MedDataX Logo

Trial Outcomes & Findings for Comparing the Effect of Online and Conventional Oral Health Education in Egypt (NCT NCT05570500)

NCT ID: NCT05570500

Last Updated: 2024-01-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

636 participants

Primary outcome timeframe

2 months

Results posted on

2024-01-10

Participant Flow

Unit of analysis: Classrooms

Participant milestones

Participant milestones
Measure
Comparison Group, Online Oral Health Education Group
In this study group, participants received online oral health education session by logging in their Microsoft teams accounts. The intervention applied during the online oral health education session was in a form of pre-recorded cartoon presentation created by Prezi software.
Control Group, Conventional Oral Health Education Group
In this study group, participants received face-to-face oral health education session live inside their classrooms. The intervention applied during the conventional oral health education session was a live demo on toothbrushing techniques and a cartoon presentation created by using Prezi software.
Overall Study
STARTED
319 8
317 8
Overall Study
Classroom 1 in Each Study Group
42 1
40 1
Overall Study
Classroom 2 in Each Study Group
38 1
39 1
Overall Study
Classroom 3 in Each Study Group
39 1
41 1
Overall Study
Classroom 4 in Each Study Group
36 1
42 1
Overall Study
Classroom 5 in Each Study Group
41 1
37 1
Overall Study
Classroom 6 in Each Study Group
40 1
39 1
Overall Study
Classroom 7 in Each Study Group
43 1
41 1
Overall Study
Classroom 8 in Each Study Group
40 1
38 1
Overall Study
COMPLETED
312 8
312 8
Overall Study
NOT COMPLETED
7 0
5 0

Reasons for withdrawal

Reasons for withdrawal
Measure
Comparison Group, Online Oral Health Education Group
In this study group, participants received online oral health education session by logging in their Microsoft teams accounts. The intervention applied during the online oral health education session was in a form of pre-recorded cartoon presentation created by Prezi software.
Control Group, Conventional Oral Health Education Group
In this study group, participants received face-to-face oral health education session live inside their classrooms. The intervention applied during the conventional oral health education session was a live demo on toothbrushing techniques and a cartoon presentation created by using Prezi software.
Overall Study
Lost to Follow-up
7
5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control Group, Conventional Oral Health Education Group
n=312 Participants
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.
Comparison Group, Online Oral Health Education Group
n=312 Participants
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.
Total
n=624 Participants
Total of all reporting groups
Age, Categorical
<=18 years
312 Participants
n=312 Participants
312 Participants
n=312 Participants
624 Participants
n=624 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=312 Participants
0 Participants
n=312 Participants
0 Participants
n=624 Participants
Age, Categorical
>=65 years
0 Participants
n=312 Participants
0 Participants
n=312 Participants
0 Participants
n=624 Participants
Sex: Female, Male
Female
165 Participants
n=312 Participants
150 Participants
n=312 Participants
315 Participants
n=624 Participants
Sex: Female, Male
Male
147 Participants
n=312 Participants
162 Participants
n=312 Participants
309 Participants
n=624 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Egypt
312 participants
n=312 Participants
312 participants
n=312 Participants
624 participants
n=624 Participants

PRIMARY outcome

Timeframe: 2 months

Population: all participants in both arms received oral health education session through colorful images and cartoons.

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.

Outcome measures

Outcome measures
Measure
Control Group, Conventional Oral Health Education Group
n=312 Participants
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.
Comparison Group, Online Oral Health Education Group
n=312 Participants
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.
Effect of Oral Health Education on the Oral Health Knowledge in Primary School Children Aged 7-9 Years Old
2.71 knowledge score on a scale
Standard Deviation 1.53
0.81 knowledge score on a scale
Standard Deviation 1.16

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Control Group, Conventional Oral Health Education Group
n=312 Participants
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.
Comparison Group, Online Oral Health Education Group
n=312 Participants
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.
Effect of Oral Health Education on Oral Hygiene Measures Practice in Primary School Children Aged 7-9 Years Old
participants who brushed their teeth two times or more
224 Participants
208 Participants
Effect of Oral Health Education on Oral Hygiene Measures Practice in Primary School Children Aged 7-9 Years Old
participants who brushed less than two times or forgot to brush their teeth
84 Participants
97 Participants
Effect of Oral Health Education on Oral Hygiene Measures Practice in Primary School Children Aged 7-9 Years Old
participants who dont brush their teeth
4 Participants
7 Participants

Adverse Events

Control Group, Conventional Oral Health Education Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Comparison Group, Online Oral Health Education Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Omar Alaa Taqa

Ain Shams University

Phone: 01001454416

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place