Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04389905 |
| Other study ID # |
EquHag 2012 |
| Secondary ID |
Dnr 2012/259-31D |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2013 |
| Est. completion date |
June 17, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Region Östergötland |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
