Effect of Wearing Face Masks on Salivary Parameters and Halitosis

NCT04914208 | Completed

• 3 other identifiers: FaceMasks-Halitosis30/2/212021-01521
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Dry Mouth; Halitosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Determination of stimulated saliva flow rate

  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

  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

  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)

  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.

Study Arms (2)

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.

Device: DIY face mask; Device: Surgical face mask; Device: FFP2 respirator mask; Other: Use of fluoridated toothpaste

4 hours without wearing a face mask

OTHER

Participants do not wear any face mask for 4 hours.

Other: Waiting for 4 hours without wearing a mask; Other: Use of fluoridated toothpaste

Interventions

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.

Wearing a face mask for 4 hours

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.

Wearing a face mask for 4 hours

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.

Wearing a face mask for 4 hours

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.).

4 hours without wearing a face mask

Use of fluoridated toothpaste OTHER

Participants use fluoridated toothpaste.

4 hours without wearing a face mask; Wearing a face mask for 4 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Oral healthy adult volunteers who are able to give written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Göttingen: lead

Study Sites (1)

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

Göttingen, Lower Saxony, 37075, Germany

Location

Related 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.

  PMID: 32824564 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.

  PMID: 23768438 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.

  PMID: 22168256 BACKGROUND

• 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.

  PMID: 36459058 RESULT

MeSH Terms

Conditions

Xerostomia; Halitosis

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Dental Practitioner

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 4, 2021
• Study Start: September 28, 2021
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

DE (1)