A Telephone-based Case-management Intervention for Caries Prevention in Children With Severe Early Childhood Caries

NCT ID: NCT02487043

Last Updated: 2022-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2021-10-31

Brief Summary

Despite improvements in oral health among children, children living in areas characterized by low socio-economic status still have a significant disease burden with regard to dental caries. Special efforts to prevent disease development in this group of children have been unsuccessful. Small children with extensive treatment needs often have limited abilities to cooperate and to provide quality dental care in this patient group, general aneaethesia (GA) may often be the treatment modality of choice. Preschool children treated under general anesthesia have significantly higher caries prevalence (deft and defs), apical parodontitis and infection due to pulpal necrosis. They also have significantly more emergency visits and previous use of treatment under sedation.

This study aim to test the hypothesis, that a telephone based case management intervention for children with severe early childhood caries can prevent further caries development in preschool children who are treated under general anesthesia for severe early childhood caries.

Detailed Description

Consecutive children (n=130) who are referred to the departments of pediatric dentistry at Eastman Dental Institute, Public Dental Service and Dental Medicine, Karolinska Institutet, who fulfill inclusion criteria are invited to participate in the study. This is done during the visits preceding the anesthetic evaluation of the patient. Parents will be given written information about the study. During the last visit preceding the GA, a contact is established between dental health coach and family. During this visit the aim of the project is explained and an agreement is signed and informed consent is obtained from the parents only (the parents are the target for this intervention, it is they who perform the preventive oral health measures and supports the child). During this interview, the parents will also answer a structured interview measuring level of self-efficacy and well as their thoughts on dental health care as well as why the situation has occurred. After the initial interview patients are assigned to either intervention group (dental health coach group) or to a control group.

The dental healthcoach will keep in close contact with the intervention group, and by telephone based support provide information, support parental self-efficacy, motivate the family to keep preventive measures that have been individually agreed on, motivate parents to keep preventive appointments and to provide tools for caries prevention.

A follow-up visit is scheduled after 1 year. Parents who decline participation in the program will receive treatment as usual and will be followed for 1 year.

Patients in the control group will receive treatment as usual. This means recall visits to the dental clinic within 3 months after the procedure, reinforcing the individually tailored preventive program. Recall visits after that are scheduled based on treatment needs. A follow-up visit is scheduled after 1 year.

Caries will be diagnosed at baseline ( during GA) and progression will be monitored according to ICDAS after 12 and 24 months. Plaque and gingivitis will be registered.

Conditions

Early Childhood Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Dental health coaches

Telephone-based case-management intervention. Contact with families every 2 weeks during one year. Including motivational interviewing, support for dental preventive measures at home, answer questions, care coordination) + conventional protocol (Fluoride prevention program)

Group Type: EXPERIMENTAL

A telephone-based case-management intervention

Intervention Type: BEHAVIORAL

Regular Telephone support delivered by Health coaches

Control group

Conventional protocol (Fluoride prevention program) and follow-up as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

A telephone-based case-management intervention

Regular Telephone support delivered by Health coaches

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Pre-school children < 6 years of age
• Severe childhood caries
• treated under general anesthesia in Stockholm County Council during a one year period.

Exclusion Criteria

• Medically compromised children
• Children with learning disabilities

• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastmaninstitutet

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Göran Dahllöf

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Göran Dahllöf, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet

Stockholm, Huddinge, Sweden

Countries

Sweden

References

Brannemo I, Levinsson A, Hasselblad T, Dahllof G, Tsilingaridis G. Parental psychosocial factors and children's oral health-related quality of life: Data from a caries prevention study with phone-based support. BMC Oral Health. 2025 Jan 18;25(1):94. doi: 10.1186/s12903-025-05446-z.

Reference Type: DERIVED

PMID: 39827351 (View on PubMed)

Other Identifiers

Dnr 1-314/2013 SOF, KI

Identifier Type: -

Identifier Source: org_study_id