Effect of PPE on Children's Fear in Dental Office

May 11, 2022 updated by: Maha Moussa Azab, Fayoum University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt
        • Faculty of dentistry, Fayoum University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arabic version of children's fear survey schedule-dental subscale (CFSS-DS)
Time Frame: 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
just after examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fayoum U

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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