Dental Caries in ChildrenNCT04945252
The Impact of School Teachers in Care Navigation and Signposting Dental Caries in Primary School Children
A study testing Signpost caries in people with Dental Caries in Children, run by Khartoum Centre for Research and Medical Training at 1 site in Sudan.
Trial summary
The study aims to investigate the role of school teachers in care navigation and signposting dental caries in primary school children. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Signpost caries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 siteSudan
- Study dates
- 19 Jun 2016to 11 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy school children between the ages of 5-8 years Regular school attender Lives in the local village Co-operative
Who cannot join
- known medical history or disability
- irregular school attenders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Caries in Children
- Being tested
- Signpost caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signpost cariesDiagnostic test
Also called signpost dental caries
Identify carious lesion according to ICCMS visual criteria
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Signpost caries |
| No internvention | No intervention | Caries experience (dmft) activity monitored annually |
What is being measured
The primary outcome is the main question the study is designed to answer.
untreated caries increment
decay component of the Index of decayed, extracted and filled teeth for the groups (deft)
Measured: 36 months
Secondary outcomes (3)
caries experience (deft)
deft index (for entire group)
Measured: 36 months
caries experience for the most affected one third (SIC index)
SIC index (deft of the most affected one third of each group)
Measured: 36 months
care index
proportion of filled and extracted teeth (df/deft)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start19 Jun 2016
- Primary completion20 Jun 2019
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non-randomized parallel design
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khartoum Centre for Research and Medical Training
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadil Elamin, Khartoum Centre for Research and Medical Training
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945252
- Sponsor's protocol ID
- Khrt02
- Status last verified
- Jul 2021
- First submitted
- 25 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of School Teachers in Care Navigation and Signposting Dental Caries
- ClinicalTrials.gov ID
- NCT04945252
- Acronym / sponsor ID
- Khrt02
- Conditions
- Dental Caries in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Khartoum Centre for Research and Medical TrainingUniversity, hospital or other
- Study start
- 19 Jun 2016 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-randomized parallel design
| Arm | Type | Receives |
|---|---|---|
| Care Navigation group | Experimental | Diagnostic Test: Signpost cariesThe teachers will signpost dental caries based on ICCMS visual criteria and refer to the nearest service. Annual monitoring of caries |
| No internvention | No intervention | –Caries experience (dmft) activity monitored annually |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy school children between the ages of 5-8 years Regular school attender Lives in the local village Co-operative
Key exclusion criteria (2 listed)
- known medical history or disability
- irregular school attenders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Signpost cariesAlso: signpost dental cariesIdentify carious lesion according to ICCMS visual criteria | Diagnostic test | Care Navigation group |
Primary outcome
untreated caries increment
Time frame: 36 months
decay component of the Index of decayed, extracted and filled teeth for the groups (deft)
3 secondary outcomes
caries experience (deft)
Time frame: 36 months
caries experience for the most affected one third (SIC index)
Time frame: 36 months
care index
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Signpost caries in people with Dental Caries in Children, run by Khartoum Centre for Research and Medical Training at 1 site in Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
untreated caries increment (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.