Dental AnxietyNCT04815759
Dental Anxiety Among Children Pre and Post COVID 19 Pandemic
An observational study of Dental Anxiety, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Dental fear and anxiety is a significant issue that affects pediatric patients and creates challenges in oral health management. Considering that the coronavirus disease 2019 (COVID-19) pandemic, along with its associated sanitary regime, social distancing measures and nationwide quarantines, could itself induce… Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- routine dental restorative procedures
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 30 Apr 2021
- 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 4 to 6 years
- All sexes
- Child
Study population: children with an age range 4-6 years attending the outpatient clinic of the of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University
Who may be able to join
- parental consent
- no previous dental experience
- medically free children
Who cannot join
- children with negative behavior according to Frankl Rating Scale
- children require general anesthesia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Alexandria University
Alexandria
Dalia M Talaat, 01221037275
About this study
Official title: Dental Anxiety Among Egyptian Children Pre and Post COVID 19
Dental fear and anxiety is a significant issue that affects pediatric patients and creates challenges in oral health management. Considering that the coronavirus disease 2019 (COVID-19) pandemic, along with its associated sanitary regime, social distancing measures and nationwide quarantines, could itself induce public fears, including in children, it is of great interest to explore whether this situation and the necessity of reorganizing dental care could potentially affect the emotional state of pediatric patients facing a need for urgent dental intervention
- Conditions
- Dental Anxiety
- Being tested
- routine dental restorative procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine dental restorative proceduresOther
pulp and restorative therapy
| Study group | Role | What they receive |
|---|---|---|
| Pre pandemic | Not described Receives: Other: routine dental restorative procedures | |
| Post pandemic | Not described Receives: Other: routine dental restorative procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental anxiety level
Assessment will performed by using Facial image scale (FIS)It consists of 5 faces ranging from very happy to very unhappy.
At the beginning, the 5 faces have been explained to all children and they were asked to point to the face which best describes how he/she felt at the moment
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Mar 2021
- Primary completion27 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815759
- Sponsor's protocol ID
- Dental anxiety
- Status last verified
- Mar 2021
- First submitted
- 20 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Anxiety Among Egyptian Children Pre and Post COVID 19
- ClinicalTrials.gov ID
- NCT04815759
- Acronym / sponsor ID
- Dental anxiety
- Conditions
- Dental Anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 27 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 25 Mar 2021 (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.
Dental fear and anxiety is a significant issue that affects pediatric patients and creates challenges in oral health management. Considering that the coronavirus disease 2019 (COVID-19) pandemic, along with its associated sanitary regime, social distancing measures and nationwide quarantines, could itself induce public fears, including in children, it is of great interest to explore whether this situation and the necessity of reorganizing dental care could potentially affect the emotional state of pediatric patients facing a need for urgent dental intervention
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre pandemic | – | Other: routine dental restorative procedures |
| Post pandemic | – | Other: routine dental restorative procedures |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- children with an age range 4-6 years attending the outpatient clinic of the of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University
Key inclusion criteria (3 listed)
- parental consent
- no previous dental experience
- medically free children
Key exclusion criteria (2 listed)
- children with negative behavior according to Frankl Rating Scale
- children require general anesthesia
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 |
|---|---|---|
| routine dental restorative procedurespulp and restorative therapy | Other | Post pandemic, Pre pandemic |
Primary outcome
Dental anxiety level
Time frame: through study completion, an average of 3 months
Assessment will performed by using Facial image scale (FIS)It consists of 5 faces ranging from very happy to very unhappy. At the beginning, the 5 faces have been explained to all children and they were asked to point to the face which best describes how he/she felt at the moment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
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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.
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 Dental Anxiety, run by Hams Hamed Abdelrahman 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 3 inclusion and 2 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 25 Mar 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 Dalia M Talaat, phd (01221037275, dalia.talaat@dent.alex.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental anxiety level (time frame: through study completion, an average of 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 25 Mar 2021.