- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02320162
School-based Oral Health Education Program Using Experiential Learning
August 28, 2017 updated by: Matina Angelopoulou
"School-based Oral Health Education Program Using Experiential Learning or Traditional Lecturing in Children and Adolescents: a Clinical Trial"
The aim of this project was to compare the effectiveness of experiential learning (EL) and traditional lecturing (TL) school-based oral health education on the oral health knowledge, attitude, habits, oral hygiene, gingival health and caries incidence of 10 and 13-year-old Greek children.
Thee hundred and fifty children were selected from three areas of Greece.
Information on oral health knowledge, attitude and behaviour were obtained using a questionnaire.
Dental plaque was recorded using a modified hygiene index, gingivitis was assessed using the simplified gingival index and dental caries was measured by recording the number of Decayed, Missing and Filled teeth (DMFT) using the British Association for the Study of Community Dentistry (BASCD) criteria.
All children were examined by two calibrated dentists, using a World Health Organisation (WHO) periodontal probe and artificial light.
Questionnaires were delivered and clinical examinations were performed at baseline and at 6 and 18 months post-intervention.
The EL oral health educational program was implemented by teachers using the program's manual.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
351
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 10 and 13 year-old children
- For the EL group, students were recruited from schools that had teachers previously trained in EL
- Students recruited for the TL group attended schools of the same geographical location as students in the EL group
Exclusion Criteria:
- Contributory medical history
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experiential learning
Oral health education using experiential learning (EL)
|
|
Placebo Comparator: Traditional lecturing
Oral health education using traditional lecturing (TL)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in dental plaque, gingivitis and caries at 6 and 18 months in 350 children
Time Frame: baseline, 6 and 18 months
|
350 children were clinically examined and dental plaque, gingivitis and caries were recorded using appropriate indexes.
6 and 18 months later, children were re-examined using the same method to test if there was any change on the dental plaque, gingivitis and caries level and if this change differ significantly between the two different oral health education groups (Experiential learning or Traditional Lecturing).
|
baseline, 6 and 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Constantine Oulis, DDS,MS,PhD, Dental School, University of Athens
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
December 11, 2014
First Submitted That Met QC Criteria
December 15, 2014
First Posted (Estimate)
December 19, 2014
Study Record Updates
Last Update Posted (Actual)
August 30, 2017
Last Update Submitted That Met QC Criteria
August 28, 2017
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Marquette U
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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