Effect of Wearing Face Masks on Salivary Parameters and Halitosis

• Register: ClinicalTrials.gov
• Last refreshed on: 14 June 2021
• Main ID: NCT04914208
• Date of registration: 30/05/2021
• Prospective Registration: Yes
• Primary sponsor: University of Göttingen
• Public title: Effect of Wearing Face Masks on Salivary Parameters and Halitosis
• Scientific title: Effect of Wearing Face Masks on Oral Health
• Date of first enrolment: July 1, 2021
• Target sample size: 40
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT04914208
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Annette Wiegand, Prof. Dr. med. dent.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dry Mouth

Halitosis

Intervention(s)

Device: DIY face mask

Device: FFP2 respirator mask

Device: Surgical face mask

Other: Use of fluoridated toothpaste

Other: Waiting for 4 hours without wearing a mask

Primary Outcome(s)

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.]

Secondary Outcome(s)

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.]

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.]

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.]

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.]

Secondary ID(s)

2021-01521

30/2/21

FaceMasks-Halitosis

Source(s) of Monetary Support

Please refer to primary and secondary sponsors