NCT01854502

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
804

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

3.7 years

First QC Date

May 3, 2013

Last Update Submit

May 3, 2017

Conditions

Keywords

Young childrencounselingfluoridexylitol

Outcome Measures

Primary Outcomes (1)

  • 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.

    At the age of 2 years

Secondary Outcomes (1)

  • Dental caries

    at the age of two

Other Outcomes (1)

  • Tooth brushing

    At the age of two

Study Arms (3)

Oral hygiene and fluoride use

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Diet and use of xylitol

EXPERIMENTAL

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

Interventions

Parents were given instructions how to brush and clean between teeth and to use fluoride toothpaste two times a day.

Oral hygiene and fluoride use

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.

Diet and use of xylitol

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • first born children born in 2008

You may not qualify if:

  • not first born children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health and social and welfare affairs, oral health

Vantaa, 01510, Finland

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • Arpalahti I, Hanninen K, Tolvanen M, Varrela J, Rice DP. The effect of early childhood non-nutritive sucking behavior including pacifiers on malocclusion: a randomized controlled trial. Eur J Orthod. 2024 Oct 1;46(5):cjae024. doi: 10.1093/ejo/cjae024.

Related Links

MeSH Terms

Conditions

Dental PlaqueDental CariesHabits

Interventions

Oral HygieneDiet

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesTooth DemineralizationBehavior

Intervention Hierarchy (Ancestors)

HygieneTherapeuticsPreventive DentistryDentistryNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Kaisu Pienihäkkinen, docent

    University of Turku

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief dentist

Study Record Dates

First Submitted

May 3, 2013

First Posted

May 15, 2013

Study Start

January 1, 2008

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

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

Locations