NCT05570500

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
636

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 22, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 12, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2023

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

September 22, 2022

Results QC Date

October 1, 2023

Last Update Submit

January 9, 2024

Conditions

Keywords

oral health educationoral health promotionschool children

Outcome Measures

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.

    2 months

Secondary Outcomes (1)

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

    2 months

Study Arms (2)

Control group, conventional oral health education group

PLACEBO COMPARATOR
Behavioral: Oral health education

Comparison group, online oral health education group

ACTIVE COMPARATOR
Behavioral: Oral health education

Interventions

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.

Comparison group, online oral health education groupControl group, conventional oral health education group

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Futures language schools

Cairo, Sherook Province, Egypt

Location

Related Publications (15)

  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 24551745BACKGROUND
  • 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.

    PMID: 26045154BACKGROUND
  • 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

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

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

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

    BACKGROUND
  • 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.

    PMID: 16211159BACKGROUND
  • 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.

    PMID: 25924670BACKGROUND
  • 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.

    PMID: 31734931BACKGROUND
  • 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.

    PMID: 24789647BACKGROUND
  • 13- Miller, W. R., & Rollnick, S. (2002). Motivational interviewing: Preparing people for change (2nd ed.). The Guilford Press.

    BACKGROUND
  • 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.

    PMID: 26385340BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Interventions

Health Education, Dental

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health DentistryEnvironment and Public Health

Results Point of Contact

Title
Dr. Omar Alaa Taqa
Organization
Ain Shams University

Study Officials

  • Amira S Badran, PHD

    Ain Shams University

    STUDY DIRECTOR
  • Omar A Taqa, student

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the participants will know the group they are assigned to since they need to access the online oral health education sessions in case of being assigned to that group. The participants in conventional method will receive their oral health education sessions in their classrooms directly, thus making it impossible to mask both participant groups. the care provider is the primary investigator, and he is the person responsible of delivering the oral health education sessions which makes it impossible to mask the intervention details. Only the outcomes assessor (which is the statistician) will be blinded from the groups involved, names of participants and study details.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's degree student

Study Record Dates

First Submitted

September 22, 2022

First Posted

October 6, 2022

Study Start

December 12, 2022

Primary Completion

March 20, 2023

Study Completion

March 25, 2023

Last Updated

January 10, 2024

Results First Posted

January 10, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations