Effect of PPE on Children's Fear in Dental Office

Sponsor

Fayoum University (Other)

Overall Status

Completed

CT.gov ID

NCT05371561

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

52.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Infections COVID-19 Virus Infection	Device: reusable respirators	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Actual Primary Completion Date :

May 1, 2022

Actual Study Completion Date :

May 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Arabic version of children's fear survey schedule-dental subscale (CFSS-DS) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 10 Years

Sexes Eligible for Study:

All

Accepts 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,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Fayoum university	Fayoum		Egypt

Sponsors and Collaborators

Fayoum University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maha Moussa Azab, Lecturer, Fayoum University

ClinicalTrials.gov Identifier:

NCT05371561

Other Study ID Numbers:

Fayoum U

First Posted:

May 12, 2022

Last Update Posted:

May 18, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maha Moussa Azab, Lecturer, Fayoum University

Additional relevant MeSH terms:

Infections

Communicable Diseases

COVID-19

Study Results

No Results Posted as of May 18, 2022