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

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05217316
• Other study ID #: E-21-5925
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: June 2023

Study information

• Verified date: January 2022
• Source: King's College London
• Contact: Haya Alayadi
• Phone: +966551679833
• Email: halayadi[@]ksu.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1280
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	Haya Alayadi	Riya?	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Ministry of Health, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (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. Review. — View Citation

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. — View Citation

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. — View Citation

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

Kassebaum NJ, Bernabé 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. Review. — View Citation

Kassebaum NJ, Smith AGC, Bernabé 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. Review. — View Citation

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

Outcome

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