Effect of PPE on Children's Fear in Dental Office

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID-19, Infections, COVID-19 Virus Infection

Intervention / Treatment
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* Device: reusable respirators


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Goggles + surgical mask<br>Dentist wearing Goggles + surgical mask will examin the patient | Device: reusable respirators<br>* Dentist wearing reusable respirator will examin the patient<br>|
| Active Comparator: Face shield+ surgical mask<br>Dentist wearing Face shield+ surgical mask will examin the patient | Device: reusable respirators<br>* Dentist wearing reusable respirator will examin the patient<br>|
| Experimental: Half face reusable respirator+ Filter<br>Dentist wearing Half face reusable respirator+ Filter will examin the patient | Device: reusable respirators<br>* Dentist wearing reusable respirator will examin the patient<br>|
| Experimental: Full face reusable respirator+ Filter<br>Dentist wearing Full face reusable respirator+ Filter will examin the patient | Device: reusable respirators<br>* Dentist wearing reusable respirator will examin the patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PPE, Dentist attire, Child behavior, dental fear