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Completed

NCT Number: NCT05214196

The Efficacy of Oral Antiseptics Against COVID-19

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Atatürk University Faculty of Dentistry

Erzurum, 25240, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypochlorous Acid 0.02% Soln,Top (Crystaline) (HClO)

Drug

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)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2022
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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