Clinical trial NCT04914208: Effect of Wearing Face Masks on Salivary Parameters and Halitosis
Official title: Effect of Wearing Face Masks on Oral Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Mouth
Halitosis
Lead sponsor: University of Göttingen
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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).


Eligibility 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

Primary outcomes:
measure: Determination of unstimulated saliva flow rate
timeFrame: 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 outcomes:
measure: Determination of stimulated saliva flow rate
timeFrame: 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.
measure: Determination of unstimulated and stimulated saliva pH
timeFrame: 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.
measure: Determination of unstimulated and stimulated salivary buffer capacity
timeFrame: 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.
measure: Determination of volatile sulphur compounds (VSC)
timeFrame: 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.
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology
state: Lower Saxony
Study officials:
References:
citation: 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.
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.
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.
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.