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NCT05371561 Clinical Trial

Effect of PPE on Children's Fear in Dental Office

COVID-19 Clinical Trial

Official title:
Influence of Different Personal Protective Equipment on Children's Fear in Dental Office: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05371561
Other study ID # Fayoum U
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date May 1, 2022

Study information
Verified date May 2022
Source Fayoum University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the aim of the current study is to compare the effect of conventional facial PPE as 1)goggles + surgical masks, and 2)face shields + surgical masks versus 3)half-face and 4)full-face reusable respirators; on preoperative child's fear in the dental office.

Description:

Each patient meeting the inclusion criteria and assigned to a specific study group will enter the clinic for dental examination. The examining dentist, wearing the selected PPE will communicate with patient and parent, taking personal, previous and current history, and carrying out simple examination not involving the use of sharp instruments, provoking pain or investigations as radiographs. The process should take from three to five minutes. Then, the child will be escorted to another room to meet a blinded accessor, where he assesses the child's anxiety using the Arabic version of children's fear survey schedule-dental subscale CFSS-DS.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date May 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Years to 10 Years
Eligibility Inclusion Criteria: - Six to ten-year-old patients Exclusion Criteria: - emergency patients - patients who have systemic, mental or psychological conditions as indicated by their medical history,

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• reusable respirators
Dentist wearing reusable respirator will examin the patient

Locations
Country Name City State
Egypt Faculty of Dentistry, Fayoum university Fayoum

Sponsors (1)
Lead Sponsor Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Arabic version of children's fear survey schedule-dental subscale (CFSS-DS) Children's fear survey schedule-dental subscale CFSS-DS is a tool to measure children's anxiety in dental settings. The CFSS-DS consists of 15 items, revolving around dental setting and procedures, child will answer each item by choosing a rate from a 5-point Likert scale that ranges from 1 ('not afraid at all') to 5 ('very afraid'), the total score should range from 15 to 75 just after examination
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