Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
996 participants
INTERVENTIONAL
2017-10-10
2020-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Control Group
Children will be screened, both parents and children will be informed of any abnormalities in the mouth.
No interventions assigned to this group
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.
Referred to a specific hospital for treatment
To King Saud University Dental College, treatment will be provided free of charge to the referred participants.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Both Saudis and non-Saudis.
* Children for whom the person with parental responsibility has signed the consent form
Exclusion Criteria
* 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.
6 Years
12 Years
ALL
Yes
Sponsors
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King Saud University
OTHER
King's College London
OTHER
Responsible Party
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Principal Investigators
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Haya M Alayadi, MSc
Role: PRINCIPAL_INVESTIGATOR
King's College London
Wael Sabbah, PhD
Role: STUDY_DIRECTOR
King's College London
Locations
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King's College London
London, Great Britin, United Kingdom
Countries
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References
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Arora A, Kumbargere Nagraj S, Khattri S, Ismail NM, Eachempati P. School dental screening programmes for oral health. Cochrane Database Syst Rev. 2022 Jul 27;7(7):CD012595. doi: 10.1002/14651858.CD012595.pub4.
Alayadi H, Sabbah W, Bernabe E. Effectiveness of school dental screening on dental visits and untreated caries among primary schoolchildren: study protocol for a cluster randomised controlled trial. Trials. 2018 Apr 13;19(1):224. doi: 10.1186/s13063-018-2619-2.
Other Identifiers
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HR-16/17-4683
Identifier Type: -
Identifier Source: org_study_id
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