Examining the Impact of School-based Dental Screening

NCT ID: NCT03345680

Last Updated: 2021-02-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

996 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-10

Study Completion Date

2020-01-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

Referred to a specific hospital for treatment

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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Interventional group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King Saud University

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United Kingdom

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.

Reference Type DERIVED
PMID: 35894680 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29653545 (View on PubMed)

Other Identifiers

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HR-16/17-4683

Identifier Type: -

Identifier Source: org_study_id

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