Effect of Wearing Face Masks on Salivary Parameters and Halitosis

• ClinicalTrials.gov Identifier: NCT04914208
• Recruitment Status: Completed
• First Posted: June 4, 2021
• Last Update Posted: December 7, 2022
• Sponsor: University of Göttingen
• Information provided by (Responsible Party): Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic., University Medical Center Goettingen

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Dry Mouth; Halitosis	Device: DIY face mask; Device: Surgical face mask; Device: FFP2 respirator mask; Other: Waiting for 4 hours without wearing a mask; Other: Use of fluoridated toothpaste	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Wearing Face Masks on Oral Health
• Actual Study Start Date: September 28, 2021
• Actual Primary Completion Date: April 8, 2022
• Actual Study Completion Date: April 8, 2022

Arms and Interventions

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.
4 hours without wearing a face mask; Participants do not wear any face mask for 4 hours.	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.).; Other: Use of fluoridated toothpaste; Participants use fluoridated toothpaste.

Outcome Measures

Primary Outcome Measures :

1. Determination of unstimulated saliva flow rate [ Time Frame: 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. ]
   mL/min

Secondary Outcome Measures :

1. Determination of stimulated saliva flow rate [ Time Frame: 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. ]
   mL/min
2. Determination of unstimulated and stimulated saliva pH [ Time Frame: 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. ]
   pH
3. Determination of unstimulated and stimulated salivary buffer capacity [ Time Frame: 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. ]
   pH
4. Determination of volatile sulphur compounds (VSC) [ Time Frame: 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. ]
   ppm

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Germany

University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology

Göttingen, Lower Saxony, Germany, 37075

Sponsors and Collaborators

University of Göttingen

More Information

Publications of Results:

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.

Other 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.

• Responsible Party: Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic., Senior Dental Practitioner, University Medical Center Goettingen
• ClinicalTrials.gov Identifier: NCT04914208
• Other Study ID Numbers: FaceMasks-Halitosis; 30/2/21 ( Other Identifier: Local Ethics Commission ); 2021-01521 ( Other Identifier: UMG study center )
• First Posted: June 4, 2021
• Last Update Posted: December 7, 2022
• Last Verified: December 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Halitosis; Signs and Symptoms, Digestive