Clinical trial NCT05811650: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Diseases
Lead sponsor: Cyberjaya University College of Medical Sciences
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 669
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention will target school teachers and school children for counseling and oral health promotion education
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: DMFT index
timeFrame: 6 months
measure: Oral Health Knowledge
timeFrame: 6 months
measure: Practice on oral health
timeFrame: 6 month
measure: Health Seeking Behavior
timeFrame: 6 monhts
Secondary outcomes:
Other outcomes:
Locations:
city: Pokhara
country: Nepal
facility: Paschimanchal Dental Home
state: Gandaki
Study officials:
affiliation: Paschimanchal Dental Home
name: Dr. Kamal Pr Chapain, BDS, MPH
role: PRINCIPAL_INVESTIGATOR
References: