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Completed

NCT Number: NCT04914208

Effect of Wearing Face Masks on Salivary Parameters and Halitosis

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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Key information

Conditions

Dry Mouth Halitosis Mouth Diseases Pathological Conditions, Signs and Symptoms Salivary Gland Diseases Signs and Symptoms Signs and Symptoms, Digestive Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Göttingen, Lower Saxony, 37075, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Determination of unstimulated saliva flow rate

    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.

    mL/min

Secondary outcomes

  1. Determination of stimulated saliva flow rate

    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.

    mL/min

  2. Determination of unstimulated and stimulated saliva 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.

    pH

  3. Determination of unstimulated and stimulated salivary buffer capacity

    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.

    pH

  4. Determination of volatile sulphur compounds (VSC)

    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.

    ppm

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Registry information

Official study title

Effect of Wearing Face Masks on Oral Health

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2021
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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