Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-28 @ 1:32 PM
Study NCT ID:
NCT05371561
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2022-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of PPE on Children's Fear in Dental Office
Sponsor:
Fayoum University
Organization:
Study Overview
Official Title:
Influence of Different Personal Protective Equipment on Children's Fear in Dental Office: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: