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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05772962
Other study ID # Children at risk
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 5, 2024
Est. completion date December 31, 2026

Study information

Verified date March 2023
Source Oral Health Centre of Expertise in Western Norway
Contact Ingfrid Vaksdal Brattabø, PhD
Phone +47 92487155
Email ingfrid.vaksdal.brattabo@vlfk.no
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2400
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Norway Oral Health Centre of Expertice Western Norway Bergen Vestland

Sponsors (4)

Lead Sponsor Collaborator
Oral Health Centre of Expertise in Western Norway Childrens advocacy center Bergen Norway, Oral Health Center of Expertise Rogaland, Norway, The public dental health service Vestland Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oral health and history Assess if there are differences in oral health and history between children enrolled at CAC and the control group 2022-2024
Secondary Need for facilitated dental treatment and follow up in the PDHS 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
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