Effect of Wearing Face Masks on Salivary Parameters and Halitosis

Halitosis Clinical Trial

Official title:

Effect of Wearing Face Masks on Oral Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914208
• Other study ID #: FaceMasks-Halitosis
• Secondary ID: 30/2/212021-0152
• Status: Completed
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: April 8, 2022

Study information

• Verified date: February 2024
• Source: University of Göttingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Mouth
• Halitosis

Intervention

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.
• 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.
• 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:
• 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.).
• Use of fluoridated toothpaste
Participants use fluoridated toothpaste.

Locations

Country	Name	City	State
Germany	University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology	Göttingen	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Göttingen

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.