Trial document




drksid header

  DRKS00023725

Trial Description

start of 1:1-Block title

Title

Clinical investigation of the effectiveness of different mouth rinses in Covid-19-Patients

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://-

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

It is important that such studies are conducted in order to compare the effectiveness of mouth rinses and make appropriate recommendations to the consumer. All mouth rinses tested in this study are commercially available or pharmacy-prepared products that are currently used in dental offices. The use of the rinsing solutions is intended to reduce covid virus.
The data on this subject is not clear, so different solutions are used for rinsing.
Three mouth rinsing solutions (hydrogen peroxide, chlorhexidine and Listerine) with different concentrations are studied. Hydrogen peroxide and chlorhexidine have been used for years in various treatments to reduce bacteria. For current reasons, the scientific interest, the reduction of viruses in the oral cavity, is aroused.
In this clinical trial, 4 different mouth rinses will be compared. In case of participation, one of the three mouth rinses will be used once. Study participants will be recruited with the support of the health department.
The Primary Hypothesis states that after the application of mouth rinses containing hydrogen peroxide, chlorhexidine and Listerine, a reduction in SARS CoV 2 is observed immediately after, after 5 minutes, after 2 hours and after 5 hours.
According to the secondary hypothesis higher reductions in SARS CoV 2, compared to chlorhexidine, are observed after the use of the hydrogen-containing mouth rinses and Listerine.
The tertiary hypothesis states that the effectiveness of the hydrogen-containing mouth rinses is dependent on concentration and residence time.
According to the Quaternary hypothesis, the determination of coronavirus SAR-Co V-2 in the saliva-NaCl mixture, correlates with the throat swab.
The objectives of this study are to determine the virus detection in the pharynx of SARS-CoV-2 patients, after the application of the four different mouthwashes with different concentrations and residence time in the mouth, by laboratory evaluation. The second objective is to find out a correlation of the viral load, between the saliva-saline mixture and the throat swab.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Virus load reduction caused by mouth rinses

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

What specific data is shared?
Individual, anonymized results on which the article is based.

What other documents will be available?
Study protocol.

When will the data be available?
Immediately after publication, no end date.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00023725
  •   2021/01/04
  •   [---]*
  •   yes
  •   Approved
  •   214/2020, Ethik-Kommission der Universität Witten/Herdecke
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   COVID-19
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Single application of hydrogen peroxide (H2o2) 1% (10ml for 30s)
  •   Single application of a total of 15 ml of chlorhexidine (CHX 0.05%) and cetylpiridinium chloride (CPC 0.05%) for 30 s
  •   Single use of 20 ml Listerine Mild for 60s
  •   Single application of hydrogen peroxide (H2o2) 1,5% (30ml for 60s)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The aim of this study is to determine the virus detection in the throat, using polymerase chain reaction (PCR), in SARS-CoV-2 patients after using the four different mouthwashes with different concentrations and residence time in the mouth.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

The second goal is to find out a correlation of the viral load, between the saliva-NaCl mixture (rinsing with NaCl) and the throat swab.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2021/01/18
  •   60
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Age: 18-80 years
- Positive, confirmed disease with Covid-19
- Good general condition of the patient
- No elevated temperature
- No elevated blood pressure/pulse
- No increased respiratory rate
- No medication intake
- Presentation of the consent form of the Subject

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- severe general illness
- Subjects with physical and/or mental disabilities mental disabilities with limited manual and cognitive abilities and therefore no comparability possible
- Allergic reactions to the substances used in the study (e.g. hydrogen peroxide)
- alcohol abuse
- Lack of compliance, so that it cannot be ensured that the patients* comply with the study protocol.
- Pregnancy and lactation

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität Witten/Herdecke Fakultät für Gesundheit (Department für Zahn-, Mund- und Kieferheilkunde)Lehrstuhl für Zahnerhaltung und Präventive Zahnmedizin
    • Ms.  Prof. Dr. med. dent.  Mozhgan  Bizhang 
    • Alfred-Herrhausen-Straße 44
    • 58455  Witten
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universität Witten/Herdecke Fakultät für Gesundheit (Department für Zahn-, Mund- und Kieferheilkunde)Lehrstuhl für Zahnerhaltung und Präventive Zahnmedizin
    • Ms.  Prof. Dr. med. dent.  Mozhgan  Bizhang 
    • Alfred-Herrhausen-Straße 44
    • 58455  Witten
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universität Witten/Herdecke Fakultät für Gesundheit (Department für Zahn-, Mund- und Kieferheilkunde)Lehrstuhl für Zahnerhaltung und Präventive Zahnmedizin
    • Mr.  cand. med. dent.  Peter  Hahn 
    • Oberdorf 12
    • 58452  Witten
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Dentaid
    • Besselstraße 2-4
    • 68219  Mannheim
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Fördergemeinschaft Zahnmedizin e.V. Witten/Herdecke
    • Alfred-Herrhausen Straße 50
    • 58448  Witten
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.