Plain English Summary
Background and study aims
This study investigates whether individually tailored education for adolescents on how to take care of their teeth improves their oral self-care.
Who can participate?
All 15-16 year old pupils attending one of the four public secondary schools participating in the study.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the intervention group receive oral self-care education provided by their school. Those in the control group carry on as usual. Three oral cleanliness assessments are then done for the control group (at the start of the study, and then 6 months and 12 months later) and four oral cleanliness assessments are completed by the intervention group (before the study begins, after the intervention, 6 months and then 12 months later)
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Four Lithuania secondary schools
When is the study starting and how long is it expected to run for?
December 2013 to September 2015
Who is funding the study?
Vilnius University (Lithuania)
Who is the main contact?
Dr Vilma Brukiene
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6B-12-352
Study information
Scientific title
Self-efficacy theory based oral hygiene intervention in adolescents: cluster randomized controlled trial. Focus on oral self care practice and skills
Acronym
Study hypothesis
Multiple individualized instructions are superior to conventional dental instruction for improving both oral self-care skills and practice in adolescents
Ethics approval
Bioethics Committee of the Ministry of Health, Lithuania
Study design
Cluster randomized controlled trial
Primary study design
Interventional
Secondary study design
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Oral self care
Intervention
All 15- to 16-years-old from four public secondary schools were invited to participate. 112 were randomly allocated in the intervention group and 94 to the control group. All interventions were implemented through a school-based environment and aimed to improve the oral hygiene skills and practice of the 15-16 years old children. Three oral cleanliness assessments were done for the control group (baseline, 6 and 12 months) and four oral cleanliness assessments were completed for the intervention group (baseline, after intervention, 6 and 12 months).
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Oral self care skills
Three assessments for control group (baseline, 6 and 12 months)
Four assessments for intervention group (baseline, after intervention, 6 and 12 months)
Secondary outcome measures
Oral self care practice
Three assessments for control group (baseline, 6 and 12 months)
Four assessments for intervention group (baseline, after intervention, 6 and 12 months)
Overall trial start date
05/12/2013
Overall trial end date
14/09/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy school-aged 15 -16 years old attending public schools
Participant type
All
Age group
Child
Gender
Both
Target number of participants
254
Participant exclusion criteria
Adolescents undergoing orthodontic treatment
Recruitment start date
10/01/2014
Recruitment end date
07/02/2014
Locations
Countries of recruitment
Lithuania
Trial participating centre
Lithuania secondary schools
Vilnius District
21375
Lithuania
Funders
Funder type
University/education
Funder name
Vilnius University (Lithuania)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
02/11/2015
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list