ClinicalTrials.gg
CompletedNCT05188651Updated Mar 18, 2026

Effect of FFP2 Masks on Peripheral Oxygen Saturation and Pulse Rate During the COVID-19 Pandemic

An observational study in Hypoxia, Hypercapnia and COVID-19 Pandemic, sponsored by Catholic University of the Sacred Heart. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Catholic University of the Sacred Heart · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

aim of this research is to evaluate the effects of FFP2/N95 masks on peripheral oxygen saturation and pulse rate in dental professionals

02

Conditions studied

  • Hypoxia
  • Hypercapnia
  • COVID-19 Pandemic
03

In context

Hypoxia

1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.

This study's enrollment of 60 is below the median of 79 across 277 observational studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Catholic University of the Sacred Heart is the lead sponsor of 237 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

all kind of dental professionals

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • dental professionals

Exclusion criteria

Exclusion Criteria:

  • subjects not signing
  • subjects unable to wear facemasks due to underlying conditions
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • dental professionals wearing FFP2/N95 masks

    Behavioral: face masks

  • dental professionals wearing type IIR fluid resistant surgical masks

    Behavioral: face masks

Interventions

  • Behavioralface masks

    wearing face masks

06

What researchers measure

Primary outcomes

  1. change in peripheral oxygen saturation using FFP2/N95 masks

    Time frame: before wearing face mask, after 30 minutes, after 1 hour, at the end of the clinical activity after 4-5 hours

07

Study locations

1 site
  • Policlinico Universitario A. Gemelli
    Roma, RM 00168, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2022 to primary completion in Apr 2022, 2 months.

Of 125 non-industry observational studies under Hypoxia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 74. This study's 2 months is below that.

Counting every sponsor, half of 155 studies reached it within 14 months; a quarter within 3 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2022
First posted
Jan 12, 2022
StartActual
Jan 30, 2022
Primary completionActual
Apr 1, 2022
CompletionActual
Sep 1, 2022
Last update
Mar 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05188651
Responsible party
Anna Alessandri Bonetti (PhD student, Institute of dental clinic and maxillofacial surgery, Catholic University of the Sacred Heart) — Principal investigator
First posted
Jan 12, 2022
Start date
Jan 30, 2022
Primary completion
Apr 1, 2022
Completion
Sep 1, 2022
Last update
Mar 18, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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