Examining the Impact of School-based Dental Screening

February 11, 2021 updated by: King's College London

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

996

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Great Britin
      • London, Great Britin, United Kingdom, SE5 9RS
        • King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Children will be screened, both parents and children will be informed of any abnormalities in the mouth.
Experimental: Interventional Group
Interventional (Dental Screening) Children will be screened for dental caries and referred to a specific hospital for treatment, namely King Saud University Dental College, treatment will be provided free of charge to the referred participants.
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.
Other Names:
  • Interventional group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

King Saud University

Investigators

  • Principal Investigator: Haya M Alayadi, MSc, King's College London
  • Study Director: Wael Sabbah, PhD, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2017

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

November 6, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

February 12, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-16/17-4683

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data will not be shared except to central participant and principal investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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