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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02487043
Recruitment Status : Recruiting
First Posted : July 1, 2015
Last Update Posted : January 30, 2019
Eastmaninstitutet, Pediatric Dentistry, Public Dental Service Stockholm, Sweden
Information provided by (Responsible Party):
Göran Dahllöf, Karolinska Institutet

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
Early Childhood Caries Behavioral: A telephone-based case-management intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 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 : August 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

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

Primary Outcome Measures :
  1. Change from baseline in New carious lesion (decayed surfaces and decayed teeth) at 12 and 24 months [ Time Frame: 12 months, 24 months ]
    decayed surfaces (dmfs) and decayed teeth (dmft)

Secondary Outcome Measures :
  1. Dental attendance [ Time Frame: 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 [ Time Frame: 12 months ]
    Validated scale OHRQoL, subscales FIS and P-CPQ will be used

  3. Dental Anxiety among parents [ Time Frame: 12 months ]
    Dental Anxiety Scale, DAS

  4. Parental Stress [ Time Frame: 12 months ]
    The Swedish Parenthood Stress Questionnaire - SPSQ

  5. Dental beliefs among parents [ Time Frame: 12 months ]
    Swedish version of the revised Dental Beliefs Survey (DBS-R)

Other Outcome Measures:
  1. Dental health coaches' experiences of their role [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02487043

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Contact: Georgios Tsilingaridis, Med dr +46-8-12316540/41
Contact: Ida Brännemo, PhD +46-8-524 880 39

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Karolinska Institutet Recruiting
Stockholm, Huddinge, Sweden, 141 04
Contact: Georgios Tsilingaridis, Med dr   
Contact: Ida Brännemo, PhD   
Sponsors and Collaborators
Karolinska Institutet
Eastmaninstitutet, Pediatric Dentistry, Public Dental Service Stockholm, Sweden
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Principal Investigator: Göran Dahllöf, Professor Karolinska Institutet

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Responsible Party: Göran Dahllöf, Professor, Karolinska Institutet Identifier: NCT02487043     History of Changes
Other Study ID Numbers: Dnr 1-314/2013 SOF, KI
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data collected only for this study

Keywords provided by Göran Dahllöf, Karolinska Institutet:
Caries prevention
Early Childhood Caries