Effect of PPE on Children's Fear in Dental Office

NCT ID: NCT05371561

Last Updated: 2022-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-05-01

Brief Summary

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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

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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.

Conditions

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COVID-19 Infections COVID-19 Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
Participants, legal guardians, and the dentist who carried out the examination were not blinded as it was inapplicable. The accessor and statistician were blinded

Study Groups

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Goggles + surgical mask

Dentist wearing Goggles + surgical mask will examin the patient

Group Type ACTIVE_COMPARATOR

reusable respirators

Intervention Type DEVICE

Dentist wearing reusable respirator will examin the patient

Face shield+ surgical mask

Dentist wearing Face shield+ surgical mask will examin the patient

Group Type ACTIVE_COMPARATOR

reusable respirators

Intervention Type DEVICE

Dentist wearing reusable respirator will examin the patient

Half face reusable respirator+ Filter

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

Group Type EXPERIMENTAL

reusable respirators

Intervention Type DEVICE

Dentist wearing reusable respirator will examin the patient

Full face reusable respirator+ Filter

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

Group Type EXPERIMENTAL

reusable respirators

Intervention Type DEVICE

Dentist wearing reusable respirator will examin the patient

Interventions

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reusable respirators

Dentist wearing reusable respirator will examin the patient

Intervention Type DEVICE

Eligibility Criteria

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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,
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fayoum University

OTHER

Sponsor Role lead

Responsible Party

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Maha Moussa Azab

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Fayoum university

Al Fayyum, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 36138354 (View on PubMed)

Other Identifiers

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Fayoum U

Identifier Type: -

Identifier Source: org_study_id

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