Effect of Wearing Face Masks on Salivary Parameters and Halitosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-28

Study Completion Date

2022-04-08

Brief Summary

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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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Detailed Description

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Conditions

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Dry Mouth Halitosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Wearing a face mask for 4 hours

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

Group Type ACTIVE_COMPARATOR

DIY face mask

Intervention Type 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.

Surgical face mask

Intervention Type 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

Intervention Type 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.

Use of fluoridated toothpaste

Intervention Type OTHER

Participants use fluoridated toothpaste.

4 hours without wearing a face mask

Participants do not wear any face mask for 4 hours.

Group Type OTHER

Waiting for 4 hours without wearing a mask

Intervention Type OTHER

Participants do not wear any face mask for 4 hours (beginning between 8 and 9 a.m.).

Use of fluoridated toothpaste

Intervention Type OTHER

Participants use fluoridated toothpaste.

Interventions

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DIY face mask

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

Surgical face mask

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

FFP2 respirator mask

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 DEVICE

Waiting for 4 hours without wearing a mask

Participants do not wear any face mask for 4 hours (beginning between 8 and 9 a.m.).

Intervention Type OTHER

Use of fluoridated toothpaste

Participants use fluoridated toothpaste.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes