CariesNCT02320162
School-based Oral Health Education Program Using Experiential Learning
A study testing Experiential learning oral health education in people with Caries and Gingivitis, run by Matina Angelopoulou.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Gingivitis
- What is being tested?
- Experiential learning oral health education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 351 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Contributory medical history
About this study
Official title: "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.
- Conditions
- Caries, Gingivitis
- Being tested
- Experiential learning oral health education
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experiential learning oral health educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Experiential learning | Experimental | Oral health education using experiential learning (EL) Receives: Behavioral: Experiential learning oral health education |
| Traditional lecturing | Placebo comparator | Oral health education using traditional lecturing (TL) Receives: Behavioral: Experiential learning oral health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline, 6 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startFeb 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matina Angelopoulou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matina Angelopoulou, Marquette University
- Investigators
- Constantine Oulis, DDS,MS,PhD, Study chair, Dental School, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320162
- Sponsor's protocol ID
- Marquette U
- Status last verified
- Dec 2014
- First submitted
- 11 Dec 2014
- Last updated
- 30 Aug 2017
- Results posted
- No
Publications
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.
PubMed 25924670
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "School-based Oral Health Education Program Using Experiential Learning or Traditional Lecturing in Children and Adolescents: a Clinical Trial"
- ClinicalTrials.gov ID
- NCT02320162
- Acronym / sponsor ID
- Marquette U
- Conditions
- Caries, Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Matina AngelopoulouUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiential learning | Experimental | Behavioral: Experiential learning oral health educationOral health education using experiential learning (EL) |
| Traditional lecturing | Placebo comparator | Behavioral: Experiential learning oral health educationOral health education using traditional lecturing (TL) |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Contributory medical history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experiential learning oral health education | Behavioural | Experiential learning, Traditional lecturing |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Derived from this study: PubMed 25924670Angelopoulou 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.
Related trials for Caries
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Not yet recruiting
Clinical Performance of High Viscous Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment in Elderly Cancer Patients. (A 12-month Randomized Clinical Trial)
Dental Caries, Cervical Caries
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constantine Oulis, DDS,MS,PhD study chair
Dental School, University of Athens
Questions about this trial
What is this clinical trial studying?
A study testing Experiential learning oral health education in people with Caries and Gingivitis, run by Matina Angelopoulou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in dental plaque, gingivitis and caries at 6 and 18 months in 350 children (time frame: baseline, 6 and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02320162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017; AzTrials last refreshed its copy on 28 Oct 2026.