Clinical trial NCT04389905: Equal Oral Health in Children: The Hageby-model
Official title: Equal Oral Health in Children: The Hageby-model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Economic Problems
Infant Conditions
Child, Preschool
Pregnancy Related
Educational Problems
Risk Reduction
Keywords: Dental Caries in Children
Pregnancy
Infant Conditions
Economic Problems
Child, Preschool
Health Education, Dental
Lead sponsor: Region Östergötland
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2020-05-15
Enrollment: 667
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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: 1. 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.
2. 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.
3. 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.
4. Care program 6-18 months with different designed depending on caries risk.
5. 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.
6. 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.
7. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Other home address than mentionned above.
* Moved out of the area during the time of the study.

Primary outcomes:
measure: Early Childhood Caries (ECC) experience/prevalence at 3-years age
timeFrame: The outcome of ECC experience/prevalence is evaluated at 3-years age
measure: Early Childhood Caries (ECC) experience/prevalence at 6-years age
timeFrame: The outcome of ECC experience/prevalence is evaluated at 6-years age
Secondary outcomes:
measure: Cost-benefit analysis of the intervention.
timeFrame: Evaluated when the child is 6 years old.
Other outcomes:
measure: Change in Oral Health related knowledge level among mothers (after MI Health Education).
timeFrame: Baseline questionnaire answered before birth compared to [possible change in percentage correct answers] after 12 months
Locations:
city: Norrköping
country: Sweden
facility: Mats Bågesund
state: Östergötland
Study officials:
affiliation: Linköping University / Region Östergötland
name: Mats Bågesund, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: