Back to resultsThe Impact of School Teachers in Care Navigation and Signposting Dental Caries in Primary School Children
Primary Purpose
Dental Caries in Children
Status
Completed
Phase
Not Applicable
Locations
Sudan
Study Type
Interventional
Intervention
Signpost caries
Sponsored by
About this trial
This is an interventional diagnostic trial for Dental Caries in Children
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
Sites / Locations
- Khartoum Centre for Research and Medical Training
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Care Navigation group
No internvention
Arm Description
The teachers will signpost dental caries based on ICCMS visual criteria and refer to the nearest service. Annual monitoring of caries
Caries experience (dmft) activity monitored annually
Outcomes
Primary Outcome Measures
untreated caries increment
decay component of the Index of decayed, extracted and filled teeth for the groups (deft)
Secondary Outcome Measures
caries experience (deft)
deft index (for entire group)
caries experience for the most affected one third (SIC index)
SIC index (deft of the most affected one third of each group)
care index
proportion of filled and extracted teeth (df/deft)
Full Information
NCT ID
NCT04945252
First Posted
June 25, 2021
Last Updated
July 11, 2021
Sponsor
Khartoum Centre for Research and Medical Training
1. Study Identification
Unique Protocol Identification Number
NCT04945252
Brief Title
The Impact of School Teachers in Care Navigation and Signposting Dental Caries in Primary School Children
Official Title
The Impact of School Teachers in Care Navigation and Signposting Dental Caries
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 19, 2016 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
March 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khartoum Centre for Research and Medical Training
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
non-randomized parallel design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
307 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Care Navigation group
Arm Type
Experimental
Arm Description
The teachers will signpost dental caries based on ICCMS visual criteria and refer to the nearest service. Annual monitoring of caries
Arm Title
No internvention
Arm Type
No Intervention
Arm Description
Caries experience (dmft) activity monitored annually
Intervention Type
Diagnostic Test
Intervention Name(s)
Signpost caries
Other Intervention Name(s)
signpost dental caries
Intervention Description
Identify carious lesion according to ICCMS visual criteria
Primary Outcome Measure Information:
Title
untreated caries increment
Description
decay component of the Index of decayed, extracted and filled teeth for the groups (deft)
Time Frame
36 months
Secondary Outcome Measure Information:
Title
caries experience (deft)
Description
deft index (for entire group)
Time Frame
36 months
Title
caries experience for the most affected one third (SIC index)
Description
SIC index (deft of the most affected one third of each group)
Time Frame
36 months
Title
care index
Description
proportion of filled and extracted teeth (df/deft)
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Khartoum Centre for Research and Medical Training
City
Khartoum
ZIP/Postal Code
11111
Country
Sudan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Impact of School Teachers in Care Navigation and Signposting Dental Caries in Primary School Children
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