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Effect of PPE on Children's Fear in Dental Office

Primary Purpose

COVID-19, Infections, COVID-19 Virus Infection

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
reusable respirators
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for COVID-19 focused on measuring PPE, Dentist attire, Child behavior, dental fear

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Faculty of Dentistry, Fayoum university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Goggles + surgical mask

Face shield+ surgical mask

Half face reusable respirator+ Filter

Full face reusable respirator+ Filter

Arm Description

Dentist wearing Goggles + surgical mask will examin the patient

Dentist wearing Face shield+ surgical mask will examin the patient

Dentist wearing Half face reusable respirator+ Filter will examin the patient

Dentist wearing Full face reusable respirator+ Filter will examin the patient

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 9, 2022
Last Updated
May 11, 2022
Sponsor
Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT05371561
Brief Title
Effect of PPE on Children's Fear in Dental Office
Official Title
Influence of Different Personal Protective Equipment on Children's Fear in Dental Office: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Infections, COVID-19 Virus Infection
Keywords
PPE, Dentist attire, Child behavior, dental fear

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Participants, legal guardians, and the dentist who carried out the examination were not blinded as it was inapplicable. The accessor and statistician were blinded
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Goggles + surgical mask
Arm Type
Active Comparator
Arm Description
Dentist wearing Goggles + surgical mask will examin the patient
Arm Title
Face shield+ surgical mask
Arm Type
Active Comparator
Arm Description
Dentist wearing Face shield+ surgical mask will examin the patient
Arm Title
Half face reusable respirator+ Filter
Arm Type
Experimental
Arm Description
Dentist wearing Half face reusable respirator+ Filter will examin the patient
Arm Title
Full face reusable respirator+ Filter
Arm Type
Experimental
Arm Description
Dentist wearing Full face reusable respirator+ Filter will examin the patient
Intervention Type
Device
Intervention Name(s)
reusable respirators
Intervention Description
Dentist wearing reusable respirator will examin the patient
Primary Outcome Measure Information:
Title
Arabic version of children's fear survey schedule-dental subscale (CFSS-DS)
Description
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
Time Frame
just after examination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Facility Information:
Facility Name
Faculty of Dentistry, Fayoum university
City
Fayoum
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36138354
Citation
Azab MM. Influence of different personal protective equipment on children's anxiety in dental office: a randomized controlled trial. BMC Oral Health. 2022 Sep 22;22(1):421. doi: 10.1186/s12903-022-02442-5.
Results Reference
derived

Learn more about this trial

Effect of PPE on Children's Fear in Dental Office

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