Children at Risk and Oral Health, The Dental Record Study

Child Abuse Clinical Trial

Official title:

Children at Risk and Oral Health, The Dental Record Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772962
• Other study ID #: Children at risk
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Child Abuse
• Child Maltreatment
• Child Neglect

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