NCT03345680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
996

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2017

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 12, 2021

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

November 6, 2017

Last Update Submit

February 11, 2021

Conditions

Dental Caries

Keywords

Dental visitsSchool-based programDental screeningDental Caries

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

  • Changes in the proportion of children with untreated caries and whether the child visited the dentist

    12 months

Study Arms (2)

Control Group

NO INTERVENTION

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

Interventional Group

EXPERIMENTAL

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

Interventions

Referred to a specific hospital for treatmentOTHER

To King Saud University Dental College, treatment will be provided free of charge to the referred participants.

Also known as: Interventional group
Interventional Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, Great Britin, SE5 9RS, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 35894680DERIVED

  • 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.

    PMID: 29653545DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Haya M Alayadi, MSc

    King's College London

    PRINCIPAL INVESTIGATOR

  • Wael Sabbah, PhD

    King's College London

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 17, 2017

Study Start

October 10, 2017

Primary Completion

December 30, 2018

Study Completion

January 1, 2020

Last Updated

February 12, 2021

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

data will not be shared except to central participant and principal investigator

Locations

GB(1)