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| ID | Type | Description | Link |
|---|---|---|---|
| 30/2/21 | Other Identifier | Local Ethics Commission | |
| 2021-01521 | Other Identifier | UMG study center |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearing a face mask for 4 hours | Active Comparator | Participants are wearing different kinds of face masks for 4 hours each. Masks are worn on different days and the order is randomly assigned. |
|
| 4 hours without wearing a face mask | Other | Participants do not wear any face mask for 4 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIY face mask | Device | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology | Göttingen | Lower Saxony | 37075 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32824564 | Background | 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. | |
| 23768438 | Background | 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. |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| D006209 | Halitosis |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012817 | Signs and Symptoms, Digestive |
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| Surgical face mask | Device | 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 | Device | 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. |
|
| Waiting for 4 hours without wearing a mask | Other | Participants do not wear any face mask for 4 hours (beginning between 8 and 9 a.m.). |
|
| Use of fluoridated toothpaste | Other | Participants use fluoridated toothpaste. |
|
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. |
| 22168256 | Background | 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. |
| 36459058 | Result | 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |