- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05772962
Children at Risk and Oral Health, The Dental Record Study
The objectives of this retrospective dental record study, are to increase knowledge of the oral health, - history and -needs of children enrolled at the Childrens Advocacy Centers (CAC)by:
- assessing if it is possible to identify oral indicators of child maltreatment.
- assessing if and to what degree the children enrolled at CAC are in need of close, adapted and trauma sensitive treatment and follow up at the Public Dental Health Service (PDHS)
- assessing if there is a need for new routines in terms of interdisciplinary collaboration and sharing of information between CAC, Child Welfare Services (CWS) and PDHP.
By increasing knowledge in regard to child maltreatment and oral health, the study will raise PDHS and CAC ability to prevent, detect and help children being victims of maltreatment, and contribute to strengthen PDHS, CAC and CWS interdisciplinary interaction for the benefit of children at risk.
Study Overview
Status
Conditions
Detailed Description
The combination of the CAC and the organization of the PDHS in Norway with regular summoning of all children up to 18 years, provides a unique opportunity to identify children at risk and study their oral health and history in a retrospective perspective. Retrospective dental record data will be collected from the public dental health records of children, aged 0-18 when enrolled at CAC, and a control group matched by gender and age.
In addition to increase knowledge of the oral health, and - history, the dental record data will also provide information regarding the PDHS 's ability to detect, follow up and interact with children at risk and to which degree interdisciplinary cooperation between the CAC, the child welfare service and the PDHS takes place and are functioning.
By using already existing data from the childrens dental records at the public dental health service the study will gain new and important knowledge, without adding further burden to the children and families.
The Ethical committee REK Vest, has approved the study and permitted that the study will be conducted without an informed consent from the parents and children being enrolled. In order to secure that the research project is in line with General Data Protection Regulation (GDPR), identify, evaluate and negating the risks of the personal data being collected, A Data Protection Impact Assessment (DPIA) has been conducted.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ingfrid Vaksdal Brattabø, PhD
- Phone Number: +47 92487155
- Email: ingfrid.vaksdal.brattabo@vlfk.no
Study Contact Backup
- Name: Karin Goplerud Berge, PhD
- Email: karin.goplerud.berge@vlfk.no
Study Locations
-
-
Vestland
-
Bergen, Vestland, Norway, 5865
- Recruiting
- Oral Health Centre of Expertice Western Norway
-
Contact:
- Ingfrid V Brattabø, PhD
- Phone Number: +47 92487155
- Email: ingfrid.vaksdal.brattabo@vlfk.no
-
Contact:
- Karin G Berge, PhD
- Phone Number: +47 98407778
- Email: karin.goplerud.berge@vlfk.no
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children enrolled at CAC
- Control group matched by age and gender
Exclusion Criteria:
- Children with developmental disorders that affect oral health
- Children with mental retardation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Children enrolled at CAC
Information regarding oral health will be gathered from the public dental health records of children enrolled at CAC.
|
|
Children not enrolled at CAC
Information regarding oral health will be gathered from the public dental health records of children that have not been enrolled at CAC.
This is a control group, matched by age and gender.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral health and history
Time Frame: 2022-2024
|
Assess if there are differences in oral health and history between children enrolled at CAC and the control group
|
2022-2024
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Need for facilitated dental treatment and follow up in the PDHS
Time Frame: 2022-2024
|
Assess if and which needs children have is in regard to oral health, facilitated dental treatment in the PDHS, interdisciplinary collaboration and follow up.
Are there differences between the two groups?
|
2022-2024
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ingfrid Vaksdal Brattabø, PhD, Oral Health Centre of Expertice, Western Norway
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Children at risk
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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