Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05094739 |
| Other study ID # |
Covid 19 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2022 |
| Est. completion date |
February 2024 |
Study information
| Verified date |
June 2022 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
title: Knowledge and Attitude of a group of Egyptian Parents toward Dental Treatment of their
children during the Fourth Wave of COVID-19: A Cross Sectional Study.
aim: The aim of the study is to evaluate the knowledge and attitudes of a group of Egyptian
parents toward dental treatment of their children during the fourth wave of COVID-19
pandemic.
Description:
statement of the problem: COVID-19 is a global public health threat that affects the
respiratory system and threatens millions of lives all over the world. The World Health
Organization (WHO) declared on 30 Jan. 2020 that COVID-19 is a public health emergency
(Clouthard et al. 2020).
Fear from infection transmission from person to person or from contaminated objects increased
after emergence of COVID-19 as virus can survive in aerosols for 3 hours and on plastic and
stainless steel surfaces up to 3 days (Surme et al. 2021).
As dentistry is a profession with high risk for transmission of COVID-19, it is affected
greatly clinically and economically. Clinically as only cases which need immediate
interference like trauma and swellings that obstruct the airway can be done, and routine
dental care should be suspended. Economically this suspension of routine dental care causes
closure of number of dental clinics due to real financial problems, anxiety and stress
(Clouthard et al. 2020).
From patient's point of view, so many patients thought that dental clinics are dangerous
areas as source of risk of infection with COVID-19 (Surme et al. 2021).
Rationale:
Coronavirus disease 2019 (COVID-19) is a great threat to global public health. More than 260
million confirmed cases have been reported according to the statistics of the World Health
Organization (WHO), including over five million deaths. The original severe acute respiratory
syndrome coronavirus that was identified at the end of 2019 had evolved and a variety of
variants emerged. (WHO) has classified them into categories. Variants of concern include
Alpha, Beta, Gamma and Delta. They all resulted in a new wave of pandemic and thousands of
deaths. Lately a new variant named Omicron which immediately raised global concerns was
considered as the fifth variant of concern by WHO On November 26, 2021(He et al. 2021).
So people must be aware about Corona virus and its variants to avoid the infection.COVID-19
is a long standing pandemic as the virus continuously mutates and new variants emerge which
subsequently need new solutions.
Benefits:
1- Patient:
- Increasing awareness of patient and their parents toward COVID-19 and dentistry.
2- Practitioner:
- Increasing the knowledge about the parents' attitude towards dental treatment during
fourth wave of COVID-19 pandemic.
3- Community:
- Increasing the knowledge and awareness of the community about COVID-19 pandemic
(specially the fourth wave of COVID 19), and its relation with dentistry.
Aim of the study: is to evaluate the knowledge and attitudes of a group of Egyptian parents
toward dental treatment of their children during the fourth wave of COVID-19 pandemic.
PO format:
- P: A group of Egyptian parents.
- O: Knowledge and attitude of a group of Egyptian parents toward dental treatment of
their children during the fourth wave of COVID-19 pandemic.
Primary outcome: Knowledge and attitude of a group of Egyptian parents toward dental
treatment of their children during the fourth wave of COVID-19 pandemic.
Measurement method: Questionnaire by (Deema& Nada Farsi, 2021), Developed from ( Yip et al.
2007)& (Sun et al. 2020)
Unit of measurement:
- Binary question (Yes, No)
- Close-ended questions.
Secondary outcome:
1. Attitudes regarding taking children to see a dentist during the fourth wave of COVID-19
pandemic.
Measurement method: Questionnaire by (Deema& Nada Farsi, 2021) Developed from ( Yip et
al. 2007)& (Sun et al. 2020)
Unit of measurement:
-Binary question (Yes, No)
- Close-ended questions.
2. Attitudes regarding maintenance of next visits during fourth wave of COVID-19 pandemic.
Measurement method: Direct question
Unit of measurement:
-Binary question (Yes, No)
Methods:
A) Study design and setting.
- Study design Cross-sectional study
- Settings:
_ Location: Clinics of Paediatric dentistry and Dental Public Health Department,
Faculty of dentistry, Cairo University.
_ Methodology:
• The questionnaires will be distributed and filled under supervision of the
primary investigator.
• Each parent will be allowed to fulfill the questionnaire.
• The parents will answer the questions in the questionnaire (Arabic version).
• The questionnaire was developed from (Yip et al. 2007) & (Sun et al. 2020).
• The questionnaire was then modified and validated by (Deema& Nada Farsi, 2021).
• Then the author chose some of the questions of the questionnaire (with a reduced
number) to be matched with the concept of the study.
• All the questionnaires are translated into Arabic language
B) Participants
- Eligibility criteria and selection methods:
Inclusion criteria:
-Parents with at least intermediate education.
Exclusion criteria:
- Illiterate parents.
- Refusal of participation
C) Variables:
- Details about variables:
Primary outcome: Knowledge and attitude of a group of Egyptian parents toward dental
treatment of their children during the fourth wave of COVID-19 pandemic.
Measurement method: Questionnaire by (Deema& Nada Farsi, 2021), Developed from ( Yip et
al. 2007)& (Sun et al. 2020)
Unit of measurement:
-Binary question (Yes, No)
- Close-ended questions.
Secondary outcome:1- Attitudes regarding taking children to see a dentist during the
fourth wave of COVID-19 pandemic.
Measurement method: Questionnaire by (Deema& Nada Farsi, 2021) Developed from ( Yip et
al. 2007)& (Sun et al. 2020)
Unit of measurement:
-Binary question (Yes, No)
- Close-ended questions.
2- Attitudes regarding maintenance of next visits during fourth wave of COVID-19 pandemic.
Measurement method: Direct question
Unit of measurement:
-Binary question (Yes, No).
_Potential confounders: Age, sex, degree of awareness, degree of education, parental dental
anxiety due to COVID-19 Pandemic.
_Data sources and management:
Data will be obtained through written questionnaires for assessing Knowledge and Attitude of
a group of Egyptian Parents toward Dental Treatment of their children during the Fourth Wave
of COVID-19. Data collected will be saved and tabulated on computer for back up and finally
statistically analysed.
_ Addressing potential sources of bias:
Selection bias:
All parents fulfilling the inclusion criteria, attending the days of examination will be
included.
Information bias:
Information bias will be avoided by explaining to the parents the aim of the study without
guiding them to specific answers.
Reporting bias:
All outcomes will be reported.
D) Study size:
- Study size:
A power analysis was designed to have adequate power to apply a statistical test of the
research question regarding the knowledge and attitude of a group of Egyptian parents toward
dental treatment of their children during the fourth wave of COVID-19 pandemic. According to
the results of a previous study -in which the prevalence of good knowledge was (42.4%)- and
by adopting a confidence interval of (95%), a margin of error of (5%) with finite population
correction; The predicted sample size (n) was a total of (375) cases. Sample size calculation
was performed using Epi info for windows version 7.2 .
E) Quantitative variables :
-Handling of quantitative variables in the analysis Numerical data will be explored for
normality by checking the data distribution, calculating the mean and median values and using
Kolmogorov-Smirnov and Shapiro-Wilk tests. If the data was found to be normally distributed,
it will be presented as mean and standard deviation values. If the assumption of normality
was found to be violated, the data will be presented as median and range values.
Handling of categorical/ qualitative variables:
Categorical data will be represented as frequency (n) and percentage (%).
F) Statistical methods:
- Statistical methods: Categorical data will be represented as frequency (n) and percentage
(%) and will be analyzed using chi square test. Numerical data will be explored for normality
by checking the data distribution, calculating the mean and median values and using
Kolmogorov-Smirnov and Shapiro-Wilk tests. If the data was found to be normally distributed,
it will be presented as mean and standard deviation values and independent t-test will be
used for the analysis. If the assumption of normality was found to be violated; the data will
be presented as median and range values and will be analyzed using Mann-Whitney U test. The
significance level will be set at P ≤0.05 for all tests. Statistical analysis will be
performed with IBM SPSS Statistics Version 26 for Windows.
References:
1. Farsi, D., & Farsi, N. (2021). Mothers' Knowledge, Attitudes, and Fears About Dental
Visits During the COVID-19 Pandemic: A Cross-sectional Study. Journal of International
Society of Preventive & Community Dentistry, 11(1), 83.
2. Surme, K., Akman, H., Akbaydogan, L. C., & Akin, M. (2021). Evaluation of Parents'
Knowledge and Attitudes Towards Pediatric Dental Practice during the COVID-19 Pandemic.
Oral Health & Preventive Dentistry, 19(1), 271-277.
3. Sun, J., Xu, Y., Qu, Q., & Luo, W. (2020). Knowledge of and attitudes toward COVID-19
among parents of child dental patients during the outbreak. Brazilian oral research, 34.
4. Yip HK, Tsang PC, Samaranayake LP, Li AH. Knowledge of and attitudes toward severe acute
respiratory syndrome among a cohort of dental patients in Hong Kong following a major
local outbreak. Community Dent Health. 2007;24:43-8.
5. Barghout, N., Al Habashneh, R., Ryalat, S. T., Asa'ad, F. A., & Marashdeh, M. (2012).
Patients' perception of cross-infection prevention in dentistry in Jordan. Oral Health
and Preventive Dentistry, 10(1), 9.
6. World Health Organization. (2020). Coronavirus disease (COVID-19): How is it
transmitted. Geneva, Switzerland: WHO.
(
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub
/q-a-detail/coronavirus-disease-covid-19-how-is-it-transmitted)
7. World Health Organization. (2020). Coronavirus disease ( COVID-19). (
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub
/q-a-detail/coronavirus-disease-covid-19)
8. Coulthard, P., Thomson, P., Dave, M., Coulthard, F. P., Seoudi, N., & Hill, M. (2020).
The COVID-19 pandemic and dentistry: the clinical, legal and economic consequences-part
1: clinical. British Dental Journal, 229(11), 743-747.
9. Coulthard, P., Thomson, P., Dave, M., Coulthard, F. P., Seoudi, N., & Hill, M. (2020).
The COVID-19 pandemic and dentistry: the clinical, legal and economic consequences-part
2: consequences of withholding dental care. British Dental Journal, 229(12), 801-805.
10. He, X., Hong, W., Pan, X., Lu, G., & Wei, X. (2021). SARS-CoV-2 Omicron variant:
characteristics and prevention. MedComm.
(https://onlinelibrary.wiley.com/doi/full/10.1002/mco2.110)
11. Parvaie, P., & Osmani, F. (2022). Dentistry during COVID-19: patients' knowledge and
satisfaction toward health protocols COVID-19 during dental treatment. European journal
of medical research, 27(1), 1-7.
