COVID-19NCT05371561
Effect of PPE on Children's Fear in Dental Office
A study testing reusable respirators in people with COVID-19 and Infections, run by Fayoum University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- COVID-19, Infections, COVID-19 Virus Infection
- What is being tested?
- reusable respirators
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Six to ten-year-old patients
Who cannot join
- emergency patients
- patients who have systemic, mental or psychological conditions as indicated by their medical history,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Infections, COVID-19 Virus Infection
- Being tested
- reusable respirators
- Keywords
- PPE, Dentist attire, Child behavior, dental fear
- Medical subject headings
- COVID-19, Infections, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reusable respiratorsDevice
Dentist wearing reusable respirator will examin the patient
| Study group | Role | What they receive |
|---|---|---|
| Goggles + surgical mask | Active comparator | Dentist wearing Goggles + surgical mask will examin the patient Receives: Device: reusable respirators |
| Face shield+ surgical mask | Active comparator | Dentist wearing Face shield+ surgical mask will examin the patient Receives: Device: reusable respirators |
| Half face reusable respirator+ Filter | Experimental | Dentist wearing Half face reusable respirator+ Filter will examin the patient Receives: Device: reusable respirators |
| Full face reusable respirator+ Filter | Experimental | Dentist wearing Full face reusable respirator+ Filter will examin the patient Receives: Device: reusable respirators |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: just after examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Apr 2022
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Moussa Azab, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371561
- Sponsor's protocol ID
- Fayoum U
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36138354
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Personal Protective Equipment on Children's Fear in Dental Office: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05371561
- Acronym / sponsor ID
- Fayoum U
- Conditions
- COVID-19, Infections, COVID-19 Virus Infection
- Keywords
- PPE, Dentist attire, Child behavior, dental fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Goggles + surgical mask | Active comparator | Device: reusable respiratorsDentist wearing Goggles + surgical mask will examin the patient |
| Face shield+ surgical mask | Active comparator | Device: reusable respiratorsDentist wearing Face shield+ surgical mask will examin the patient |
| Half face reusable respirator+ Filter | Experimental | Device: reusable respiratorsDentist wearing Half face reusable respirator+ Filter will examin the patient |
| Full face reusable respirator+ Filter | Experimental | Device: reusable respiratorsDentist wearing Full face reusable respirator+ Filter will examin the patient |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Six to ten-year-old patients
Key exclusion criteria (2 listed)
- emergency patients
- patients who have systemic, mental or psychological conditions as indicated by their medical history,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reusable respiratorsDentist wearing reusable respirator will examin the patient | Device | Face shield+ surgical mask, Full face reusable respirator+ Filter, Goggles + surgical mask, Half face reusable respirator+ Filter |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 36138354Azab 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reusable respirators in people with COVID-19 and Infections, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arabic version of children's fear survey schedule-dental subscale (CFSS-DS) (time frame: just after examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05371561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.