SARS-CoV2NCT04592510
Impact of COVID-19 on Pediatric Dental Practice During First, Second And Third Wave.
An observational study of SARS-CoV2, run by Cairo University at 1 site in Egypt.
Trial summary
Assessment of impact of covid-19 on pediatric dental practice during first, second and third wave among a group of pediatric dentists. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SARS-CoV2
- How many people
- 345 participants
- Where
- 1 siteEgypt
- Study dates
- 25 May 2021to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Egyptian pediatric dentists regardless of their place of work, in either private clinics or educational hospitals.
Who may be able to join
- Egyptian pediatric dentists with at least Master's degree.
- Work place located in Egypt.
Who cannot join
- Participants who refuse to participate.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and Dental Medicine, Cairo University
Cairo, 11865
About this study
Official title: Impact of COVID-19 on Pediatric Dental Practice During First, Second And Third Wave Among a Group of Pediatric Dentists : A Cross -Sectional Study
Assessment of impact of covid-19 on pediatric dental practice during first, second and third wave among a group of pediatric dentists.
Read the detailed description
On the 11th of March, 2020, COVID-19 (SARS-CoV-2) was declared as a pandemic by the World Health Organization. SARS-CoV-2 is an unpredictable virus that is rapidly transmitting from one country to another, and unfortunately as of today, there is no effective medication or vaccine for the disease control. This virus has gone on to cause one of the most rapidly expanding pandemics with over 9 million people being infected worldwide including the pediatric population.
Due to the unique nature of dentistry, most dental procedures generate significant amounts of droplets and aerosols, posing potential risks of infection transmission. Recent studies have demonstrated the role of the oral mucosa in COVID-19 infection, in addition to expressing the ACE2 receptor in salivary glands in the asymptomatic process in infected saliva, thus being one of the main sources of viruses.
Clinical features of COVID-19 in children include fever and cough, but a large proportion of infected children appears to be asymptomatic and may contribute significantly to transmission. Therefore, it can be assumed that, at this stage in the pandemic, all children and their parents/carers are potentially infective with the potential of cross-infection to dental stuff, parents and the public. This has, in theory, an impact on medical and dental procedures that are Aerosol Generating Procedures.
- Conditions
- SARS-CoV2
- Keywords
- COVID-19, pediatric dentistry
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitude of pediatric dentists toward treating patients in time of COVID-19.
Measuring device by Questionnaire (Ahmadi, Ebrahimi \& Ghorbani, 2020) and (Sinjari et al., 2020). The primary outcome is measured using 5-point likert scale scoring to evaluate pediatric dentists' attitudes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start25 May 2021
- Primary completionOct 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV2Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 345 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Essam El-Deen Abdel Rahim, Cairo University
- Investigators
- Adel El Bardissy, Study director, Faculty of Oral and dental medicine, Cairo universityShaimaa Sabry, Study chair, Faculty of Oral and dental medicine, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592510
- Sponsor's protocol ID
- y66cyyg6
- Status last verified
- Jun 2021
- First submitted
- 16 Oct 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahmadi H, Ebrahimi A, Ghorbani F. The impact of COVID-19 pandemic on dental practice in Iran: a questionnaire-based report. BMC Oral Health. 2020 Dec 3;20(1):354. doi: 10.1186/s12903-020-01341-x.
PubMed 33272261Al-Halabi M, Salami A, Alnuaimi E, Kowash M, Hussein I. Assessment of paediatric dental guidelines and caries management alternatives in the post COVID-19 period. A critical review and clinical recommendations. Eur Arch Paediatr Dent. 2020 Oct;21(5):543-556. doi: 10.1007/s40368-020-00547-5. Epub 2020 Jun 16.
PubMed 32557183BaniHani A, Gardener C, Raggio DP, Santamaria RM, Albadri S. Could COVID-19 change the way we manage caries in primary teeth? Current implications on Paediatric Dentistry. Int J Paediatr Dent. 2020 Sep;30(5):523-525. doi: 10.1111/ipd.12690. No abstract available.
PubMed 32722881Cook TM. Personal protective equipment during the coronavirus disease (COVID) 2019 pandemic - a narrative review. Anaesthesia. 2020 Jul;75(7):920-927. doi: 10.1111/anae.15071. Epub 2020 Apr 28.
PubMed 32246849Dong Y, Mo X, Hu Y, Qi X, Jiang F, Jiang Z, Tong S. Epidemiology of COVID-19 Among Children in China. Pediatrics. 2020 Jun;145(6):e20200702. doi: 10.1542/peds.2020-0702. Epub 2020 Mar 16.
PubMed 32179660Frauenfelder C, Butler C, Hartley B, Cochrane L, Jephson C, Nash R, Hewitt R, Albert D, Wyatt M, Hall A. Practical insights for paediatric otolaryngology surgical cases and performing microlaryngobronchoscopy during the COVID-19 pandemic. Int J Pediatr Otorhinolaryngol. 2020 Jul;134:110030. doi: 10.1016/j.ijporl.2020.110030. Epub 2020 Mar 30.
PubMed 32278168Qiu H, Wu J, Hong L, Luo Y, Song Q, Chen D. Clinical and epidemiological features of 36 children with coronavirus disease 2019 (COVID-19) in Zhejiang, China: an observational cohort study. Lancet Infect Dis. 2020 Jun;20(6):689-696. doi: 10.1016/S1473-3099(20)30198-5. Epub 2020 Mar 25.
PubMed 32220650Sinjari B, Rexhepi I, Santilli M, D Addazio G, Chiacchiaretta P, Di Carlo P, Caputi S. The Impact of COVID-19 Related Lockdown on Dental Practice in Central Italy-Outcomes of A Survey. Int J Environ Res Public Health. 2020 Aug 10;17(16):5780. doi: 10.3390/ijerph17165780.
PubMed 32785056Sundaram M, Ravikumar N, Bansal A, Nallasamy K, Basavaraja GV, Lodha R, Gupta D, Odena MP, Ashwath RNR, Jayashree M; Intensive Care Chapter of Indian Academy of Pediatrics. Novel Coronavirus 2019 (2019-nCoV) Infection: Part II - Respiratory Support in the Pediatric Intensive Care Unit in Resource-limited Settings. Indian Pediatr. 2020 Apr 15;57(4):335-342. doi: 10.1007/s13312-020-1786-x. Epub 2020 Mar 29.
PubMed 32238613Xu J, Li Y, Gan F, Du Y, Yao Y. Salivary Glands: Potential Reservoirs for COVID-19 Asymptomatic Infection. J Dent Res. 2020 Jul;99(8):989. doi: 10.1177/0022034520918518. Epub 2020 Apr 9. No abstract available.
PubMed 32271653
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 on Pediatric Dental Practice During First, Second And Third Wave Among a Group of Pediatric Dentists : A Cross -Sectional Study
- ClinicalTrials.gov ID
- NCT04592510
- Acronym / sponsor ID
- y66cyyg6
- Conditions
- SARS-CoV2
- Keywords
- COVID-19, pediatric dentistry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of impact of covid-19 on pediatric dental practice during first, second and third wave among a group of pediatric dentists.
Detailed description
On the 11th of March, 2020, COVID-19 (SARS-CoV-2) was declared as a pandemic by the World Health Organization. SARS-CoV-2 is an unpredictable virus that is rapidly transmitting from one country to another, and unfortunately as of today, there is no effective medication or vaccine for the disease control. This virus has gone on to cause one of the most rapidly expanding pandemics with over 9 million people being infected worldwide including the pediatric population.
Due to the unique nature of dentistry, most dental procedures generate significant amounts of droplets and aerosols, posing potential risks of infection transmission. Recent studies have demonstrated the role of the oral mucosa in COVID-19 infection, in addition to expressing the ACE2 receptor in salivary glands in the asymptomatic process in infected saliva, thus being one of the main sources of viruses.
Clinical features of COVID-19 in children include fever and cough, but a large proportion of infected children appears to be asymptomatic and may contribute significantly to transmission. Therefore, it can be assumed that, at this stage in the pandemic, all children and their parents/carers are potentially infective with the potential of cross-infection to dental stuff, parents and the public. This has, in theory, an impact on medical and dental procedures that are Aerosol Generating Procedures.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Egyptian pediatric dentists regardless of their place of work, in either private clinics or educational hospitals.
Key inclusion criteria (2 listed)
- Egyptian pediatric dentists with at least Master's degree.
- Work place located in Egypt.
Key exclusion criteria (1 listed)
- Participants who refuse to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Attitude of pediatric dentists toward treating patients in time of COVID-19.
Time frame: 6 months
Measuring device by Questionnaire (Ahmadi, Ebrahimi \& Ghorbani, 2020) and (Sinjari et al., 2020). The primary outcome is measured using 5-point likert scale scoring to evaluate pediatric dentists' attitudes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Background: PubMed 33272261Ahmadi H, Ebrahimi A, Ghorbani F. The impact of COVID-19 pandemic on dental practice in Iran: a questionnaire-based report. BMC Oral Health. 2020 Dec 3;20(1):354. doi: 10.1186/s12903-020-01341-x.
- Background: PubMed 32557183Al-Halabi M, Salami A, Alnuaimi E, Kowash M, Hussein I. Assessment of paediatric dental guidelines and caries management alternatives in the post COVID-19 period. A critical review and clinical recommendations. Eur Arch Paediatr Dent. 2020 Oct;21(5):543-556. doi: 10.1007/s40368-020-00547-5. Epub 2020 Jun 16.
- Background: PubMed 32722881BaniHani A, Gardener C, Raggio DP, Santamaria RM, Albadri S. Could COVID-19 change the way we manage caries in primary teeth? Current implications on Paediatric Dentistry. Int J Paediatr Dent. 2020 Sep;30(5):523-525. doi: 10.1111/ipd.12690. No abstract available.
- Background: PubMed 32246849Cook TM. Personal protective equipment during the coronavirus disease (COVID) 2019 pandemic - a narrative review. Anaesthesia. 2020 Jul;75(7):920-927. doi: 10.1111/anae.15071. Epub 2020 Apr 28.
- Background: PubMed 32179660Dong Y, Mo X, Hu Y, Qi X, Jiang F, Jiang Z, Tong S. Epidemiology of COVID-19 Among Children in China. Pediatrics. 2020 Jun;145(6):e20200702. doi: 10.1542/peds.2020-0702. Epub 2020 Mar 16.
- Background: PubMed 32278168Frauenfelder C, Butler C, Hartley B, Cochrane L, Jephson C, Nash R, Hewitt R, Albert D, Wyatt M, Hall A. Practical insights for paediatric otolaryngology surgical cases and performing microlaryngobronchoscopy during the COVID-19 pandemic. Int J Pediatr Otorhinolaryngol. 2020 Jul;134:110030. doi: 10.1016/j.ijporl.2020.110030. Epub 2020 Mar 30.
- Background: PubMed 32220650Qiu H, Wu J, Hong L, Luo Y, Song Q, Chen D. Clinical and epidemiological features of 36 children with coronavirus disease 2019 (COVID-19) in Zhejiang, China: an observational cohort study. Lancet Infect Dis. 2020 Jun;20(6):689-696. doi: 10.1016/S1473-3099(20)30198-5. Epub 2020 Mar 25.
- Background: PubMed 32785056Sinjari B, Rexhepi I, Santilli M, D Addazio G, Chiacchiaretta P, Di Carlo P, Caputi S. The Impact of COVID-19 Related Lockdown on Dental Practice in Central Italy-Outcomes of A Survey. Int J Environ Res Public Health. 2020 Aug 10;17(16):5780. doi: 10.3390/ijerph17165780.
- Background: PubMed 32238613Sundaram M, Ravikumar N, Bansal A, Nallasamy K, Basavaraja GV, Lodha R, Gupta D, Odena MP, Ashwath RNR, Jayashree M; Intensive Care Chapter of Indian Academy of Pediatrics. Novel Coronavirus 2019 (2019-nCoV) Infection: Part II - Respiratory Support in the Pediatric Intensive Care Unit in Resource-limited Settings. Indian Pediatr. 2020 Apr 15;57(4):335-342. doi: 10.1007/s13312-020-1786-x. Epub 2020 Mar 29.
- Background: PubMed 32271653Xu J, Li Y, Gan F, Du Y, Yao Y. Salivary Glands: Potential Reservoirs for COVID-19 Asymptomatic Infection. J Dent Res. 2020 Jul;99(8):989. doi: 10.1177/0022034520918518. Epub 2020 Apr 9. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adel El Bardissy study director
Faculty of Oral and dental medicine, Cairo university
Shaimaa Sabry study chair
Faculty of Oral and dental medicine, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV2, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Essam El-Deen (01150035515, fatma_essam@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attitude of pediatric dentists toward treating patients in time of COVID-19. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04592510, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.