Children at Risk and Oral Health, The Dental Record Study

Sponsor

Oral Health Centre of Expertise in Western Norway (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05772962

Collaborator

Childrens advocacy center Bergen Norway (Other), The public dental health service Vestland Norway (Other), Oral Health Center of Expertise Rogaland, Norway (Other)

2,400

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Child Abuse Child Neglect Child Maltreatment

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 Design

Study Type:

Observational

Anticipated Enrollment :

2400 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Children at Risk and Oral Health, The Dental Record Study

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Oral health and history [2022-2024]
Assess if there are differences in oral health and history between children enrolled at CAC and the control group

Secondary Outcome Measures

Need for facilitated dental treatment and follow up in the PDHS [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?

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Principal Investigator: Ingfrid Vaksdal Brattabø, PhD, Oral Health Centre of Expertice, Western Norway

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oral Health Centre of Expertise in Western Norway

ClinicalTrials.gov Identifier:

NCT05772962

Other Study ID Numbers:

Children at risk

First Posted:

Mar 17, 2023

Last Update Posted:

Mar 17, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Oral Health Centre of Expertise in Western Norway

Oral health

Dental health service

Childrens advocacy center

Prevention

Detection

Collaboration

Study Results

No Results Posted as of Mar 17, 2023