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
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
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
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
We'll reach out to this number within 24 hrs