Clinical trial NCT01854502: Family-based Counseling Models for Young Children
Official title: Organizing Family-based Health Promotion for Young Children in Public Dental Service
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Dental Caries
Behaviorial Habits
Keywords: Young children
counseling
fluoride
xylitol
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 804
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* first born children born in 2008

Exclusion Criteria:

* not first born children

Primary outcomes:
measure: The colonization of mutans streptococci bacteria
timeFrame: At the age of 2 years
Secondary outcomes:
measure: Dental caries
timeFrame: at the age of two
Other outcomes:
measure: Tooth brushing
timeFrame: At the age of two
Locations:
city: Vantaa
country: Finland
facility: Health and social and welfare affairs, oral health
Study officials:
affiliation: University of Turku
name: Kaisu Pienihäkkinen, docent
role: STUDY_DIRECTOR
References:
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.
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.
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.