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Completed

NCT Number: NCT03345680

Examining the Impact of School-based Dental Screening

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

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College London

London, Great Britin, SE5 9RS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Referred to a specific hospital for treatment

Other

To King Saud University Dental College, treatment will be provided free of charge to the referred participants.

Other names: Interventional group

Primary outcomes

  1. change in the number of decayed teeth (untreated caries)

    Time frame: 12 months

    the change in the number of decayed teeth (untreated caries) in both primary and permanent teeth 12 months after intervention.

Secondary outcomes

  1. Changes in the proportion of children with untreated caries and whether the child visited the dentist

    Time frame: 12 months

    The change in the proportion of children with untreated caries in both deciduous and permanent teeth and whether the child visited the dentist

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • King Saud University

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Nov 17, 2017
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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