NCT05811650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
669

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
Last Updated

April 13, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

March 11, 2023

Last Update Submit

March 31, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

    6 months

  • 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.

    6 months

  • 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

    6 month

  • Health Seeking Behavior

    Proportion of people who have improved health seeking behavior in intervention compared to control

    6 monhts

Study Arms (2)

Oral Health Intervention group

EXPERIMENTAL

Those receiving intervention of oral health and counselling.

Behavioral: Oral Health Counseling and promotion

Control group

PLACEBO COMPARATOR

Those who are not receiving counseling and promotion interventions

Behavioral: Oral Health Counseling and promotion

Interventions

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.

Control groupOral Health Intervention group

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The school children, who have studied in the schools at least one year before the start of the study.
  • Grade 7

You may not qualify if:

  • \- The school children, who were absent for more than one week before the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paschimanchal Dental Home

Pokhara, Gandaki, Nepal

Location

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

  • Dr. Kamal Pr Chapain, BDS, MPH

    Paschimanchal Dental Home

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
School Children in the control group will be in control and will not receive any intervention
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The intervention will target school teachers and school children for counseling and oral health promotion education
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD scholar

Study Record Dates

First Submitted

March 11, 2023

First Posted

April 13, 2023

Study Start

February 10, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2022

Last Updated

April 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Individual participant data will be shared with genuine request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Immediately after the completion of the study
Access Criteria
Request with email to PI

Locations