The Impact of School Teachers in Care Navigation and Sign... | NCT04945252

Studies
The Impact of School Teachers in Care Navigation and Signposting Dental Caries in Primary School Children

NCT04945252

Sponsor

Khartoum Centre for Research and Medical Training

Status

Completed

Last Update Posted

Jul 15, 2021Actual

Enrollment

307Actual

Phase

Not Applicable

Conditions

Dental Caries in Children

Interventions

Signpost caries

Countries

Sudan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 19, 2016Actual

Primary Completion Date

Jun 20, 2019Actual

Completion Date

Mar 11, 2020Actual

First Submitted Date

Jun 25, 2021

First Submission Date that Met QC Criteria

Jun 25, 2021

First Posted Date

Jun 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2021

Last Update Posted Date

Jul 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fadil Elamin, Doctor, Khartoum Centre for Research and Medical TrainingPrincipal Investigator

Lead Sponsor

Khartoum Centre for Research and Medical TrainingOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Dental caries is a multifactorial disease with high prevalence in children. Dental caries is a global public health problem with detrimental impact in developing countries. Despite advances in caries management and detection poorer countries continue to suffer a high burden of disease. Advances in care navigation and sign-posting concepts are increasingly being utilized in general health care to aid early diagnosis and ease the burden of disease in poorer communities. This study aims to investigate the role of primary school teachers as care navigators with regard to dental caries in children.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

307Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Signpost caries	Diagnostic Test	Identify carious lesion according to ICCMS visual criteria	Care Navigation group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
untreated caries increment	decay component of the Index of decayed, extracted and filled teeth for the groups (deft)	36 months

Secondary Outcomes

Measure	Description	Time Frame
caries experience (deft)	deft index (for entire group)	36 months
caries experience for the most affected one third (SIC index)	SIC index (deft of the most affected one third of each group)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

known medical history or disability
irregular school attenders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Khartoum Centre for Research and Medical Training		Khartoum		11111	Sudan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided