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KnowledgeNCT05570500

Comparing the Effect of Online and Conventional Oral Health Education in Egypt

A study testing Oral health education in people with Knowledge and Attitude to Health, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to compare the results of online oral health education and conventional oral health education methods in terms of their effectiveness towards improving the knowledge and practice of oral hygiene in primary school children in Egypt. Read more about this study

Who is it for?
Ages 7 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Knowledge, Attitude to Health, Practice
What is being tested?
Oral health education
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
636 participants
Where
1 siteEgypt
Study dates
12 Dec 2022to 25 Mar 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 7 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 3rd and 4th grade Egyptian students.
  • Average of age 7-10 years old.
  • Currently residing in Egypt.
  • Both male and female students.

Who cannot join

  • Those who do not consent to participate in the study.
  • Those who cannot speak English or Arabic.
  • Non-Egyptians

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Futures language schools

    Cairo, Sherook Province

Other trials in Egypt

About this study

Official title: Comparing the Effect of the Online Oral Health Education to the Conventional Method on the Knowledge and Practice of Personal Oral Hygiene in a Group of Primary School Children in Egypt. A Randomized Controlled Trial

This study aims to compare the results of online oral health education and conventional oral health education methods in terms of their effectiveness towards improving the knowledge and practice of oral hygiene in primary school children in Egypt.

This study is done in two schools in Egypt, in 3rd and 4th grade respectfully. The classrooms in each grade will be randomly assigned to each of the two groups (online and conventional oral health education). A questionnaire that assesses knowledge and attitude towards self oral care will be administered by the primary investigator before and after the oral health education sessions. The pre and post questionnaires will be compared in terms of results to evaluate the effectiveness of both methods.

Being tested
Oral health education
Keywords
oral health education, oral health promotion, school children

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral health educationBehavioural

    oral health education sessions that aims to improve both knowledge of primary school children regarding bacteria, caries, number of teeth, plaque formation and attitude of primary school children regarding tooth brushing techniques, number of times per day, dietary instructions to avoid dental caries.

Study groups in NCT05570500
Study groupRoleWhat they receive
Control group, conventional oral health education groupPlacebo comparatorNot described
Receives: Behavioral: Oral health education
Comparison group, online oral health education groupActive comparatorNot described
Receives: Behavioral: Oral health education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of Oral Health Education on the Oral Health Knowledge in Primary School Children Aged 7-9 Years Old

    A questionnaire will be assigned to the participants to determine level of knowledge. Higher mean value of correct answer is considered to be of satisfactory outcome. lesser mean value of correct answers is considered to be unsatisfactory.

    The scale of measurement would be the total number of scores per participant entry on the knowledge section of the questionnaire. The knowledge section of the questionnaire contains 5 questions, 4 single answer questions and 1 multiple-answer question with two correct answers. The total score for the knowledge section is 6 marks (4+2), where the lowest score is 0 and the highest is 6. Higher scores mean better outcomes and lower scores mean worse outcomes.

    Measured: 2 months

Secondary outcomes (1)

  1. Effect of Oral Health Education on Oral Hygiene Measures Practice in Primary School Children Aged 7-9 Years Old

    A questionnaire will be assigned to the participants to determine the practice level of children towards oral hygiene. The scale of measurement would be on a percentage of correct answers, with minimum value denoting 0% and maximum value of 100%. Higher scores mean better outcomes and lower scores mean worse outcomes.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2022
  2. Study start12 Dec 2022
  3. Primary completion20 Mar 2023
  4. Study completion25 Mar 2023

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
636 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05570500
Sponsor's protocol ID
DPH20-3M
Status last verified
Jan 2024
First submitted
22 Sep 2022
Last updated
10 Jan 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • WHO, EMRO (2014, September 3). WHO EMRO | Egypt releases results of epidemiological study on oral health status. Available from: http://www.emro.who.int/egy/egypt-events/results-of-epidemiological-study-on-oral-health-status-released.html

  • Mohamed, yomna. (2020). Assessment of the Knowledge and Awareness Among Egyptian Parents in Relation To Oral Health Status of Their Children. Egyptian Dental Journal, 66(2), 737-746. https://doi.org/10.21608/edj.2020.25196.1058

  • Gambhir RS, Sohi RK, Nanda T, Sawhney GS, Setia S. Impact of school based oral health education programmes in India: a systematic review. J Clin Diagn Res. 2013 Dec;7(12):3107-10. doi: 10.7860/JCDR/2013/6212.3718. Epub 2013 Dec 15.

    PubMed 24551745

  • Alsumait A, ElSalhy M, Amin M. Long-Term Effects of School-Based Oral Health Program on Oral Health Knowledge and Practices and Oral Health-Related Quality of Life. Med Princ Pract. 2015;24(4):362-8. doi: 10.1159/000430096. Epub 2015 Jun 2.

    PubMed 26045154

  • 5- WHO (2020) Timeline: WHO's COVID-19 response. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/interactive-timeline?gclid=Cj0KCQjwufn8BRCwARIsAKzP6964UmFJZqWX9mc0tE7Fu5DVDnlzOskefX9AJAtBy8zOdgnZqtCPK3gaAoUhEALw_wcB

  • 6- WHO (2020) health topics / coronavirus. Available from: https://www.who.int/health-topics/coronavirus#tab=tab_1

  • 7- Ayoub, G. M. (2019). Teachers' experiences in overcrowded classrooms in Egyptian public schools.

  • 8- Egyptian ministry of education online portal. Available from: http://portal.moe.gov.eg/eng/Pages/default.aspx#

  • Kwan SY, Petersen PE, Pine CM, Borutta A. Health-promoting schools: an opportunity for oral health promotion. Bull World Health Organ. 2005 Sep;83(9):677-85. Epub 2005 Sep 30.

    PubMed 16211159

  • 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

  • GeethaPriya PR, Asokan S, Kandaswamy D, Shyam S. Impact of different modes of school dental health education on oral health-related knowledge, attitude and practice behaviour: an interventional study. Eur Arch Paediatr Dent. 2020 Jun;21(3):347-354. doi: 10.1007/s40368-019-00489-7. Epub 2019 Nov 16.

    PubMed 31734931

  • Cascaes AM, Bielemann RM, Clark VL, Barros AJ. Effectiveness of motivational interviewing at improving oral health: a systematic review. Rev Saude Publica. 2014 Feb;48(1):142-53. doi: 10.1590/s0034-8910.2014048004616.

    PubMed 24789647

  • 13- Miller, W. R., & Rollnick, S. (2002). Motivational interviewing: Preparing people for change (2nd ed.). The Guilford Press.

  • Gao X, Lo EC, McGrath C, Ho SM. Face-to-face individual counseling and online group motivational interviewing in improving oral health: study protocol for a randomized controlled trial. Trials. 2015 Sep 18;16:416. doi: 10.1186/s13063-015-0946-0.

    PubMed 26385340

  • 15- Acharya, Sonu. (2019). Motivational Interviewing in Pediatric Dentistry: Role in Behavior Management. Journal of South Asian Association of Pediatric Dentistry. 2. 69-72. 10.5005/jp-journals-10077-3030.

Questions about this trial

What is this clinical trial studying?

A study testing Oral health education in people with Knowledge and Attitude to Health, run by Ain Shams University at 1 site in Egypt.

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 4 inclusion and 3 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 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 10 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Effect of Oral Health Education on the Oral Health Knowledge in Primary School Children Aged 7-9 Years Old (time frame: 2 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 NCT05570500, which also lists 15 linked publications.

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 10 Jan 2024.

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