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临床试验/NCT04914208
NCT04914208已完成不适用

Effect of Wearing Face Masks on Oral Health

University of Göttingen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年9月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Determination of unstimulated saliva flow rate

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Determination of unstimulated saliva flow rate

时间窗: 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

次要结局

  • 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.)

研究者

发起方
University of Göttingen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic.

Senior Dental Practitioner

University Medical Center Goettingen

研究点 (2)

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