Effect of Wearing Face Masks on Salivary Parameters and Halitosis

Not Applicable

Completed

• Conditions: Dry Mouth; Halitosis
• Interventions: Other: Waiting for 4 hours without wearing a mask; Device: DIY face mask; Other: Use of fluoridated toothpaste; Device: Surgical face mask; Device: FFP2 respirator mask

• Registration Number: NCT04914208
• Lead Sponsor: University of Göttingen

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-30
• Study First Submitted QC: 2021-05-30
• Study First Posted: 2021-06-04
• Study Start: 2021-09-28
• Primary Completion: 2022-04-08
• Study Completion: 2022-04-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Wearing a face mask for 4 hours	FFP2 respirator mask	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	Waiting for 4 hours without wearing a mask	Participants do not wear any face mask for 4 hours.
4 hours without wearing a face mask	Use of fluoridated toothpaste	Participants do not wear any face mask for 4 hours.
Wearing a face mask for 4 hours	DIY face mask	Participants are wearing different kinds of face masks for 4 hours each. Masks are worn on different days and the order is randomly assigned.
Wearing a face mask for 4 hours	Surgical face mask	Participants are wearing different kinds of face masks for 4 hours each. Masks are worn on different days and the order is randomly assigned.
Wearing a face mask for 4 hours	Use of fluoridated toothpaste	Participants are wearing different kinds of face masks for 4 hours each. Masks are worn on different days and the order is randomly assigned.

Primary Outcome Measures

Name	Time	Method
Determination of unstimulated 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. Saliva samples are collected for 5 min each.	mL/min

Secondary Outcome Measures

Name	Time	Method
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.	mL/min
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.	pH
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.	pH
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.	ppm

Trial Locations

Locations (1)

University Medical Center Goettingen, Dept. of Preventive Dentistry, Periodontology and Cariology; 🇩🇪 Göttingen, Lower Saxony, Germany