Equal Oral Health in Children: The Hageby-model (EOH)

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries in Children; Pregnancy Related; Infant Conditions; Risk Reduction; Educational Problems; Economic Problems; Child, Preschool
• Intervention / Treatment: Behavioral: Dental education - Motivational Interviewing

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.

• Study Type: Interventional
• Enrollment (Actual): 667
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Östergötland
    • Norrköping, Östergötland, Sweden, SE-60182
      • Mats Bågesund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational Interviewing Oral Health Education Group; 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.	Behavioral: Dental education - Motivational Interviewing; Motivational Interviewing - Focusing on oral/dental health; Other Names: Questionnaire
No Intervention: Local Control Group; 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.
No Intervention: Similar Socio-economics Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Childhood Caries (ECC) experience/prevalence at 3-years age	Early Childhood Caries experience/prevalence (dmft/deft)	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)	The outcome of ECC experience/prevalence is evaluated at 6-years age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Evaluated when the child is 6 years old.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oral Health related knowledge level among mothers (after MI Health Education).	Changed percentage of correct answers to questions in Questionnaire [Repeated use of a regionally designed questionnaire will be used to evaluate if the mothers' level of oral health related knowledge will change following the intervention.]	Baseline questionnaire answered before birth compared to [possible change in percentage correct answers] after 12 months

Collaborators and Investigators

• Sponsor: Mats Bågesund
• Collaborators: Linkoeping University
• Investigators: Principal Investigator: Mats Bågesund, Assoc Prof, Linköping University / Region Östergötland

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): June 17, 2022

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Child, Preschool; Health Education, Dental; Dental Caries in Children; Infant Conditions; Economic Problems
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: EquHag 2012; Dnr 2012/259-31 (Other Identifier: Regional Ethical Board Linköping); Dnr 2018/367-32 (Other Identifier: Regional Ethical Board Linköping)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No