NCT05188651

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

January 30, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

January 10, 2022

Last Update Submit

March 17, 2026

Conditions

HypoxiaHypercapniaCOVID-19 Pandemic

Outcome Measures

Primary Outcomes (1)

  • change in peripheral oxygen saturation using FFP2/N95 masks

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

Study Arms (2)

dental professionals wearing FFP2/N95 masks

Behavioral: face masks

dental professionals wearing type IIR fluid resistant surgical masks

Behavioral: face masks

Interventions

face masksBEHAVIORAL

wearing face masks

dental professionals wearing FFP2/N95 masksdental professionals wearing type IIR fluid resistant surgical masks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all kind of dental professionals

You may qualify if:

  • dental professionals

You may not qualify if:

  • subjects not signing informed consent
  • subjects unable to wear facemasks due to underlying conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Universitario A. Gemelli

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

HypoxiaHypercapniaCOVID-19

Interventions

Masks

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student, Institute of dental clinic and maxillofacial surgery

Study Record Dates

First Submitted

January 10, 2022

First Posted

January 12, 2022

Study Start

January 30, 2022

Primary Completion

April 1, 2022

Study Completion

September 1, 2022

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

IT(1)