Condition category
Oral Health
Date applied
30/07/2015
Date assigned
07/08/2015
Last edited
07/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Vilma Brukiene

ORCID ID

Contact details

Zalgirio 117
Vilnius
Lithuania
Vilnius
08217
Lithuania

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 measures

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

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

Sponsor information

Organisation

Institute of Odontology, Vilnius University

Sponsor details

Zalgirio 117
Vilnius
08217
Lithuania

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes