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Examining the Impact of School-based Dental Screening

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ClinicalTrials.gov Identifier: NCT03345680
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
King Saud University
Information provided by (Responsible Party):
King's College London

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
Dental Caries Other: Referred to a specific hospital for treatment Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 1000 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 : October 10, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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 Name: Interventional group




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345680


Contacts
Contact: Haya M Alayadi, MSc 00447476707407 haya.alayadi@kcl.ac.uk
Contact: Wael Sabbah, PhD 020 3299 3272 wael.sabbah@kcl.ac.uk

Locations
United Kingdom
King's College London Recruiting
London, Great Britin, United Kingdom, SE5 9RS
Contact: Haya Alayadi, MSc    020 3299 3272    haya.alayadi@kcl.ac.uk   
Contact: Wael Sabbah, PhD    020 3299 3272    wael.sabbah@kcl.ac.uk   
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03345680     History of Changes
Other Study ID Numbers: HR-16/17-4683
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: data will not be shared except to central participant and principal investigator

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
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases