Clinical trial NCT02487043: A Telephone-based Case-management Intervention for Caries Prevention in Children With Severe Early Childhood Caries
Official title: A Telephone-based Case-management Intervention for Caries Prevention in Children With Severe Early Childhood Caries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Childhood Caries
Keywords: Caries prevention
Early Childhood Caries
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Eastmaninstitutet
First posted: 2015-07-01
Enrollment: 151
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change from baseline in New carious lesion (decayed surfaces and decayed teeth) at 12 and 24 months
timeFrame: 12 months, 24 months
Secondary outcomes:
measure: Dental attendance
timeFrame: 12 months
measure: oral health related quality of life
timeFrame: 12 months
measure: Dental Anxiety among parents
timeFrame: 12 months
measure: Parental Stress
timeFrame: 12 months
measure: Dental beliefs among parents
timeFrame: 12 months
Other outcomes:
measure: Dental health coaches' experiences of their role
timeFrame: 18 months
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Huddinge
Study officials:
affiliation: Karolinska Institutet
name: Göran Dahllöf, Professor
role: PRINCIPAL_INVESTIGATOR
References: