An interventional study of A telephone-based case-management intervention in Early Childhood Caries, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged Up to 6 Years. Per ClinicalTrials.gov, last updated 2022-11-25.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention
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.
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.
Karolinska Institutet is the lead sponsor of 1,146 studies on the registry; 275 are open to participants now.
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Exclusion Criteria:
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
Conventional protocol (Fluoride prevention program) and follow-up as usual
Regular Telephone support delivered by Health coaches
Change from baseline in New carious lesion (decayed surfaces and decayed teeth) at 12 and 24 months
decayed surfaces (dmfs) and decayed teeth (dmft)
Time frame: 12 months, 24 months
Dental attendance
number of visits to dental health care during the observation period, number of unscheduled appointments, number of missed and cancelled appointments
Time frame: 12 months
oral health related quality of life
Validated scale OHRQoL, subscales FIS and P-CPQ will be used
Time frame: 12 months
Dental Anxiety among parents
Dental Anxiety Scale, DAS
Time frame: 12 months
Parental Stress
The Swedish Parenthood Stress Questionnaire - SPSQ
Time frame: 12 months
Dental beliefs among parents
Swedish version of the revised Dental Beliefs Survey (DBS-R)
Time frame: 12 months
Dental health coaches' experiences of their role
Questioners and focus groups will be used to understand the experience of the health coach in order to refine the intervention in future projects
Time frame: 18 months
Plan to share: No — Data collected only for this study
Ran from Aug 2015 to primary completion in Jan 2021, 65 months.
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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