The Efficacy of Oral Antiseptics Against COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214196
• Other study ID #: MIC1
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2021
• Est. completion date: December 7, 2021

Study information

• Verified date: January 2022
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 7, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
Turkey	Atatürk University Faculty of Dentistry	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RT-PCR analysis	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