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NCT Number: NCT02487043

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

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.

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Key information

Conditions

Early Childhood Caries

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Huddinge, 141 04, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A telephone-based case-management intervention

Behavioral

Regular Telephone support delivered by Health coaches

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Eastmaninstitutet

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jul 1, 2015
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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