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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Ataturk 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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