Nepal: A cluster randomized controlled trial. |
| Date of disclosure of the study information | 2023/12/03 |
| Last modified on | 2026/08/09 15:56:16 |
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Basic information
Public title
School oral health promotion in Nepal
Acronym
School oral health promotion in Nepal
Scientific Title
Efficacy of supervised toothbrushing program among school children in Kavrepalanchowk district of Nepal: A cluster randomized controlled trial.
Scientific Title:Acronym
Efficacy of supervised toothbrushing program among school children in Kavrepalanchowk district of Nepal: A cluster randomized controlled trial
Region
| Asia(except Japan) |
Condition
Condition
Oral Diseases
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effective school-based oral health intervention among primary school children (aged around 7-9 years) who attend class 3-4 in government schools in Kavrepalanchowk district of Nepal through and to identify the factors that influence their oral health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Oral hygiene index, 3 months after
Key secondary outcomes
Toothbrushing frequency
Oral health knowledge
Consumption of sugary foods Self-assessment of oral health status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Three months oral health promotion programme by conducing toothbrushing with fluoride toothpaste under the school teachers supervision, which is an intervention arm
Interventions/Control_2
Control arm with no intervention
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
| 7 | years-old | <= |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. A school located within a 1.5-2hour distance from Dhulikhel Hospital.
2. Public elementary school.
3. Schools interested in participating in this study without any conflicts of interest.
4. Schools whose principals are cooperative with this research.
5. Schools where the necessary water infrastructure for research is in place.
Key exclusion criteria
1. Children aged 7 and under, as well as those aged 9 and above.
2. Children who do not consent to participate in the research.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Dilip Prajapati |
| Middle name | |
| Last name | Prajapati |
Organization
Dhulikhel Hospital Kathmandu University Hospital
Division name
Community Dentistry
Zip code
45200
Address
Dhulikhel 45200
TEL
+97711490497
phdentistry@kusms.edu.np
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Harada |
Organization
Tokyo Womens Medical University
Division name
Section of Global Health, Department of Hygiene and Public Health
Zip code
1209
Address
8-1 Kawada-cho, Tokyo, Japan
TEL
0764584288
Homepage URL
harada.yuriko@twmu.ac.jp
Sponsor or person
Institute
Tokyo Womens Medical University
Institute
Department
Personal name
Yuriko Harada
Funding Source
Organization
Lotte Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women Medical University
Address
8-1 Kawada-cho, Tokyo, Japan
Tel
+81 3-3353-8111
harada.yuriko@twmu.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
| 2023 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
580
Results
The supervised school-based toothbrushing intervention resulted in greater improvements in oral hygiene and gingival health compared with the control group. In the intervention group, the mean Plaque Index (PI) decreased from 1.4 at baseline to 1.2 at endline, while the mean Gingival Index (GI) decreased from 1.3 to 1.1. In the control group, smaller reductions were observed, with PI decreasing from 1.4 to 1.3 and GI decreasing from 1.2 to 1.2.
Results date posted
| 2026 | Year | 06 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
At baseline, a total of 580 participants were included (309 in the control group and 271 in the intervention group). The distribution of gender was similar between groups, with no substantial imbalance observed. Baseline plaque index and gingival index values were also comparable between the control and intervention groups, indicating that the two groups were well balanced prior to the intervention.
Participant flow
A total of 580 participants were included in baseline (309 in the control group and 271 in the intervention group). At endline, 540 participants remained, corresponding to a loss to follow-up.
Adverse events
No adverse events related to the intervention were reported during the study period.
Outcome measures
The primary outcome of the study was the plaque index (PI), and the secondary outcome was the gingival index (GI). Clinical oral examinations were conducted at baseline and endline using standardized procedures. In addition, a structured questionnaire was administered to assess toothbrushing behavior, use of fluoridated toothpaste, and oral health-related school absenteeism.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2023 | Year | 12 | Month | 03 | Day |
Last modified on
| 2026 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060442
