Early Childhood CariesNCT02487043
A Telephone-based Case-management Intervention for Caries Prevention in Children With Severe Early Childhood Caries
A study testing A telephone-based case-management intervention in people with Early Childhood Caries, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- A telephone-based case-management intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2015to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pre-school children < 6 years of age
- Severe childhood caries
- treated under general anesthesia in Stockholm County Council during a one year period.
Who cannot join
- Medically compromised children
- Children with learning disabilities
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Early Childhood Caries
- Being tested
- A telephone-based case-management intervention
- Keywords
- Caries prevention, Early Childhood Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A telephone-based case-management interventionBehavioural
Regular Telephone support delivered by Health coaches
| Study group | Role | What they receive |
|---|---|---|
| Dental health coaches | Experimental | 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) Receives: Behavioral: A telephone-based case-management intervention |
| Control group | No intervention | Conventional protocol (Fluoride prevention program) and follow-up as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in New carious lesion (decayed surfaces and decayed teeth) at 12 and 24 months
decayed surfaces (dmfs) and decayed teeth (dmft)
Measured: 12 months, 24 months
Secondary outcomes (5)
Dental attendance
number of visits to dental health care during the observation period, number of unscheduled appointments, number of missed and cancelled appointments
Measured: 12 months
oral health related quality of life
Validated scale OHRQoL, subscales FIS and P-CPQ will be used
Measured: 12 months
Dental Anxiety among parents
Dental Anxiety Scale, DAS
Measured: 12 months
Parental Stress
The Swedish Parenthood Stress Questionnaire - SPSQ
Measured: 12 months
Dental beliefs among parents
Swedish version of the revised Dental Beliefs Survey (DBS-R)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2021
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Eastmaninstitutet
- Responsible party
- Principal investigator, Göran Dahllöf, Karolinska Institutet
- Investigators
- Göran Dahllöf, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487043
- Sponsor's protocol ID
- Dnr 1-314/2013 SOF, KI
- Status last verified
- Nov 2022
- First submitted
- 24 Jun 2015
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data collected only for this study
Publications
Brannemo I, Levinsson A, Hasselblad T, Dahllof G, Tsilingaridis G. Parental psychosocial factors and children's oral health-related quality of life: Data from a caries prevention study with phone-based support. BMC Oral Health. 2025 Jan 18;25(1):94. doi: 10.1186/s12903-025-05446-z.
PubMed 39827351
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telephone-based Case-management Intervention for Caries Prevention in Children With Severe Early Childhood Caries
- ClinicalTrials.gov ID
- NCT02487043
- Acronym / sponsor ID
- Dnr 1-314/2013 SOF, KI
- Conditions
- Early Childhood Caries
- Keywords
- Caries prevention, Early Childhood Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Eastmaninstitutet
- Study start
- Aug 2015 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental health coaches | Experimental | Behavioral: A telephone-based case-management interventionTelephone-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) |
| Control group | No intervention | –Conventional protocol (Fluoride prevention program) and follow-up as usual |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pre-school children < 6 years of age
- Severe childhood caries
- treated under general anesthesia in Stockholm County Council during a one year period.
Key exclusion criteria (2 listed)
- Medically compromised children
- Children with learning disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A telephone-based case-management interventionRegular Telephone support delivered by Health coaches | Behavioural | Dental health coaches |
Primary outcome
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)
5 secondary outcomes
Dental attendance
Time frame: 12 months
oral health related quality of life
Time frame: 12 months
Dental Anxiety among parents
Time frame: 12 months
Parental Stress
Time frame: 12 months
Dental beliefs among parents
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Derived from this study: PubMed 39827351Brannemo I, Levinsson A, Hasselblad T, Dahllof G, Tsilingaridis G. Parental psychosocial factors and children's oral health-related quality of life: Data from a caries prevention study with phone-based support. BMC Oral Health. 2025 Jan 18;25(1):94. doi: 10.1186/s12903-025-05446-z.
- Individual participant dataSharing planned: No. Data collected only for this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Göran Dahllöf, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A telephone-based case-management intervention in people with Early Childhood Caries, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in New carious lesion (decayed surfaces and decayed teeth) at 12 and 24 months (time frame: 12 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02487043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.