NCT02320162

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
351

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
Last Updated

August 30, 2017

Status Verified

December 1, 2014

Enrollment Period

2.3 years

First QC Date

December 11, 2014

Last Update Submit

August 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in dental plaque, gingivitis and caries at 6 and 18 months in 350 children

    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

Study Arms (2)

Experiential learning

EXPERIMENTAL

Oral health education using experiential learning (EL)

Behavioral: Experiential learning oral health education

Traditional lecturing

PLACEBO COMPARATOR

Oral health education using traditional lecturing (TL)

Behavioral: Experiential learning oral health education

Interventions

Experiential learningTraditional lecturing

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Contributory medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Angelopoulou MV, Kavvadia K, Taoufik K, Oulis CJ. Comparative clinical study testing the effectiveness of school based oral health education using experiential learning or traditional lecturing in 10 year-old children. BMC Oral Health. 2015 Apr 28;15:51. doi: 10.1186/s12903-015-0036-4.

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Constantine Oulis, DDS,MS,PhD

    Dental School, University of Athens

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 19, 2014

Study Start

February 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 30, 2017

Record last verified: 2014-12