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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Caries in Children
• Intervention / Treatment: Behavioral: Supervised Virtual Toothbrushing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haya Alayadi; Phone Number: +966551679833; Email: halayadi@ksu.edu.sa
• Study Contact Backup: Name: Areej Alsiwat; Email: aalsiwat@ksu.edu.sa

Study Locations

• Saudi Arabia
  • Riyadh
    • Riyāḑ, Riyadh, Saudi Arabia, 12371
      • Recruiting
      • Haya Alayadi
      • Contact: Haya Alayadi, PhD; Phone Number: +966551679833; Email: halayadi@ksu.edu.sa
      • Contact: Areej Alsiwat; Phone Number: +966503447012; Email: aalsiwat@ksu.edu.sa
      • Sub-Investigator: Haifa A. Alakeel
      • Sub-Investigator: Munirh Alaskar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Control group will receive a videos five times a week that illustrate a unified toothbrushing technique and remind the child to brush their teeth.
Experimental: Intervention Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Brushing	The change in the frequency of brushing per day	1 year
Quality of Child's Daily Life	The impact of oral health on the child's daily life (QoL).	18 months

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Ministry of Health, Saudi Arabia
• Investigators: Principal Investigator: Haya Alayadi, PhD, King Saud University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Holland WW, Stewart S. Screening in health care. Benefit or bane? London: The Nuffield Provincial Hospitals Trust; 1990.
• World Health Organization. Oral health surveys: basic methods. 5th ed. Geneva: World Health Organization; 2013.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Quality of Life; Toothbrushing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: E-21-5925

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

This will be applied by pseudo-anonymization. A separate file all personal identifiable information for all subjects will be kept in a separate file by the principal investigator. In addition, 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.

Only the codes will be used in data entry without any identifiable personal information.

• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: Only the authorized team members will grant access to the study data.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No