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NCT Number: NCT04941131

The Role of Chlorhexidine in Minimizing the Viral Load Among COVID-19 Patients

Existing evidence confirmed that saliva and oral cavity to be a reservoir for SARS-CoV-2. In dental clinic aerosol-producing-procedures pose a significant risk for transmission of the infection . It is very important to minimize the risk of transmission in dental office reducing the load of SARS-CoV-2 in saliva if possible, in suspect or conformed cases. Preprocedural mouth rises have been used widely to minimize the number of oral microorganisms. Multiple studies confirmed the efficacy of those mouth rinses in reducing the possibility of transmission of SARS-CoV-2 infection .

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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

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King Abdulaziz University , Faculty of Dentistry

Jeddah, Saudi Arabia

About this study

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is one of the coronaviruses such as (SARS & MERS) which are commonly known for causing severe respiratory illnesses. SARS-CoV-2 is considered to be the leading cause of coronavirus disease (COVID-19) . On March 11th 2020, the WHO announced that SARS-CoV-2 is a global pandemic. Based on COVID-19 Saudi Arabia Ministry of Health Dashboard, globally, as of April 5th 2021, there have been more than 131 million confirmed cases of the disease including more than 2 million deaths. Nationally, as of April 5th 2021, there have been 392,682 confirmed cases including 6,697 deaths .

The diagnosis of COVID-19 involves molecular testing which is the gold standard and the WHO most recommended method of diagnosis. SARS-CoV-2 seemed to be very contagious and the chances of its transmission even before any symptoms occur are very high. It has been documented that COVID-19 disease incubation period to range between 1-14 days, most reported to be between 3 to 7 days with some evidence suggested the incubation period of 5 days. Evidence concerned about the spread of infection due to missed screened cases especially when individuals are unaware of their infection status and didn't show any symptoms yet.

Existing evidence confirmed that saliva and oral cavity to be a reservoir for SARS-CoV-2 . Multiple studies suggested SARS-CoV-2 to be airborne infection, and get transmitted through aerosols. In dental clinic aerosol-producing-procedures pose a significant risk for transmission of the infection. It is very important to minimize the risk of transmission in dental office reducing the load of SARS-CoV-2 in saliva if possible, in suspect or conformed cases. Preprocedural mouth rises have been used widely to minimize the number of oral microorganisms. Multiple studies confirmed the efficacy of those mouth rinses in reducing the possibility of transmission of SARS-CoV-2 infection .

The aim of our study is to determine the efficacy of different mouthwash in reducing the SARS-CoV-2 viral load in saliva of COVID-19 confirmed cases compared with tap water.

The objectives of the study are to determine the viral load, assess the cases clinical information & disease manifestation, plus the cases demographic characteristics believed to have an influence on the disease characteristics.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A history of positive nasal swabs for SARS-CoV-2 based on reverse-transcription polymerase chain reaction (RT-PCR) assays.

Exclusion criteria

  • History of allergy to any of the products that will be used
  • known pregnancy
  • Renal failure

Treatment and study plan

Chlorhexidine digluconate, povidone iodine

Drug

This is a mouth wash that can be used over the counter.

Primary outcomes

  1. E Genes

    Time frame: 6 months

    Gene viral load serves as a proxy measure for the presence and quantity of SARS-CoV-2 virus in patient samples. Since the E gene is expressed early and reliably during viral replication, changes in its detected levels reflect the dynamics of viral presence. Quantified using RT-qPCR, with results expressed as cycle threshold (Ct) values-the number of amplification cycles required to detect the gene above background levels. Lower Ct values indicate higher viral loads.

Secondary outcomes

  1. S Genes

    Time frame: 6 months

    Gene viral load serves as a proxy measure for the presence and quantity of SARS-CoV-2 virus in patient samples. Since the S gene is expressed early and reliably during viral replication, changes in its detected levels reflect the dynamics of viral presence. Quantified using RT-qPCR, with results expressed as cycle threshold (Ct) values-the number of amplification cycles required to detect the gene above background levels. Lower Ct values indicate higher viral loads.

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

The Role of Chlorhexidine in Minimizing the Viral Load Among COVID-19 Patients: A Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2021
Registry last updated
Jun 12, 2025

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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