Effect of PPE on Children's Fear in Dental Office
Influence of Different Personal Protective Equipment on Children's Fear in Dental Office: A Randomized Controlled Trial
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Apr 2022
Shorter than P25 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 9, 2022
CompletedFirst Posted
Study publicly available on registry
May 12, 2022
CompletedMay 18, 2022
May 1, 2022
1 month
May 9, 2022
May 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Goggles + surgical mask
ACTIVE COMPARATORDentist wearing Goggles + surgical mask will examin the patient
Face shield+ surgical mask
ACTIVE COMPARATORDentist wearing Face shield+ surgical mask will examin the patient
Half face reusable respirator+ Filter
EXPERIMENTALDentist wearing Half face reusable respirator+ Filter will examin the patient
Full face reusable respirator+ Filter
EXPERIMENTALDentist wearing Full face reusable respirator+ Filter will examin the patient
Interventions
Dentist wearing reusable respirator will examin the patient
Eligibility Criteria
You may qualify if:
- Six to ten-year-old patients
You may not qualify if:
- emergency patients
- patients who have systemic, mental or psychological conditions as indicated by their medical history,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, Fayoum university
Al Fayyum, Egypt
Related Publications (1)
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.
PMID: 36138354DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants, legal guardians, and the dentist who carried out the examination were not blinded as it was inapplicable. The accessor and statistician were blinded
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
May 9, 2022
First Posted
May 12, 2022
Study Start
April 1, 2022
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
May 18, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share