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Examining the Impact of School-based Dental Screening

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Referred to a specific hospital for treatment
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Dental Caries focused on measuring Dental visits, School-based program, Dental screening, Dental Caries

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • King's College London

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Interventional Group

Arm Description

Children will be screened, both parents and children will be informed of any abnormalities in the mouth.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in the proportion of children with untreated caries and whether the child visited the dentist
The change in the proportion of children with untreated caries in both deciduous and permanent teeth and whether the child visited the dentist

Full Information

First Posted
November 6, 2017
Last Updated
February 11, 2021
Sponsor
King's College London
Collaborators
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT03345680
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental visits, School-based program, Dental screening, Dental Caries

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
996 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Children will be screened, both parents and children will be informed of any abnormalities in the mouth.
Arm Title
Interventional Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Referred to a specific hospital for treatment
Other Intervention Name(s)
Interventional group
Intervention Description
To King Saud University Dental College, treatment will be provided free of charge to the referred participants.
Primary Outcome Measure Information:
Title
change in the number of decayed teeth (untreated caries)
Description
the change in the number of decayed teeth (untreated caries) in both primary and permanent teeth 12 months after intervention.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in the proportion of children with untreated caries and whether the child visited the dentist
Description
The change in the proportion of children with untreated caries in both deciduous and permanent teeth and whether the child visited the dentist
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haya M Alayadi, MSc
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wael Sabbah, PhD
Organizational Affiliation
King's College London
Official's Role
Study Director
Facility Information:
Facility Name
King's College London
City
London
State/Province
Great Britin
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
data will not be shared except to central participant and principal investigator
Citations:
PubMed Identifier
35894680
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.
Results Reference
derived
PubMed Identifier
29653545
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.
Results Reference
derived

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Examining the Impact of School-based Dental Screening

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