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Effect of Wearing Face Masks on Salivary Parameters and Halitosis

Primary Purpose

Dry Mouth, Halitosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
DIY face mask
Surgical face mask
FFP2 respirator mask
Waiting for 4 hours without wearing a mask
Use of fluoridated toothpaste
Sponsored by
University of Göttingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dry Mouth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Wearing a face mask for 4 hours

4 hours without wearing a face mask

Arm Description

Participants are wearing different kinds of face masks for 4 hours each. Masks are worn on different days and the order is randomly assigned.

Participants do not wear any face mask for 4 hours.

Outcomes

Primary Outcome Measures

Determination of unstimulated saliva flow rate
mL/min

Secondary Outcome Measures

Determination of stimulated saliva flow rate
mL/min
Determination of unstimulated and stimulated saliva pH
pH
Determination of unstimulated and stimulated salivary buffer capacity
pH
Determination of volatile sulphur compounds (VSC)
ppm

Full Information

First Posted
May 30, 2021
Last Updated
December 2, 2022
Sponsor
University of Göttingen
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1. Study Identification

Unique Protocol Identification Number
NCT04914208
Brief Title
Effect of Wearing Face Masks on Salivary Parameters and Halitosis
Official Title
Effect of Wearing Face Masks on Oral Health
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
April 8, 2022 (Actual)
Study Completion Date
April 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Göttingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Mouth, Halitosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wearing a face mask for 4 hours
Arm Type
Active Comparator
Arm Description
Participants are wearing different kinds of face masks for 4 hours each. Masks are worn on different days and the order is randomly assigned.
Arm Title
4 hours without wearing a face mask
Arm Type
Other
Arm Description
Participants do not wear any face mask for 4 hours.
Intervention Type
Device
Intervention Name(s)
DIY face mask
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Surgical face mask
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
FFP2 respirator mask
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waiting for 4 hours without wearing a mask
Intervention Description
Participants do not wear any face mask for 4 hours (beginning between 8 and 9 a.m.).
Intervention Type
Other
Intervention Name(s)
Use of fluoridated toothpaste
Intervention Description
Participants use fluoridated toothpaste.
Primary Outcome Measure Information:
Title
Determination of unstimulated saliva flow rate
Description
mL/min
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.
Secondary Outcome Measure Information:
Title
Determination of stimulated saliva flow rate
Description
mL/min
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.
Title
Determination of unstimulated and stimulated saliva pH
Description
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.
Title
Determination of unstimulated and stimulated salivary buffer capacity
Description
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.
Title
Determination of volatile sulphur compounds (VSC)
Description
ppm
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology
City
Göttingen
State/Province
Lower Saxony
ZIP/Postal Code
37075
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32824564
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.
Results Reference
background
PubMed Identifier
23768438
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.
Results Reference
background
PubMed Identifier
22168256
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.
Results Reference
background
PubMed Identifier
36459058
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.
Results Reference
result

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Effect of Wearing Face Masks on Salivary Parameters and Halitosis

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