- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04945252
The Impact of School Teachers in Care Navigation and Signposting Dental Caries in Primary School Children
July 11, 2021 updated by: Fadil Elamin, Khartoum Centre for Research and Medical Training
The Impact of School Teachers in Care Navigation and Signposting Dental Caries
The study aims to investigate the role of school teachers in care navigation and signposting dental caries in primary school children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
307
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Khartoum, Sudan, 11111
- Khartoum Centre for Research and Medical Training
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Care Navigation group
The teachers will signpost dental caries based on ICCMS visual criteria and refer to the nearest service.
Annual monitoring of caries
|
Identify carious lesion according to ICCMS visual criteria
Other Names:
|
No Intervention: No internvention
Caries experience (dmft) activity monitored annually
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
untreated caries increment
Time Frame: 36 months
|
decay component of the Index of decayed, extracted and filled teeth for the groups (deft)
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
caries experience (deft)
Time Frame: 36 months
|
deft index (for entire group)
|
36 months
|
caries experience for the most affected one third (SIC index)
Time Frame: 36 months
|
SIC index (deft of the most affected one third of each group)
|
36 months
|
care index
Time Frame: 36 months
|
proportion of filled and extracted teeth (df/deft)
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 19, 2016
Primary Completion (Actual)
June 20, 2019
Study Completion (Actual)
March 11, 2020
Study Registration Dates
First Submitted
June 25, 2021
First Submitted That Met QC Criteria
June 25, 2021
First Posted (Actual)
June 30, 2021
Study Record Updates
Last Update Posted (Actual)
July 15, 2021
Last Update Submitted That Met QC Criteria
July 11, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Khrt02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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