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

NCT02487043 | Completed

• 1 other identifier: Dnr 1-314/2013 SOF, KI
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Childhood Caries

Keywords

Caries prevention; Early Childhood Caries

Outcome Measures

Primary Outcomes (1)

• Change from baseline in New carious lesion (decayed surfaces and decayed teeth) at 12 and 24 months

  decayed surfaces (dmfs) and decayed teeth (dmft)

  12 months, 24 months

Secondary Outcomes (5)

• Dental attendance

  12 months

• oral health related quality of life

  12 months

• Dental Anxiety among parents

  12 months

• Parental Stress

  12 months

• Dental beliefs among parents

  12 months

Other Outcomes (1)

• Dental health coaches' experiences of their role

  18 months

Study Arms (2)

Dental health coaches

EXPERIMENTAL

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)

Behavioral: A telephone-based case-management intervention

Control group

NO INTERVENTION

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

Interventions

A telephone-based case-management intervention BEHAVIORAL

Regular Telephone support delivered by Health coaches

Dental health coaches

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Medically compromised children
• Children with learning disabilities

Sponsors & Collaborators

• Karolinska Institutet: lead
• Eastmaninstitutet: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Huddinge, 141 04, Sweden

Location

Related Publications (1)

• 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.

  PMID: 39827351 DERIVED

Study Officials

• Göran Dahllöf, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 1, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)