NCT04945252

Brief Summary

The study aims to investigate the role of school teachers in care navigation and signposting dental caries in primary school children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
307

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

3 years

First QC Date

June 25, 2021

Last Update Submit

July 11, 2021

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

  • untreated caries increment

    decay component of the Index of decayed, extracted and filled teeth for the groups (deft)

    36 months

Secondary Outcomes (3)

  • caries experience (deft)

    36 months

  • caries experience for the most affected one third (SIC index)

    36 months

  • care index

    36 months

Study Arms (2)

Care Navigation group

EXPERIMENTAL

The teachers will signpost dental caries based on ICCMS visual criteria and refer to the nearest service. Annual monitoring of caries

Diagnostic Test: Signpost caries

No internvention

NO INTERVENTION

Caries experience (dmft) activity monitored annually

Interventions

Signpost cariesDIAGNOSTIC_TEST

Identify carious lesion according to ICCMS visual criteria

Also known as: signpost dental caries
Care Navigation group

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy school children between the ages of 5-8 years Regular school attender Lives in the local village Co-operative

You may not qualify if:

  • known medical history or disability
  • irregular school attenders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khartoum Centre for Research and Medical Training

Khartoum, 11111, Sudan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: non-randomized parallel design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 25, 2021

First Posted

June 30, 2021

Study Start

June 19, 2016

Primary Completion

June 20, 2019

Study Completion

March 11, 2020

Last Updated

July 15, 2021

Record last verified: 2021-07

Locations

SU(1)