Effect of PPE on Children's Fear in Dental Office

Not Applicable

Completed

• Conditions: Infections; COVID-19 Virus Infection; COVID-19
• Interventions: Device: reusable respirators

• Registration Number: NCT05371561
• Lead Sponsor: Fayoum University

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 Timeline

• Study Start: 2022-04-01
• Status Verified: 2022-05
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-11
• Last Update Submitted: 2022-05-11
• Study First Posted: 2022-05-12
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face shield+ surgical mask	reusable respirators	Dentist wearing Face shield+ surgical mask will examin the patient
Half face reusable respirator+ Filter	reusable respirators	Dentist wearing Half face reusable respirator+ Filter will examin the patient
Full face reusable respirator+ Filter	reusable respirators	Dentist wearing Full face reusable respirator+ Filter will examin the patient
Goggles + surgical mask	reusable respirators	Dentist wearing Goggles + surgical mask will examin the patient

Primary Outcome Measures

Name	Time	Method
Arabic version of children's fear survey schedule-dental subscale (CFSS-DS)	just after examination	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

Trial Locations

Locations (1)

Faculty of Dentistry, Fayoum university; 🇪🇬 Fayoum, Egypt