The Efficacy of Oral Antiseptics Against COVID-19

January 28, 2022 updated by: Sema Nur Sevinc, Ataturk University

The Effectiveness of Oral Antiseptics on the Intraoral Viral Load of SARS-CoV-2

In a study conducted on 75 COVID-19 patients, the effect of SARS-CoV-2 on viral load was investigated as a result of the use of hypochlorous acid and povidone-iodine as an oral antiseptic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before and 30 minutes after rinsing with mouth antiseptics, the participants were asked to rinse the mouth and throat for 30 seconds with 0.9% isotonic saline. The sample was sputtered into a sterile plastic container. The participants were grouped according to the type of oral antiseptics used. The effectiveness of SARS-CoV-2 viral load was investigated by rinsing the mouth and throat for 30 seconds with 20 ml of hypochlorous acid, povidone-iodine, and isotonic saline. Viral load was analyzed by RT-PCR analysis. The results were evaluated by statistical analysis.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey, 25240
        • Atatürk University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Positive SARS-CoV-2 RT-PCR result,
  • Adult hospitalized patient,
  • The participants have the physical and psychological ability to follow the instructions in the study.

Exclusion Criteria:

  • Patients intubated and supported by a mechanical respirator,
  • Severe acute or chronic medical or psychiatric condition,
  • History of significant adverse effects following use of oral hygiene products such as toothpaste and mouth rinses,
  • Active uncontrolled thyroid disease,
  • Developmental/cognitive disability,
  • Pregnancy,
  • Undergoing radioactive iodine therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypochlorous acid group
The effect of 0.02% Hypochlorous acid solution on viral load was investigated by using 25 COVID-19 patients as an oral antiseptic for 30 seconds.
Drug: Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)
SARS-CoV-2 sample was obtained from COVID-19 patients by rinsing the mouth and throat with 5 ml of isotonic saline before and 30 minutes after rinsing. In the hypochlorous acid group, 20 ml of HClO was asked to be rinsed in the mouth and throat for 30 seconds in 25 participants. In the povidone-iodine group, 20 ml of PVP-I was asked to be rinsed in the mouth and throat for 30 seconds in 25 participants. In the saline group, 20 ml of saline was asked to be rinsed in the mouth and throat for 30 seconds in 25 participants.
Other Names:
  • Povidone-iodine 0.5% (Betadine) (PVP-I)
  • Isotonic saline 0.9% (Gifrer)
Active Comparator: Povidone-iodine group
The effect on viral load was investigated by using 0.5% Povidone-iodine solution as an oral antiseptic for 30 seconds in 25 COVID-19 patients.
Drug: Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)
SARS-CoV-2 sample was obtained from COVID-19 patients by rinsing the mouth and throat with 5 ml of isotonic saline before and 30 minutes after rinsing. In the hypochlorous acid group, 20 ml of HClO was asked to be rinsed in the mouth and throat for 30 seconds in 25 participants. In the povidone-iodine group, 20 ml of PVP-I was asked to be rinsed in the mouth and throat for 30 seconds in 25 participants. In the saline group, 20 ml of saline was asked to be rinsed in the mouth and throat for 30 seconds in 25 participants.
Other Names:
  • Povidone-iodine 0.5% (Betadine) (PVP-I)
  • Isotonic saline 0.9% (Gifrer)
Placebo Comparator: Saline group
The effect on viral load was investigated by using 0.9% isotonic saline solution as a placebo for 30 seconds in 25 COVID-19 patients.
Drug: Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)
SARS-CoV-2 sample was obtained from COVID-19 patients by rinsing the mouth and throat with 5 ml of isotonic saline before and 30 minutes after rinsing. In the hypochlorous acid group, 20 ml of HClO was asked to be rinsed in the mouth and throat for 30 seconds in 25 participants. In the povidone-iodine group, 20 ml of PVP-I was asked to be rinsed in the mouth and throat for 30 seconds in 25 participants. In the saline group, 20 ml of saline was asked to be rinsed in the mouth and throat for 30 seconds in 25 participants.
Other Names:
  • Povidone-iodine 0.5% (Betadine) (PVP-I)
  • Isotonic saline 0.9% (Gifrer)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RT-PCR analysis
Time Frame: two weeks
For the quantitative analysis of the amount of SARS-CoV-2 RNA in the obtained samples, the Real-time Reverse Transcyptase Polymerase Chain Reaction method was used.
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Principal Investigator: Alparslan Dilsiz, Prof., Atatürk University, Faculty of Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 7, 2021

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

January 25, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

February 11, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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