Examining the Impact of School-based Dental Screening

Dental Caries Clinical Trial

Official title:

Examining the Impact of School-based Dental Screening Program on Dental Visits and Dental Caries Among Primary School Children in Riyadh City, Saudi Arabia: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345680
• Other study ID #: HR-16/17-4683
• Status: Completed
• Phase: N/A
• Start date: October 10, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: October 2017
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines the effectiveness of school dental screening in promoting dental attendance and reducing untreated caries among primary schoolchildren in Riyadh, Saudi Arabia.

Description:

Background: Dental caries is one of the most common diseases affecting children in Saudi Arabia despite the availability of free dental services. School-based dental screening could be a potential intervention that might impact uptake of service and subsequently dental caries.

Aim: To examine the effectiveness of school dental screening in promoting dental attendance and reducing untreated caries among primary schoolchildren in Riyadh, Saudi Arabia.

Methods: This is a cluster randomized controlled trial comparing referral of screened-positive children to a specific treatment facility (King Saud University Dental College Hospital) against the current practice (information letter advising parents to take their child to a dentist). A total of 1000 children in 12 schools will be recruited. Schools (clusters) will be randomly selected and allocated to either group using computer software. Clinical assessment for dental caries will be conducted at baseline and after 12 months by dentists using the World Health Organisation (WHO) criteria. Different clinical teams will be used for each trial group to ensure blinded outcome assessment. Data on socio-demographic, behavioural and dental visits will be collected at baseline and follow-up. Outcome measures will be the change in number of decayed teeth and the number of dental visits over 12 months.

Discussion: This project will use a robust design to provide high level of evidence on the clinical benefits of school dental screening. The findings will potentially inform policies related to the continuation/ implementation of school-based dental screening in Saudi Arabia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 996
• Est. completion date: January 1, 2020
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children aged 6 to 11 years (1st -5th 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 6th grade (12-year-olds) as they would have left schools by the time of the follow-up assessment (12 months later).

• Children with any medically compromised condition such as congenital heart disease, haematological conditions, immune deficiency disease and end-stage renal disease.

• Children that refuse to participate (assent) in the study.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Referred to a specific hospital for treatment
To King Saud University Dental College, treatment will be provided free of charge to the referred participants.

Locations

Country	Name	City	State
United Kingdom	King's College London	London	Great Britin

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	King Saud University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the number of decayed teeth (untreated caries)	the change in the number of decayed teeth (untreated caries) in both primary and permanent teeth 12 months after intervention.	12 months
Secondary	Changes in the proportion of children with untreated caries and whether the child visited the dentist	The change in the proportion of children with untreated caries in both deciduous and permanent teeth and whether the child visited the dentist	12 months