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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04815759
Other study ID # Dental anxiety
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date April 30, 2021

Study information

Verified date March 2021
Source Alexandria University
Contact Dalia M Talaat, phd
Phone 01221037275
Email dalia.talaat@dent.alex.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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


Recruitment information / eligibility

Status Recruiting
Enrollment 82
Est. completion date April 30, 2021
Est. primary completion date April 27, 2021
Accepts healthy volunteers
Gender All
Age group 4 Years to 6 Years
Eligibility Inclusion Criteria: - parental consent - no previous dental experience - medically free children Exclusion Criteria: - children with negative behavior according to Frankl Rating Scale - children require general anesthesia

Study Design


Related Conditions & MeSH terms


Intervention

Other:
routine dental restorative procedures
pulp and restorative therapy

Locations

Country Name City State
Egypt Faculty of Dentistry, Alexandria University Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
through study completion, an average of 3 months
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