Clinical trial NCT03345680: Examining the Impact of School-based Dental 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Dental visits
School-based program
Dental screening
Dental Caries
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: King Saud University
First posted: 2017-11-17
Enrollment: 996
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in the number of decayed teeth (untreated caries)
timeFrame: 12 months
Secondary outcomes:
measure: Changes in the proportion of children with untreated caries and whether the child visited the dentist
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
state: Great Britin
Study officials:
affiliation: King's College London
name: Haya M Alayadi, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Wael Sabbah, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.