COVID-19 PandemicNCT06352580
Covid-19 Pandemic and Pediatric Dentistry
An observational study of COVID-19 Pandemic, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Coronavirus (SARS-CoV-2), which emerged in Wuhan, China in 2019 and causes severe respiratory infection, poses a potential risk for dentists and patients during dental treatments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- Survey
- Type of treatment
- Vaccines
- How many people
- 438 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 30 Jun 2022
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The families of the patients who came to the pediatric dentistry clinic were randomly selected from those who met the study criteria.
Who may be able to join
- Being over 18 years old
- Volunteering for the study
- Being mentally healthy
- Parents who apply to the paediatric dentistry clinic for the treatment of their child aged 0-14 years
- Being able to read and understand Turkish
- Being a citizen of the Republic of Turkey
Who cannot join
- The patient is not accompanied by a parent
- Not being able to read and understand Turkish
- Not volunteering for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parents' Approach to Dental Treatment of Their Children in the Presence of Covid-19 Infection and Vaccine: A Pediatric Perspective
Coronavirus (SARS-CoV-2), which emerged in Wuhan, China in 2019 and causes severe respiratory infection, poses a potential risk for dentists and patients during dental treatments. It is a common situation during the pandemic period for parents of children needing dental treatment to want to postpone their children's treatment due to Covid-19. This study aimed to evaluate parents' concerns about their children's dentist appointments and ongoing dental treatments in the presence of the quarantine imposed due to Covid-19 and the Covid-19 vaccines that have started to be administered worldwide. In the study, an informative survey consisting of 26 questions was applied to determine how parents feel about the COVID-19 pandemic, how concerned they are about their children's oral health and dental treatment plan, and the changes caused by COVID-19 vaccination practices. The questions were created by 3 different experienced dentists and analysed by 2 different experienced dentists. Questions 7 and 26 were repeated at the beginning and end of the survey to give the same question and answer meaning. Thus, the reliability of the survey was tested.
Read the detailed description
This study was carried out on the parents of pediatric patients who applied to Bolu Abant İzzet Baysal University Faculty of Dentistry, Department of Pediatric Dentistry between 2022 March and 2022 June. Ethical approval of the study was approved by Bolu Abant İzzet Baysal University Clinical Research Ethics Committee (Ethics Number 2022/12). In the study, an informative survey consisting of 26 questions was applied to determine how parents feel about the COVID-19 pandemic, how concerned they are about their children's oral health and dental treatment plan, and the changes caused by COVID-19 vaccination practices (Table 1). It was aimed to apply a survey to all parents of patients who fulfilled the inclusion criteria after ethics committee approval was obtained, provided that at least 400 participants were provided.
Inclusion Criteria Being over 18 years old Volunteering for the study Being mentally healthy Parents who apply to the paediatric dentistry clinic for the treatment of their child aged 0-14 years Being able to read and understand Turkish Being a citizen of the Republic of Turkey Exclusion Criteria The patient is not accompanied by a parent Not being able to read and understand Turkish Not volunteering for the study The questions were created by 3 different experienced dentists and analysed by 2 different experienced dentists. Participants were asked questions such as their age, gender, city of residence, whether they had symptoms related to COVID-19, whether they had received dental treatment, and whether they had been vaccinated against COVID-19, and if so, which vaccine they preferred and why. In terms of the reliability of the comprehensibility of the survey, Questions 7 and 26 were repeated at the beginning and end of the survey to give the same question and answer meaning. Thus, the reliability of the survey was tested.
Statistical Analysis In this study, the relationships between categorical data were analysed by Pearson's Chi-squared Test when the sample size assumption was met (n<5) and by Fisher's Exact test when it was not met. Multiple Chi-Square test was used to investigate the relationship between multiple-choice questions. Analyses were performed in IBM SPSS 25 programme. P<0.05 was considered statistically significant.
- Conditions
- COVID-19 Pandemic
- Being tested
- Survey
- Keywords
- Covid-19 Pandemic, Covid-19 Vaccine, Pediatric dental treatments, Dentist visit
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
26 survey questions were administered face to face to parents, which they could answer in a short time.
| Study group | Role | What they receive |
|---|---|---|
| Parents | It was aimed for the parents of pediatric patients to fill out the survey consisting of 26 questions. The questions were about the Covid-19 Pandemic, Covid-19 vaccines and their approach to their children's dental treatment during the Covid-19 Pandemic. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Approach to dental treatments
How did parents approach their children's dental treatment needs in the presence of the Covid-19 pandemic?
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Mar 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 438 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Sila ÖZDEMİR CELİK, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352580
- Sponsor's protocol ID
- COVID-19 Pediatric
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents' Approach to Dental Treatment of Their Children in the Presence of Covid-19 Infection and Vaccine: A Pediatric Perspective
- ClinicalTrials.gov ID
- NCT06352580
- Acronym / sponsor ID
- COVID-19 Pediatric
- Conditions
- COVID-19 Pandemic
- Keywords
- Covid-19 Pandemic, Covid-19 Vaccine, Pediatric dental treatments, Dentist visit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 8 Apr 2024 (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.
Coronavirus (SARS-CoV-2), which emerged in Wuhan, China in 2019 and causes severe respiratory infection, poses a potential risk for dentists and patients during dental treatments. It is a common situation during the pandemic period for parents of children needing dental treatment to want to postpone their children's treatment due to Covid-19. This study aimed to evaluate parents' concerns about their children's dentist appointments and ongoing dental treatments in the presence of the quarantine imposed due to Covid-19 and the Covid-19 vaccines that have started to be administered worldwide. In the study, an informative survey consisting of 26 questions was applied to determine how parents feel about the COVID-19 pandemic, how concerned they are about their children's oral health and dental treatment plan, and the changes caused by COVID-19 vaccination practices. The questions were created by 3 different experienced dentists and analysed by 2 different experienced dentists. Questions 7 and 26 were repeated at the beginning and end of the survey to give the same question and answer meaning. Thus, the reliability of the survey was tested.
Detailed description
This study was carried out on the parents of pediatric patients who applied to Bolu Abant İzzet Baysal University Faculty of Dentistry, Department of Pediatric Dentistry between 2022 March and 2022 June. Ethical approval of the study was approved by Bolu Abant İzzet Baysal University Clinical Research Ethics Committee (Ethics Number 2022/12). In the study, an informative survey consisting of 26 questions was applied to determine how parents feel about the COVID-19 pandemic, how concerned they are about their children's oral health and dental treatment plan, and the changes caused by COVID-19 vaccination practices (Table 1). It was aimed to apply a survey to all parents of patients who fulfilled the inclusion criteria after ethics committee approval was obtained, provided that at least 400 participants were provided.
Inclusion Criteria Being over 18 years old Volunteering for the study Being mentally healthy Parents who apply to the paediatric dentistry clinic for the treatment of their child aged 0-14 years Being able to read and understand Turkish Being a citizen of the Republic of Turkey Exclusion Criteria The patient is not accompanied by a parent Not being able to read and understand Turkish Not volunteering for the study The questions were created by 3 different experienced dentists and analysed by 2 different experienced dentists. Participants were asked questions such as their age, gender, city of residence, whether they had symptoms related to COVID-19, whether they had received dental treatment, and whether they had been vaccinated against COVID-19, and if so, which vaccine they preferred and why. In terms of the reliability of the comprehensibility of the survey, Questions 7 and 26 were repeated at the beginning and end of the survey to give the same question and answer meaning. Thus, the reliability of the survey was tested.
Statistical Analysis In this study, the relationships between categorical data were analysed by Pearson's Chi-squared Test when the sample size assumption was met (n<5) and by Fisher's Exact test when it was not met. Multiple Chi-Square test was used to investigate the relationship between multiple-choice questions. Analyses were performed in IBM SPSS 25 programme. P<0.05 was considered statistically significant.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents | – | Other: SurveyIt was aimed for the parents of pediatric patients to fill out the survey consisting of 26 questions. The questions were about the Covid-19 Pandemic, Covid-19 vaccines and their approach to their children's dental treatment during the Covid-19 Pandemic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The families of the patients who came to the pediatric dentistry clinic were randomly selected from those who met the study criteria.
Key inclusion criteria (6 listed)
- Being over 18 years old
- Volunteering for the study
- Being mentally healthy
- Parents who apply to the paediatric dentistry clinic for the treatment of their child aged 0-14 years
- Being able to read and understand Turkish
Key exclusion criteria (3 listed)
- The patient is not accompanied by a parent
- Not being able to read and understand Turkish
- Not volunteering for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey26 survey questions were administered face to face to parents, which they could answer in a short time. | Other | Parents |
Primary outcome
Approach to dental treatments
Time frame: 3 months
How did parents approach their children's dental treatment needs in the presence of the Covid-19 pandemic?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 Pandemic, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 8 Apr 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Approach to dental treatments (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2024.