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

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05570500
Collaborator
(none)
636
Enrollment
1
Location
2
Arms
2.6
Anticipated Duration (Months)
245
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Oral health education
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
636 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Other
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
Actual Study Start Date :
Dec 12, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control group, conventional oral health education group

Behavioral: Oral 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.
Active Comparator: Comparison group, online oral health education group

Behavioral: Oral 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.

Outcome Measures

Primary Outcome Measures

  1. Effect of oral health education on the oral health knowledge in primary school children aged 7-9 years old [2 months]

    A questionnaire will be assigned to the participants to determine level of knowledge. 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.

Secondary Outcome Measures

  1. Effect of oral health education on oral hygiene measures practice in primary school children aged 7-9 years old [2 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 2nd and 3rd grade Egyptian students.

  • Average of age 7-9 years old.

  • Currently residing in Egypt.

  • Both male and female students.

Exclusion Criteria:

  • Those who do not consent to participate in the study.

  • Those who cannot speak English or Arabic.

  • Non-Egyptians

Contacts and Locations

Locations

Site City State Country Postal Code
1 Futures language schools Cairo Sherook Province Egypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

  • Study Director: Amira S Badran, PHD, Ain Shams University
  • Principal Investigator: Omar A Taqa, student, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Omar Alaa Taqa, Master's degree student, Ain Shams University
ClinicalTrials.gov Identifier:
NCT05570500
Other Study ID Numbers:
  • DPH20-3M
First Posted:
Oct 6, 2022
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Omar Alaa Taqa, Master's degree student, Ain Shams University
oral health education
oral health promotion
school children

Study Results

No Results Posted as of Jan 31, 2023