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School Oral Health Intervention in Nepal

Primary Purpose

Dental Diseases

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Oral Health Counseling and promotion
Sponsored by
Cyberjaya University College of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Diseases

Eligibility Criteria

12 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria The school children, who have studied in the schools at least one year before the start of the study. Grade 7 Exclusion Criteria: - The school children, who were absent for more than one week before the start of the study

Sites / Locations

  • Paschimanchal Dental Home

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral Health Intervention group

Control group

Arm Description

Those receiving intervention of oral health and counselling.

Those who are not receiving counseling and promotion interventions

Outcomes

Primary Outcome Measures

DMFT index
The is the index developed by WHO. DMFT is the sum of the number of Decayed, Missing due to caries, and Filled Teeth in the permanent teeth. The highest score is 32 and lowest is zero
Oral Health Knowledge
The total oral health knowledge score was ranging from 0-9 being nine as the highest score. The response of the knowledge test was measures as: Yes = 1, No and Don't Know = 0.
Practice on oral health
Prevalence of children who had better practices of health. Proportion of those who have regular tooth brushing, mouth gargle, tongue cleaning, and dental flush
Health Seeking Behavior
Proportion of people who have improved health seeking behavior in intervention compared to control

Secondary Outcome Measures

Full Information

First Posted
March 11, 2023
Last Updated
March 31, 2023
Sponsor
Cyberjaya University College of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05811650
Brief Title
School Oral Health Intervention in Nepal
Official Title
Effect of School-based Oral Health Promotion and Counselling Interventions Among School Children in Nepal: A Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cyberjaya University College of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Oral health problems in school children are highly prevalent in Nepal. The investigators designed oral health counseling and promotion intervention in Kaski district of Nepal for six months. The study was conducted intervention covering dental check up, counseling, supporting with brush materials, toothpaste, and essentials. The investigators also trained school teachers to provide oral health education in school children and completed the endline data collection to assess the effect of intervention.
Detailed Description
Globally oral health diseases are common health problems in children. About 60-90% of school children are suffering from dental caries worldwide . Dental caries is the most prevalent condition included in the 2016 Global Burden of Disease Study, ranking the first for the decay of permanent teeth (2.3 billon people) and 12th for deciduous teeth (560 million children). The dental caries process begins with a small patch of demineralized (softened) enamel at the tooth surface and the destruction then spreads into the softer, sensitive part of the tooth beneath enamel (dentin). Common oral diseases among children are dental caries and periodontal diseases . Pain from teeth or mouth can compromise their concentration and their participation in school, thereby hampering not only their play and development but also denying them the full benefit of schooling. In addition, such oral health problems negatively affect a child in restricting their activities, reducing the ability to learn, and increasing the frequency of absenteeism from schools . The most common cause of the dental problem is due to lack of dental health education, negligence of treatment in an early stage. Children do not have the knowledge to choose proper toothpaste and brush which plays an important role to maintain their oral hygiene and prevention dental caries. To improve oral health conditions proper awareness level plays an important role. Also, the proper method of tooth brushing plays an important role to maintain oral health status. A national Pathfinder Survey. However, there is no evidence in higher grade children in schools. The problem is grave in school children and little or no interventions targeting children have been practiced in Nepal. Therefore, designing an effective intervention that addresses knowledge and behavior on oral health targeting school children is necessary because they are the most at-risk population of oral health problems in Nepal and elsewhere. The overall aim of this study is to assess the effect of oral health promotion and counseling interventions on knowledge and oral hygiene practices in school children in Pokhara, Nepal. A cluster randomized control trial study will be conducted in selected community schools of Kaski District of Nepal. We will select six schools for the intervention group and six schools for the control group. The study sample will be the school students in the selected schools of 7 and 8 Grades. The sampling frame will be determined after preparing the list of students totaling of 580 students (Intervention:290; Control:290). The investigator will measure students' demographic characteristics, knowledge, and practices in oral health. The study will be conducted one year of an intervention comprising oral health screening and counseling every three months in the intervention group and will examine the effect of school-based intervention after one year of intervention. This study is expected to provide evidence to develop strategies for oral health promotion in community schools in Nepal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention will target school teachers and school children for counseling and oral health promotion education
Masking
Participant
Masking Description
School Children in the control group will be in control and will not receive any intervention
Allocation
Non-Randomized
Enrollment
669 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Health Intervention group
Arm Type
Experimental
Arm Description
Those receiving intervention of oral health and counselling.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Those who are not receiving counseling and promotion interventions
Intervention Type
Behavioral
Intervention Name(s)
Oral Health Counseling and promotion
Intervention Description
The intervention was cluster randomized control trial in design. We select six schools for the intervention group and six schools for the control group. Follow-up of the intervention was done after six months of baseline. Impact of the intervention was assessed among the same participants who enrolled in the baseline. The interventions were done in every three months.
Primary Outcome Measure Information:
Title
DMFT index
Description
The is the index developed by WHO. DMFT is the sum of the number of Decayed, Missing due to caries, and Filled Teeth in the permanent teeth. The highest score is 32 and lowest is zero
Time Frame
6 months
Title
Oral Health Knowledge
Description
The total oral health knowledge score was ranging from 0-9 being nine as the highest score. The response of the knowledge test was measures as: Yes = 1, No and Don't Know = 0.
Time Frame
6 months
Title
Practice on oral health
Description
Prevalence of children who had better practices of health. Proportion of those who have regular tooth brushing, mouth gargle, tongue cleaning, and dental flush
Time Frame
6 month
Title
Health Seeking Behavior
Description
Proportion of people who have improved health seeking behavior in intervention compared to control
Time Frame
6 monhts

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria The school children, who have studied in the schools at least one year before the start of the study. Grade 7 Exclusion Criteria: - The school children, who were absent for more than one week before the start of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Kamal Pr Chapain, BDS, MPH
Organizational Affiliation
Paschimanchal Dental Home
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paschimanchal Dental Home
City
Pokhara
State/Province
Gandaki
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be shared with genuine request
IPD Sharing Time Frame
Immediately after the completion of the study
IPD Sharing Access Criteria
Request with email to PI

Learn more about this trial

School Oral Health Intervention in Nepal

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