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Examining the Impact of School-based Dental Screening

Sponsor
King's College London (Other)
Overall Status
Completed
CT.gov ID
NCT03345680
Collaborator
King Saud University (Other)
996
Enrollment
1
Location
2
Arms
26.7
Actual Duration (Months)
37.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Referred to a specific hospital for treatment
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
996 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Screening
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
Actual Study Start Date :
Oct 10, 2017
Actual Primary Completion Date :
Dec 30, 2018
Actual Study Completion Date :
Jan 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change in the number of decayed teeth (untreated caries) [12 months]

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

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 King's College London London Great Britin United Kingdom SE5 9RS

    Sponsors and Collaborators

    • King's College London
    • King Saud University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    King's College London
    ClinicalTrials.gov Identifier:
    NCT03345680
    Other Study ID Numbers:
    • HR-16/17-4683
    First Posted:
    Nov 17, 2017
    Last Update Posted:
    Feb 12, 2021
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by King's College London
    Dental visits
    School-based program
    Dental screening
    Dental Caries
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Feb 12, 2021