Effect of Wearing Face Masks on Salivary Parameters and Halitosis

Effect of Wearing Face Masks on Oral Health

During the current COVID-19 pandemic, the use of face masks is recommended / mandatory to prevent infection. Patients and students have reported to experience limitations in their oral health-related quality of life, especially with regard to the occurrence of dry mouth and halitosis, while wearing face masks.

Scientific studies regarding the effects of face masks have so far focused exclusively on medical staff. Studies among the general population are not yet available, but are of interest as dry mouth is a risk factor for dental diseases (e.g., caries, erosion).

Therefore, the present study aims at measuring the effect of wearing different face masks on salivary parameters (unstimulated and stimulated saliva flow rate, pH, buffer capacity) and halitosis (volatile sulphur compounds).

Study Overview

• Status: Completed
• Conditions: Halitosis; Dry Mouth
• Intervention / Treatment: Device: DIY face mask; Device: Surgical face mask; Device: FFP2 respirator mask; Other: Use of fluoridated toothpaste; Other: Waiting for 4 hours without wearing a mask

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Göttingen, Lower Saxony, Germany, 37075
      • University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Oral healthy adult volunteers who are able to give written consent

Exclusion Criteria:

• Non-fulfillment of the inclusion criteria
• Denied access to the University Medical Center Goettingen at the Corona screening
• Exemption from wearing a face mask for medical reasons
• Medical reasons hindering participants from refraining eating and drinking prior (except for water) or during the visits
• Hyposalivation / xerostomia (unstimulated saliva < 0.3 mL/min, stimulated saliva < 0.7 mL/min)
• Refusal to use fluoridated toothpastes
• Smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Wearing a face mask for 4 hours; Participants are wearing different kinds of face masks for 4 hours each. Masks are worn on different days and the order is randomly assigned.	Device: DIY face mask; Participants are wearing a DIY face mask for 4 hours (beginning between 8 and 9 a.m.). The correct fit of the face mask is checked by the study officials and corrected if necessary.; Device: Surgical face mask; Participants are wearing a surgical face mask for 4 hours (beginning between 8 and 9 a.m.). The correct fit of the face mask is checked by the study officials and corrected if necessary.; Device: FFP2 respirator mask; Participants are wearing a FFP2 respirator mask for 4 hours (beginning between 8 and 9 a.m.). The correct fit of the face mask is checked by the study officials and corrected if necessary.; Other: Use of fluoridated toothpaste; Participants use fluoridated toothpaste.
Other: 4 hours without wearing a face mask; Participants do not wear any face mask for 4 hours.	Other: Use of fluoridated toothpaste; Participants use fluoridated toothpaste.; Other: Waiting for 4 hours without wearing a mask; Participants do not wear any face mask for 4 hours (beginning between 8 and 9 a.m.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of unstimulated saliva flow rate	mL/min	Each day, prior (between 8 and 9 a.m.) and after wearing a face mask for 4 hours or 4 hours without wearing any mask. Saliva samples are collected for 5 min each.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of stimulated saliva flow rate	mL/min	Each day, prior (between 8 and 9 a.m.) and after wearing a face mask for 4 hours or 4 hours without wearing any mask. Stimulated saliva samples are collected for 5 min while chewing a paraffin pellet.
Determination of unstimulated and stimulated saliva pH	pH	Each day, prior (between 8 and 9 a.m.) and after wearing a face mask for 4 hours or 4 hours without wearing any mask. Saliva samples are collected for 5 min each. Stimulated saliva samples are collected while chewing a paraffin pellet.
Determination of unstimulated and stimulated salivary buffer capacity	pH	Each day, prior (between 8 and 9 a.m.) and after wearing a face mask for 4 hours or 4 hours without wearing any mask. Saliva samples are collected for 5 min each. Stimulated saliva samples are collected while chewing a paraffin pellet.
Determination of volatile sulphur compounds (VSC)	ppm	Each day, prior (between 8 and 9 a.m.) and after wearing a face mask for 4 hours or 4 hours without wearing any mask.

Collaborators and Investigators

• Sponsor: University of Göttingen

Publications and helpful links

General Publications

• Farronato M, Boccalari E, Del Rosso E, Lanteri V, Mulder R, Maspero C. A Scoping Review of Respirator Literature and a Survey among Dental Professionals. Int J Environ Res Public Health. 2020 Aug 17;17(16):5968. doi: 10.3390/ijerph17165968.
• Rebmann T, Carrico R, Wang J. Physiologic and other effects and compliance with long-term respirator use among medical intensive care unit nurses. Am J Infect Control. 2013 Dec;41(12):1218-23. doi: 10.1016/j.ajic.2013.02.017. Epub 2013 Jun 12.
• Shenal BV, Radonovich LJ Jr, Cheng J, Hodgson M, Bender BS. Discomfort and exertion associated with prolonged wear of respiratory protection in a health care setting. J Occup Environ Hyg. 2012;9(1):59-64. doi: 10.1080/15459624.2012.635133.
• Kanzow P, Rammert LS, Rohland B, Barke S, Placzek M, Wiegand A. Effect of face masks on salivary parameters and halitosis: Randomized controlled crossover trial. J Oral Pathol Med. 2023 Jan;52(1):56-62. doi: 10.1111/jop.13390. Epub 2022 Dec 13.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Actual): April 8, 2022
• Study Completion (Actual): April 8, 2022

Study Registration Dates

• First Submitted: May 30, 2021
• First Submitted That Met QC Criteria: May 30, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Halitosis
• Other Study ID Numbers: FaceMasks-Halitosis; 30/2/21 (Other Identifier: Local Ethics Commission); 2021-01521 (Other Identifier: UMG study center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No