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

NCT05217316 | Unknown

• 1 other identifier: E-21-5925
• Study Type: interventional
• Target: 1,280
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries in Children

Keywords

Toothbrushing; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Dental Caries

  The study primary outcome is the change in the number of teeth with untreated dental caries in both primary and permanent teeth over 18 months.

  18 months

Secondary Outcomes (2)

• Frequency of Brushing

  1 year

• Quality of Child's Daily Life

  18 months

Study Arms (2)

Control Group

NO INTERVENTION

Control group will receive a videos five times a week that illustrate a unified toothbrushing technique and remind the child to brush their teeth.

Intervention Group

EXPERIMENTAL

Both groups 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 all students by dental hygienist that will be performed through a prescheduled virtual appointment for each child.

Behavioral: Supervised Virtual Toothbrushing

Interventions

Supervised Virtual Toothbrushing BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 8 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Ministry of Health, Saudi Arabia: collaborator

Study Sites (1)

Haya Alayadi

Riyāḑ, Riyadh Region, 12371, Saudi Arabia

RECRUITING

Related Publications (8)

• Almas K, Al-Malik TM, Al-Shehri MA, Skaug N. The knowledge and practices of oral hygiene methods and attendance pattern among school teachers in Riyadh, Saudi Arabia. Saudi Med J. 2003 Oct;24(10):1087-91.

  PMID: 14578974 BACKGROUND

• El Bcheraoui C, Tuffaha M, Daoud F, Kravitz H, AlMazroa MA, Al Saeedi M, Memish ZA, Basulaiman M, Al Rabeeah AA, Mokdad AH. Use of dental clinics and oral hygiene practices in the Kingdom of Saudi Arabia, 2013. Int Dent J. 2016 Apr;66(2):99-104. doi: 10.1111/idj.12210. Epub 2016 Jan 7.

  PMID: 26749526 BACKGROUND

• Al-Yousuf M, Akerele TM, Al-Mazrou YY. Organization of the Saudi health system. East Mediterr Health J. 2002 Jul-Sep;8(4-5):645-53.

  PMID: 15603048 BACKGROUND

• Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of untreated caries: a systematic review and metaregression. J Dent Res. 2015 May;94(5):650-8. doi: 10.1177/0022034515573272. Epub 2015 Mar 4.

  PMID: 25740856 BACKGROUND

• Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566.

  PMID: 28792274 BACKGROUND

• Holland WW, Stewart S. Screening in health care. Benefit or bane? London: The Nuffield Provincial Hospitals Trust; 1990.

  BACKGROUND

• World Health Organization. Oral health surveys: basic methods. 5th ed. Geneva: World Health Organization; 2013.

  BACKGROUND

• Alayadi H, Alsiwat A, AlAkeel H, Alaskar M, Alwadi M, Sabbah W. Impact of virtual supervised tooth brushing on caries experience and quality of life among primary school children: study protocol for a randomized controlled trial. Trials. 2023 Feb 20;24(1):118. doi: 10.1186/s13063-023-07111-8.

  PMID: 36803406 DERIVED

Study Officials

• Haya Alayadi, PhD

  King Saud University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haya Alayadi

CONTACT

+966551679833; halayadi@ksu.edu.sa

Areej Alsiwat

CONTACT

aalsiwat@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: February 1, 2022
• Study Start: December 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 2 years
• Access Criteria: Only the authorized team members will grant access to the study data.

Locations

SA (1)