Equal Oral Health in Children: The Hageby-model

NCT04389905 | Completed DMC

• 3 other identifiers: EquHag 2012Dnr 2012/259-31Dnr 2018/367-32
• Study Type: interventional
• Target: 667
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Cost-benefit analysis of the intervention.

  Evaluated when the child is 6 years old.

Other Outcomes (1)

• Change in Oral Health related knowledge level among mothers (after MI Health Education).

  Baseline questionnaire answered before birth compared to [possible change in percentage correct answers] after 12 months

Study Arms (3)

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.

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.

Interventions

Dental education - Motivational Interviewing BEHAVIORAL

Motivational Interviewing - Focusing on oral/dental health

Also known as: Questionnaire

Motivational Interviewing Oral Health Education Group

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mats Bågesund: lead
• Linkoeping University: collaborator

Study Sites (1)

Mats Bågesund

Norrköping, Östergötland County, SE-60182, Sweden

Location

MeSH Terms

Conditions

Risk Reduction Behavior; Health Education

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mats Bågesund, Assoc Prof

  Linköping University / Region Östergötland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, PhD, Assistant Professor, Research Counselor, Senior Consultant Specialist in Pediatric Dentistry

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 15, 2020
• Study Start: January 1, 2013
• Primary Completion: May 31, 2022
• Study Completion: June 17, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)