Dental DiseasesNCT05811650
School Oral Health Intervention in Nepal
A study testing Oral Health Counseling and promotion in people with Dental Diseases, run by Cyberjaya University College of Medical Sciences at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Diseases
- What is being tested?
- Oral Health Counseling and promotion
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 669 participants
- Where
- 1 siteNepal
- Study dates
- 10 Feb 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The school children, who have studied in the schools at least one year before the start of the study.
- Grade 7
Who cannot join
- The school children, who were absent for more than one week before the start of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of School-based Oral Health Promotion and Counselling Interventions Among School Children in Nepal: A Cluster Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Dental Diseases
- Being tested
- Oral Health Counseling and promotion
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Health Counseling and promotionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Health Intervention group | Experimental | Those receiving intervention of oral health and counselling. Receives: Behavioral: Oral Health Counseling and promotion |
| Control group | Placebo comparator | Those who are not receiving counseling and promotion interventions Receives: Behavioral: Oral Health Counseling and promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 6 month
Health Seeking Behavior
Proportion of people who have improved health seeking behavior in intervention compared to control
Measured: 6 monhts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start10 Feb 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will target school teachers and school children for counseling and oral health promotion education
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 669 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyberjaya University College of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamal Prasad Chapain, Cyberjaya University College of Medical Sciences
- Investigators
- Dr. Kamal Pr Chapain, BDS, MPH, Principal investigator, Paschimanchal Dental Home
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811650
- Sponsor's protocol ID
- CNP-1-PHD-1901001
- Status last verified
- Mar 2023
- First submitted
- 11 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared with genuine request
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of School-based Oral Health Promotion and Counselling Interventions Among School Children in Nepal: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05811650
- Acronym / sponsor ID
- CNP-1-PHD-1901001
- Conditions
- Dental Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 669 participants (actual)
- Lead sponsor
- Cyberjaya University College of Medical SciencesUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The intervention will target school teachers and school children for counseling and oral health promotion education
| Arm | Type | Receives |
|---|---|---|
| Oral Health Intervention group | Experimental | Behavioral: Oral Health Counseling and promotionThose receiving intervention of oral health and counselling. |
| Control group | Placebo comparator | Behavioral: Oral Health Counseling and promotionThose who are not receiving counseling and promotion interventions |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The school children, who have studied in the schools at least one year before the start of the study.
- Grade 7
Key exclusion criteria (1 listed)
- The school children, who were absent for more than one week before the start of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Health Counseling and promotionThe 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. | Behavioural | Control group, Oral Health Intervention group |
Primary outcome
DMFT index
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: 6 month
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
Time frame: 6 monhts
Proportion of people who have improved health seeking behavior in intervention compared to control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared with genuine request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Kamal Pr Chapain, BDS, MPH principal investigator
Paschimanchal Dental Home
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Health Counseling and promotion in people with Dental Diseases, run by Cyberjaya University College of Medical Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DMFT index (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.