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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01854502
Other study ID # IArpalahti2008
Secondary ID
Status Completed
Phase N/A
First received May 3, 2013
Last updated May 3, 2017
Start date January 2008
Est. completion date December 2011

Study information

Verified date May 2017
Source University of Turku
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 804
Est. completion date December 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- first born children born in 2008

Exclusion Criteria:

- not first born children

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Finland Health and social and welfare affairs, oral health Vantaa

Sponsors (1)

Lead Sponsor Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

References & Publications (3)

Arpalahti I, Järvinen M, Kommonen HM, Tolvanen M, Pienihäkkinen 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. — View Citation

Arpalahti I, Järvinen M, Suni J, Pienihäkkinen 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 — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Tooth brushing the habit of tooth brushing at the age of two years was asked by a questionnaire At the age of two
Primary 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 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. at the age of two
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