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

Sponsor
Karolinska Institutet (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02487043
Collaborator
Eastmaninstitutet, Pediatric Dentistry, Public Dental Service Stockholm, Sweden (Other)
151
1
2
87
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: A telephone-based case-management intervention
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
151 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Telephone-based Case-management Intervention for Caries Prevention in Children With Severe Early Childhood Caries
Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

Behavioral: A telephone-based case-management intervention
Regular Telephone support delivered by Health coaches

No Intervention: Control group

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in New carious lesion (decayed surfaces and decayed teeth) at 12 and 24 months [12 months, 24 months]

    decayed surfaces (dmfs) and decayed teeth (dmft)

Secondary Outcome Measures

  1. Dental attendance [12 months]

    number of visits to dental health care during the observation period, number of unscheduled appointments, number of missed and cancelled appointments

  2. oral health related quality of life [12 months]

    Validated scale OHRQoL, subscales FIS and P-CPQ will be used

  3. Dental Anxiety among parents [12 months]

    Dental Anxiety Scale, DAS

  4. Parental Stress [12 months]

    The Swedish Parenthood Stress Questionnaire - SPSQ

  5. Dental beliefs among parents [12 months]

    Swedish version of the revised Dental Beliefs Survey (DBS-R)

Other Outcome Measures

  1. Dental health coaches' experiences of their role [18 months]

    Questioners and focus groups will be used to understand the experience of the health coach in order to refine the intervention in future projects

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska Institutet Stockholm Huddinge Sweden 141 04

Sponsors and Collaborators

  • Karolinska Institutet
  • Eastmaninstitutet, Pediatric Dentistry, Public Dental Service Stockholm, Sweden

Investigators

  • Principal Investigator: Göran Dahllöf, Professor, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Göran Dahllöf, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02487043
Other Study ID Numbers:
  • Dnr 1-314/2013 SOF, KI
First Posted:
Jul 1, 2015
Last Update Posted:
Sep 8, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Göran Dahllöf, Professor, Karolinska Institutet

Study Results

No Results Posted as of Sep 8, 2021