Dental Caries in ChildrenEOHNCT04389905
Equal Oral Health in Children: The Hageby-model
A study testing Dental education - Motivational Interviewing in people with Dental Caries in Children and Economic Problems, run by Mats Bågesund at 1 site in Sweden.
Trial summary
Pregnant women - living in thecatchment area of a public dental clinic with known higher caries experience and generally lower socioeconomical status than at other dental clinics in the Region - are recruited for the study. Repeated information and surveys of dental knowledge, dental habits and medical conditions etc. Read more about this study
- Who is it for?
- Ages Up to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children, Economic Problems, Infant Conditions
- What is being tested?
- Dental education - Motivational Interviewing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 667 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2013to 17 Jun 2022
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Pregnant woman visiting maternal health care at the Vrinevi Hospital, Norrköping, for the current pregnancy during the time of the study.
- The expecting mother's accommodation - during the time of the study - is at an address within Hageby and Navestad (defined as associated socio-economic cluster status 5). (Socio-economic affiliation).
- The participating Child must be examined in the Public Dental Service at the 3- and 6-year examinations.
Who cannot join
- Other home address than mentionned above.
- Moved out of the area during the time of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Pregnant women - living in thecatchment area of a public dental clinic with known higher caries experience and generally lower socioeconomical status than at other dental clinics in the Region - are recruited for the study.
Repeated information and surveys of dental knowledge, dental habits and medical conditions etc. is sample.
Read more
Before birth, one month after birth, and 12 and 18 months after birth of the Child, the mother repeatedly answers questionnaires and recieves information about dental care.
At 18 months,and at the 3- and 6-year dental examinations the caries experience dmft/deft is registered.
All Children and accompanying parent receives an individual caries preventive program between the examinations.
Evaluation will be focused on possible caries sreduction and Health econimic aspects of the interventions.
Read the detailed description
- At the first visit to maternal health care: Preliminary caries risk assessment of the family using questionnaire 1 to the expectant mother and father / partner. The invitation and time are given for an initial health call. The invitation is translated into the most common languages in Hageby and Navestad. If a translation into the current language is missing, an interpreter is hired.
- During pregnancy: Health talk with specially trained dental hygienist / dental nurse at the local Public Dental Clinic (Folktandvården Hageby). Determination of the family's risk assessment in accordance with the criteria of the regional Public Dental Service in the County of Östergötland is adapted for the project.
- One-month monitoring in child health care: Follow-up of caries risk assessment of the family with the help of questionnaire 2 to future mother and father / partner.
- Care program 6-18 months with different designed depending on caries risk.
- At 12 months: Group information or individual call, depending on risk, in collaboration with child health care. Follow-up of the family's caries risk assessment with questionnaire 3 to the expectant mother and father / partner.
- At 18 months regardless of risk: Health talk, examination and renewed caries risk assessment of the child according to the criteria of the Public Dental Service.
- Dental care program 18-30 months, individually designed depending on caries risk evaluation: Oral health behavior is evaluated using a caries risk assessment questionnaire. The questions in the form are based on factors that are of importance for caries development, and are supplemented with information from the maternity care and social services medical records. The questionnaire is constructed with yes and no as a response alternative, where the no-answers, together with an assessment of a dietary registration, indicate an increased risk of developing caries. The questionnaire registers risk behavior as a point. The evaluation is conducted as an assessment of changed risk points. The baseline data uses the score from the first questionnaire to be answered during pregnancy, according to point 1 above in the dental care program. The questionnaire is constructed based on known risk factors for caries, but has not been validated for measuring oral health behavior. A validation is therefore planned to be implemented as part of the project and applied for separately. Caries prevalence is evaluated by routinely collected caries epidemiological data when the children are 3 and 6 years and reported as the proportion of caries-free children, average dmft (= caries, extracted and filled teeth) and proportion of children with deft> =5. Three and six years are so-called indicator ages for caries epidemiological records. This means that caries data at the personal number level for all children in Östergötland are reported to the County Council. Participation in the dental care program is reported as the proportion of pregnant women who participate in the first health call compared to the proportion of pregnant women in control group 1 who participate in maternal health care's regular parental education on oral health at the midwifery. The usefulness of the questionnaire as a screening instrument is evaluated by comparing the outcome of the risk assessment with the caries outcome when the children in the control group are 3 and 6 years, respectively. The health economic evaluation focuses on cost efficiency. All costs associated with the intervention are recorded and calculated. Effects are calculated in the form of the number of people who come to the health interviews and meetings, changes in behavior, and in the longer term the changes in the number of dmft that occur. Cost efficiency is therefore calculated as the extra cost incurred per extra power (e.g. cost per person coming or cost per prevented dmft). The evaluation mainly uses a socio-economic perspective, which means that all costs and effects that arise at different levels in society are taken into account.
- Conditions
- Dental Caries in Children, Economic Problems, Infant Conditions, Child, Preschool, Pregnancy Related, Educational Problems
- Being tested
- Dental education - Motivational Interviewing
- Keywords
- Dental Caries in Children, Pregnancy, Infant Conditions, Economic Problems, Child, Preschool, Health Education, Dental
- Medical subject headings
- Risk Reduction Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental education - Motivational InterviewingBehavioural
Also called Questionnaire
Motivational Interviewing - Focusing on oral/dental health
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing Oral Health Education Group | Experimental | The intervention group focused on the mothers from before birth until their child reached the age of 3 years. They received repeated questionnaires and repeated oral health education using the Motivational Interviewing (MI) technique. Receives: Behavioral: Dental education - Motivational Interviewing |
| Local Control Group | No intervention | The local control group included other mothers and their children, who were (randomized according to) born during the same time as the children in the intervention group. They received only a questionnaire before their children were born. Caries data from 3- and 6-year examination is used. |
| Similar Socio-economics Control Group | No intervention | This control group is from a Public Dental Clinic with similar socioeconomics (among the families in the catchment area of the clinic) as in the intervention group. This control group included mothers and their children, who were (randomized according to) born during the same time as the children in the intervention group. They received only a questionnaire before their children were born. Caries data from 3- and 6-year examination is used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Childhood Caries (ECC) experience/prevalence at 3-years age
Early Childhood Caries experience/prevalence (dmft/deft)
Measured: The outcome of ECC experience/prevalence is evaluated at 3-years age
Early Childhood Caries (ECC) experience/prevalence at 6-years age
Early Childhood Caries experience/prevalence (dmft/deft)
Measured: The outcome of ECC experience/prevalence is evaluated at 6-years age
Secondary outcomes (1)
Cost-benefit analysis of the intervention.
Evaluate if the (private and public) cost for intervention (using MI Health education during the intervention from pregnancy until the child reaches the age of 3 years) are higher than the gain - measured as total (private and public) cost for each avoided dental treatment (e.g. filling or extraction) due to dental caries. The assessments will be based on Clinical assumptions of time and estimations of private cost.
Measured: Evaluated when the child is 6 years old.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Jan 2013
- Primary completion31 May 2022
- Study completion17 Jun 2022
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 Dental Caries in ChildrenStudies of the same condition, open and under way.
- 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
- Model description
- This is a prospective randomized case control study following a cohort, of Children - whose mothers received extended oral health education from (before) birth until their 3-year dental examination - until their 6-year examniation, and comparing the results (e.g. caries experience and economical aspects) with a control group of age-matched individuals born during the same period. The study group of pregnant mothers (and their children) at the local Public Dental Clinic will be compared to a group of other pregnant mothers (and their children) and pregnant mothers (and their children) from the other dental clinics in the city and from another Public Dental Clinic with similar socioeconomic problems and similar caries prevalence as the clinic of the intervention group.
- Masking
- None (open label)
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mats Bågesund
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Sponsor-investigator, Mats Bågesund, Region Östergötland
- Investigators
- Mats Bågesund, Assoc Prof, Principal investigator, Linköping University / Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389905
- Sponsor's protocol ID
- EquHag 2012
- Other IDs
- Dnr 2012/259-31, Dnr 2018/367-32
- Acronym
- EOH
- Status last verified
- Jun 2022
- First submitted
- 24 Apr 2020
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blomma C, Aronsson K, Bagesund M, Risberg MB, Gerdin EW, Davidson T. Evaluation of an early childhood caries preventive programme starting during pregnancy-Results after 3 and 6 years. Int J Paediatr Dent. 2024 Nov;34(6):744-754. doi: 10.1111/ipd.13174. Epub 2024 Mar 10.
PubMed 38462758
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equal Oral Health in Children: The Hageby-model
- ClinicalTrials.gov ID
- NCT04389905
- Acronym / sponsor ID
- EOH / EquHag 2012
- Conditions
- Dental Caries in Children, Economic Problems, Infant Conditions, Child, Preschool, Pregnancy Related, Educational Problems
- Keywords
- Dental Caries in Children, Pregnancy, Infant Conditions, Economic Problems, Child, Preschool, Health Education, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- Mats BågesundUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 15 May 2020 (actual)
- 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.
Pregnant women - living in thecatchment area of a public dental clinic with known higher caries experience and generally lower socioeconomical status than at other dental clinics in the Region - are recruited for the study.
Repeated information and surveys of dental knowledge, dental habits and medical conditions etc. is sample.
Before birth, one month after birth, and 12 and 18 months after birth of the Child, the mother repeatedly answers questionnaires and recieves information about dental care.
At 18 months,and at the 3- and 6-year dental examinations the caries experience dmft/deft is registered.
All Children and accompanying parent receives an individual caries preventive program between the examinations.
Evaluation will be focused on possible caries sreduction and Health econimic aspects of the interventions.
Detailed description
- At the first visit to maternal health care: Preliminary caries risk assessment of the family using questionnaire 1 to the expectant mother and father / partner. The invitation and time are given for an initial health call. The invitation is translated into the most common languages in Hageby and Navestad. If a translation into the current language is missing, an interpreter is hired.
- During pregnancy: Health talk with specially trained dental hygienist / dental nurse at the local Public Dental Clinic (Folktandvården Hageby). Determination of the family's risk assessment in accordance with the criteria of the regional Public Dental Service in the County of Östergötland is adapted for the project.
- One-month monitoring in child health care: Follow-up of caries risk assessment of the family with the help of questionnaire 2 to future mother and father / partner.
- Care program 6-18 months with different designed depending on caries risk.
- At 12 months: Group information or individual call, depending on risk, in collaboration with child health care. Follow-up of the family's caries risk assessment with questionnaire 3 to the expectant mother and father / partner.
- At 18 months regardless of risk: Health talk, examination and renewed caries risk assessment of the child according to the criteria of the Public Dental Service.
- Dental care program 18-30 months, individually designed depending on caries risk evaluation: Oral health behavior is evaluated using a caries risk assessment questionnaire. The questions in the form are based on factors that are of importance for caries development, and are supplemented with information from the maternity care and social services medical records. The questionnaire is constructed with yes and no as a response alternative, where the no-answers, together with an assessment of a dietary registration, indicate an increased risk of developing caries. The questionnaire registers risk behavior as a point. The evaluation is conducted as an assessment of changed risk points. The baseline data uses the score from the first questionnaire to be answered during pregnancy, according to point 1 above in the dental care program. The questionnaire is constructed based on known risk factors for caries, but has not been validated for measuring oral health behavior. A validation is therefore planned to be implemented as part of the project and applied for separately. Caries prevalence is evaluated by routinely collected caries epidemiological data when the children are 3 and 6 years and reported as the proportion of caries-free children, average dmft (= caries, extracted and filled teeth) and proportion of children with deft> =5. Three and six years are so-called indicator ages for caries epidemiological records. This means that caries data at the personal number level for all children in Östergötland are reported to the County Council. Participation in the dental care program is reported as the proportion of pregnant women who participate in the first health call compared to the proportion of pregnant women in control group 1 who participate in maternal health care's regular parental education on oral health at the midwifery. The usefulness of the questionnaire as a screening instrument is evaluated by comparing the outcome of the risk assessment with the caries outcome when the children in the control group are 3 and 6 years, respectively. The health economic evaluation focuses on cost efficiency. All costs associated with the intervention are recorded and calculated. Effects are calculated in the form of the number of people who come to the health interviews and meetings, changes in behavior, and in the longer term the changes in the number of dmft that occur. Cost efficiency is therefore calculated as the extra cost incurred per extra power (e.g. cost per person coming or cost per prevented dmft). The evaluation mainly uses a socio-economic perspective, which means that all costs and effects that arise at different levels in society are taken into account.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective randomized case control study following a cohort, of Children - whose mothers received extended oral health education from (before) birth until their 3-year dental examination - until their 6-year examniation, and comparing the results (e.g. caries experience and economical aspects) with a control group of age-matched individuals born during the same period. The study group of pregnant mothers (and their children) at the local Public Dental Clinic will be compared to a group of other pregnant mothers (and their children) and pregnant mothers (and their children) from the other dental clinics in the city and from another Public Dental Clinic with similar socioeconomic problems and similar caries prevalence as the clinic of the intervention group.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing Oral Health Education Group | Experimental | Behavioral: Dental education - Motivational InterviewingThe intervention group focused on the mothers from before birth until their child reached the age of 3 years. They received repeated questionnaires and repeated oral health education using the Motivational Interviewing (MI) technique. |
| Local Control Group | No intervention | –The local control group included other mothers and their children, who were (randomized according to) born during the same time as the children in the intervention group. They received only a questionnaire before their children were born. Caries data from 3- and 6-year examination is used. |
| Similar Socio-economics Control Group | No intervention | –This control group is from a Public Dental Clinic with similar socioeconomics (among the families in the catchment area of the clinic) as in the intervention group. This control group included mothers and their children, who were (randomized according to) born during the same time as the children in the intervention group. They received only a questionnaire before their children were born. Caries data from 3- and 6-year examination is used. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pregnant woman visiting maternal health care at the Vrinevi Hospital, Norrköping, for the current pregnancy during the time of the study.
- The expecting mother's accommodation - during the time of the study - is at an address within Hageby and Navestad (defined as associated socio-economic cluster status 5). (Socio-economic affiliation).
- The participating Child must be examined in the Public Dental Service at the 3- and 6-year examinations.
Key exclusion criteria (2 listed)
- Other home address than mentionned above.
- Moved out of the area during the time of the study.
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 |
|---|---|---|
| Dental education - Motivational InterviewingAlso: QuestionnaireMotivational Interviewing - Focusing on oral/dental health | Behavioural | Motivational Interviewing Oral Health Education Group |
Primary outcome
Early Childhood Caries (ECC) experience/prevalence at 3-years age
Time frame: The outcome of ECC experience/prevalence is evaluated at 3-years age
Early Childhood Caries experience/prevalence (dmft/deft)
Early Childhood Caries (ECC) experience/prevalence at 6-years age
Time frame: The outcome of ECC experience/prevalence is evaluated at 6-years age
Early Childhood Caries experience/prevalence (dmft/deft)
1 secondary outcome
Cost-benefit analysis of the intervention.
Time frame: Evaluated when the child is 6 years old.
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 21 Jun 2022.
- Derived from this study: PubMed 38462758Blomma C, Aronsson K, Bagesund M, Risberg MB, Gerdin EW, Davidson T. Evaluation of an early childhood caries preventive programme starting during pregnancy-Results after 3 and 6 years. Int J Paediatr Dent. 2024 Nov;34(6):744-754. doi: 10.1111/ipd.13174. Epub 2024 Mar 10.
- Individual participant dataSharing planned: No
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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.
Mats Bågesund, Assoc Prof principal investigator
Linköping University / Region Östergötland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental education - Motivational Interviewing in people with Dental Caries in Children and Economic Problems, run by Mats Bågesund 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 21 Jun 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?
Early Childhood Caries (ECC) experience/prevalence at 3-years age (time frame: The outcome of ECC experience/prevalence is evaluated at 3-years age). The study lists 2 primary outcomes in all. 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 NCT04389905, 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 21 Jun 2022.