Family-based Counseling Models for Young Children

May 3, 2017 updated by: Irma Arpalahti, University of Turku

Organizing Family-based Health Promotion for Young Children in Public Dental Service

The purpose of this study is to compare the effects of two new family-based oral health promotion programs with the routine program in use earlier in Vantaa public dental service. The children born in 2008 were followed from their first visit to public dental service at the age of 6-12 months to their dental examination at the age of 2-2½ years. The outcome measures are the colonization of mutans streptococci in dental plaque, dental caries, and the oral health habits of two-year-olds.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators hypothesized that the training of the dental professionals involved in children's examinations could improve the quality of the counseling, raise the level of commitment, and give them a new kind of perspective on early childhood oral health counseling. Health promotion programs with clinical guidance aimed also at the parents themselves might commit the families to maintain their children's good oral health.

All programs (two new and the control program) consisted of the basic elements of oral health counseling for the children. The counseling included regular oral hygiene, i.e. tooth brushing with fluoride-containing toothpaste twice a day, advice of a healthy diet with proper timing and composition of meals avoiding sugary snacks, and to use xylitol products on regular basis. Additionally, in the program of oral hygiene and fluoride, the parents were given counseling on how to brush their own teeth with fluoride-containing toothpaste and clean between them. In the program of diet and xylitol parent was asked to fill in one-day diary of his or her own diet in the waiting room, and the dental professional pointed out the frequency of meals and snacks, as well as suggested the use of xylitol 5 grams per day.

The children, accompanied by their parents, were clinically examined in various health clinics of the Vantaa public dental service. At the regular two-year visit, the dental hygienists and in-service trained dental nurses tested the children for mutans streptococci in plaque. The transtheoretical model and the motivational interviewing were introduced to the dental hygienists and in-service trained dental nurses to use in preventive counseling.

The results of this study will be published in three articles.

Study Type

Interventional

Enrollment (Actual)

804

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Vantaa, Finland, 01510
        • Health and social and welfare affairs, oral health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • first born children born in 2008

Exclusion Criteria:

  • not first born children

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oral hygiene and fluoride use
Parents of young children were given counseling of their own oral hygiene and the use of fluoride on their child's visit to public dental service. The child was given multi-faceted counseling for good oral health habits.
Behavioral: Oral hygiene and fluoride use
Parents were given instructions how to brush and clean between teeth and to use fluoride toothpaste two times a day.
NO_INTERVENTION: Control

Control, The parents were not given any intervention on their child's visit to public dental service.

The child was given multi-faceted counseling for good oral health habits.
EXPERIMENTAL: Diet and use of xylitol
Parents of young children were given counseling of their own diet and the use of xylitol on their child's visit to public dental service. The child was given multi-faceted counseling for good oral health habits.
Behavioral: Diet and use of xylitol
Parents were asked to fill in one-day diaries of their own diet in the waiting room. The dental professional pointed out the frequency of meals and snacks, as well as suggested the timing of xylitol products.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The colonization of mutans streptococci bacteria
Time Frame: At the age of 2 years
The children were tested for the amount of mutans streptococci bacteria in their dental plaque at the age of 2 years. The recommended age for testing was 2-2.5 years, and the inclusion limits 2 years and 3 years.
At the age of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental caries
Time Frame: at the age of two
At the age of two years, the children, accompanied by their parents, were clinically examined in the Vantaa PDS. The dental hygienists and in-service trained dental nurses that were working in each clinic performed the examinations by a mirror using the WHO criteria of the electronic patient database. The dental professionals were not blinded to the group of the child. The information from the clinical examinations, including the number of decayed teeth or teeth with distinct visual changes in enamel, was recorded on the database. No missed or filled teeth were found.
at the age of two

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth brushing
Time Frame: At the age of two
the habit of tooth brushing at the age of two years was asked by a questionnaire
At the age of two

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Investigators

  • Study Director: Kaisu Pienihäkkinen, docent, University of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 11, 2013

First Posted (ESTIMATE)

May 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IArpalahti2008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data is not planned to be shared with other researchers, it will be destroyed after the study.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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