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Impact of Virtual Supervised Tooth Brushing Among Primary School Children in Riyadh, KSA

Assess the Impact of Virtual Supervised Tooth Brushing on Dental Caries and Quality of Life Among Primary School Children in Riyadh, KSA

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05217316
Enrollment
1280
Registered
2022-02-01
Start date
2021-12-01
Completion date
2023-06-30
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries in Children

Keywords

Toothbrushing, Quality of Life

Brief summary

Dental caries is one of the most common diseases affecting children in Saudi Arabia despite the availability of free dental services. The combination of the large burden of untreated caries among school children, low uptake of dental services when asymptomatic and the availability of free dental services makes Saudi Arabia a unique setting for school-based dental programs. Despite the availability of free dental services provided through the Ministry of Health, universities' hospitals and health services of the Ministry of Defense, most Saudis visit the dentist only when in pain. As schools are carried out virtually and Saudi Arabia has proved effective IT infrastructure, virtual supervised tooth brushing is a proposed initiative. It is also an opportunity for targeting a large portion of the population with a high level of disease as a quarter of the Saudi population is younger than 15 years.

Detailed description

Background Dental caries is one of the most common diseases that afflict children in the Kingdom of Saudi Arabia and despite the availability of free dental services provided through the Ministry of Health, universities, hospitals and health services of the Ministry of Defense, most Saudis visit the dentist only when they are in pain thus, they reach the health care when they need complex care. Aim The aim is to assess the impact of virtual supervised toothbrushing on dental caries and quality of life among primary school children in Riyadh, KSA. Research Methodology This is a cluster randomized controlled trial comparing virtual supervised tooth brushing program against conventional oral hygiene program (lecture and tooth brushing demonstration). A 1280 children in 20 primary schools in Riyadh, Saudi Arabia will be recruited to the trail. Schools are the unit of clustering will be randomly selected and allocated to groups. Clinical assessment for dental caries will be conducted in four points (baseline, 6 months, 12 months, 18 months) by dental hygienist using World Health Organization criteria. Data on socio-demographic behavioral factors and children's quality of life will be collected at baseline and 12 months later through a structured questionnaire. The primary outcome is the change in the number of teeth with untreated dental caries in both primary and permanent teeth over 18 months. The secondary outcomes are the change in the frequency of brushing per day and the impact of oral health on the child's daily life (QoL). Research Significance Schools are carried out virtually and Saudi Arabia has proved effective IT infrastructure, virtual supervised tooth brushing is a proposed initiative. It is also an opportunity for targeting a large portion of the population with a high level of disease as a quarter of the Saudi population is younger than 15 years.

Interventions

BEHAVIORALSupervised Virtual Toothbrushing

A supervised virtual toothbrushing performed once a week for all students by dental hygienist that will be performed through a prescheduled virtual appointment for each child. All virtual appointments will be conducted using the collaboration of two national platforms. Mawid, a Ministry of health (MOH) Central Appointment System, to be used by the subjects. And ANAT system, a Saudi Commission for Health Specialists (SCHS) application for the hygienists to use for their virtual supervision.

Sponsors

Ministry of Health, Saudi Arabia
CollaboratorOTHER_GOV
King's College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

20 primary schools in Riyadh, Saudi Arabia will be recruited to the trail. Schools are the unit of clustering will be randomly selected and allocated to groups. The schools who did not respond and refused to participate will be dropped and replaced randomly from the selected list. All data entry and management will be carried out by the study principal investigator. This will be applied by pseudo-anonymization, an artificial identifier (code) will be assigned to each subject as he enrolled in the study. All the study team members will deal with coded data while collecting or analyzing information.

Intervention model description

This is a cluster randomized controlled trial comparing virtual supervised tooth brushing program against conventional oral hygiene program (lecture and tooth brushing demonstration). 1280 children in 20 primary schools in Riyadh, Saudi Arabia will be recruited to the trail. Schools are the unit of clustering. Schools will be randomly selected and allocated in two groups, intervention, and control group (10 schools for each group). Clinical assessment for dental caries will be conducted in four points (baseline, 6 months, 12 months, 18 months). Both groups will receive oral assessment and both will receive a videos five times a week that illustrate a unified toothbrushing technique and remind the child to brush their teeth. The intervention lies in which the intervention group will receive a supervised virtual toothbrushing performed once a week for each child.

Eligibility

Sex/Gender
ALL
Age
8 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

* Children aged 8 to 9 years (4th grade at school) at baseline * Both Saudis and non-Saudis * Children for whom the person with parental responsibility has signed the consent form

Exclusion criteria

* Children in 5th and 6th grade (11- 12-year-olds) as they would have left schools by the time of the follow-up assessment (18 months later). * Children who refuse to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Dental Caries18 monthsThe study primary outcome is the change in the number of teeth with untreated dental caries in both primary and permanent teeth over 18 months.

Secondary

MeasureTime frameDescription
Frequency of Brushing1 yearThe change in the frequency of brushing per day
Quality of Child's Daily Life18 monthsThe impact of oral health on the child's daily life (QoL).

Countries

Saudi Arabia

Contacts

Primary ContactHaya Alayadi
halayadi@ksu.edu.sa+966551679833
Backup ContactAreej Alsiwat
aalsiwat@ksu.edu.sa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026