Clinical trial NCT05772962: Children At Risk and Oral Health, the Dental Record Study
Official title: Children At Risk and Oral Health, the Dental Record Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Child Abuse
Child Neglect
Child Maltreatment
Keywords: Oral health
Dental health service
Childrens advocacy center
Prevention
Detection
Collaboration
Lead sponsor: Oral Health Centre of Expertise in Western Norway
Sponsor class: OTHER
Collaborators: name: Childrens advocacy center Bergen Norway
name: The public dental health service Vestland Norway
name: Oral Health Center of Expertise Rogaland, Norway
First posted: 2023-03-17
Enrollment: 2400
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children being between 0-18 years old at the time they are enrolled at CAC, and a matched controllgroup.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oral health and history
timeFrame: 2022-2024
Secondary outcomes:
measure: Need for facilitated dental treatment and follow up in the PDHS
timeFrame: 2022-2024
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Oral Health Centre of Expertice Western Norway
state: Vestland
Study officials:
affiliation: Oral Health Centre of Expertice, Western Norway
name: Ingfrid Vaksdal Brattabø, PhD
role: PRINCIPAL_INVESTIGATOR
References: