search
Back to results

Family-based Counseling Models for Young Children

Primary Purpose

Dental Plaque, Dental Caries, Behaviorial Habits

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Oral hygiene and fluoride use
Diet and use of xylitol
Sponsored by
University of Turku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring Young children, counseling, fluoride, xylitol

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • first born children born in 2008

Exclusion Criteria:

  • not first born children

Sites / Locations

  • Health and social and welfare affairs, oral health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Oral hygiene and fluoride use

Control

Diet and use of xylitol

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

The colonization of mutans streptococci bacteria
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.

Secondary Outcome Measures

Dental caries
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.

Full Information

First Posted
May 3, 2013
Last Updated
May 3, 2017
Sponsor
University of Turku
search

1. Study Identification

Unique Protocol Identification Number
NCT01854502
Brief Title
Family-based Counseling Models for Young Children
Official Title
Organizing Family-based Health Promotion for Young Children in Public Dental Service
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque, Dental Caries, Behaviorial Habits
Keywords
Young children, counseling, fluoride, xylitol

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
804 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral hygiene and fluoride use
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Diet and use of xylitol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Oral hygiene and fluoride use
Intervention Description
Parents were given instructions how to brush and clean between teeth and to use fluoride toothpaste two times a day.
Intervention Type
Behavioral
Intervention Name(s)
Diet and use of xylitol
Intervention Description
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.
Primary Outcome Measure Information:
Title
The colonization of mutans streptococci bacteria
Description
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.
Time Frame
At the age of 2 years
Secondary Outcome Measure Information:
Title
Dental caries
Description
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.
Time Frame
at the age of two
Other Pre-specified Outcome Measures:
Title
Tooth brushing
Description
the habit of tooth brushing at the age of two years was asked by a questionnaire
Time Frame
At the age of two

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: first born children born in 2008 Exclusion Criteria: not first born children
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaisu Pienihäkkinen, docent
Organizational Affiliation
University of Turku
Official's Role
Study Director
Facility Information:
Facility Name
Health and social and welfare affairs, oral health
City
Vantaa
ZIP/Postal Code
01510
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The individual participant data is not planned to be shared with other researchers, it will be destroyed after the study.
Citations:
PubMed Identifier
21699653
Citation
Arpalahti I, Jarvinen M, Suni J, Pienihakkinen K. Acceptance of oral health promotion programmes by dental hygienists and dental nurses in public dental service. Int J Dent Hyg. 2012 Feb;10(1):46-53. doi: 10.1111/j.1601-5037.2011.00517.x. Epub 2011 Jun 23.
Results Reference
result
PubMed Identifier
24348559
Citation
Arpalahti I, Tolvanen M, Pienihakkinen K. Comparing health promotion programs in public dental service of vantaa, Finland: a clinical trial in 6-36-month-old children. Int J Dent. 2013;2013:757938. doi: 10.1155/2013/757938. Epub 2013 Nov 18.
Results Reference
result
PubMed Identifier
27957564
Citation
Arpalahti I, Jarvinen M, Kommonen HM, Tolvanen M, Pienihakkinen K. Parental Opinions on Children's Oral Health Counselling and Readiness to Change Health Habits. Oral Health Prev Dent. 2016;14(6):535-545. doi: 10.3290/j.ohpd.a37139.
Results Reference
result
Links:
URL
http://urn.fi/URN:ISBN:978-951-29-6180-1
Description
Doctoral thesis (article-based)

Learn more about this trial

Family-based Counseling Models for Young Children

We'll reach out to this number within 24 hrs