CClinicalTrials.gg
CompletedNCT05570500Updated Jan 10, 2024Results posted

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

An interventional study of Oral health education in Knowledge, Attitude to Health and Practice, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 7 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-10.

Sponsored by Ain Shams University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
636
Allocation
Randomized
Ages
7 Years to 10 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Knowledge
  • Attitude to Health
  • Practice

Keywords

  • oral health education
  • oral health promotion
  • school children
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,879 studies on the registry; 424 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Those who do not consent to participate in the study.
  • Those who cannot speak English or Arabic.
  • Non-Egyptians
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
636 participants (actual)

Study arms

  • Placebo comparator
    Control group, conventional oral health education group

    Behavioral: Oral health education

  • Active comparator
    Comparison group, online oral health education group

    Behavioral: Oral health education

Interventions

  • BehavioralOral health education

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 2 months

Secondary outcomes

  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.

    Time frame: 2 months

07

Results

Posted Jan 10, 2024

Participant flow

Participant flow — Overall Study
MilestoneComparison Group, Online Oral Health Education GroupControl Group, Conventional Oral Health Education Group
Started319317
Classroom 1 in each study group4240
Classroom 2 in each study group3839
Classroom 3 in each study group3941
Classroom 4 in each study group3642
Classroom 5 in each study group4137
Classroom 6 in each study group4039
Classroom 7 in each study group4341
Classroom 8 in each study group4038
Completed312312
Not completed75
Withdrew: Lost to follow-up75

Outcome measures

PrimaryEffect 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.

Time frame:
2 months
Reported as:
Mean · knowledge score on a scale
Effect of Oral Health Education on the Oral Health Knowledge in Primary School Children Aged 7-9 Years Old
knowledge score on a scaleControl Group, Conventional Oral Health Education GroupComparison Group, Online Oral Health Education Group
Effect of Oral Health Education on the Oral Health Knowledge in Primary School Children Aged 7-9 Years Old2.71 ± 1.530.81 ± 1.16
SecondaryEffect 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.

Time frame:
2 months
Reported as:
Count of participants · Participants
Effect of Oral Health Education on Oral Hygiene Measures Practice in Primary School Children Aged 7-9 Years Old
ParticipantsControl Group, Conventional Oral Health Education GroupComparison Group, Online Oral Health Education Group
participants who brushed their teeth two times or more224208
participants who brushed less than two times or forgot to brush their teeth8497
participants who dont brush their teeth47

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control Group, Conventional Oral Health Education Group———
Comparison Group, Online Oral Health Education Group———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Control Group, Conventional Oral Health Education GroupComparison Group, Online Oral Health Education GroupTotal
<=18 years312312624
Between 18 and 65 years000
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Control Group, Conventional Oral Health Education GroupComparison Group, Online Oral Health Education GroupTotal
Female165150315
Male147162309
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Control Group, Conventional Oral Health Education GroupComparison Group, Online Oral Health Education GroupTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Control Group, Conventional Oral Health Education GroupComparison Group, Online Oral Health Education GroupTotal
Egypt312312624
08

Study locations

1 site
  • Futures language schools
    Cairo, Sherook Province, Egypt
09

References and documents

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.

Study documents

  • Study protocol · Nov 21, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05570500
Lead sponsor
Ain Shams University
Responsible party
Omar Alaa Taqa (Master's degree student, Ain Shams University) — Principal investigator
First posted
Oct 6, 2022
Start date
Dec 12, 2022
Primary completion
Mar 20, 2023
Completion
Mar 25, 2023
Results posted
Jan 10, 2024
Last update
Jan 10, 2024

Study contacts

Amira S Badran, PHD
study director · Ain Shams University
Omar A Taqa, student
principal investigator · Ain Shams University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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