COVID-19
Conditions
Keywords
Mouth Wash, Viral Load
Brief summary
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 .
Detailed description
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.
Interventions
DRUGChlorhexidine digluconate, povidone iodine
This is a mouth wash that can be used over the counter.
Sponsors
King Abdulaziz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| E Genes | 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
| Measure | Time frame | Description |
|---|---|---|
| S Genes | 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. |
Countries
Saudi Arabia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chlorhexidine Digluconate Mouthwash This is a mouth wash that can be used over the counter. | 15 |
| Chlorhexidine Digluconate Lozenges This is a mouth wash that can be used over the counter. | 15 |
| Povidone Iodine Mouthwash This is a mouth wash that can be used over the counter. | 15 |
| Tap Water It is regular tap water | 15 |
| Total | 60 |
Baseline characteristics
| Characteristic | Chlorhexidine Digluconate Lozenges | Total | Chlorhexidine Digluconate Mouthwash | Tap Water | Povidone Iodine Mouthwash |
|---|---|---|---|---|---|
| Age, Continuous | 36.20 Year STANDARD_DEVIATION 13.21 | 37.40 Year STANDARD_DEVIATION 13.21 | 37.80 Year STANDARD_DEVIATION 11.24 | 41.73 Year STANDARD_DEVIATION 17.14 | 33.86 Year STANDARD_DEVIATION 10.29 |
| E genes | 26.14 Cycle STANDARD_DEVIATION 5.98 | 26.44 Cycle STANDARD_DEVIATION 6.01 | 26.23 Cycle STANDARD_DEVIATION 7.37 | 27.59 Cycle STANDARD_DEVIATION 5.01 | 25.85 Cycle STANDARD_DEVIATION 6.33 |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — | — |
| Sex: Female, Male Female | 3 Participants | 18 Participants | 7 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 12 Participants | 42 Participants | 8 Participants | 11 Participants | 11 Participants |
| S genes | 24.83 Cycle STANDARD_DEVIATION 5.13 | 25.24 Cycle STANDARD_DEVIATION 5.53 | 25.03 Cycle STANDARD_DEVIATION 6.63 | 26.11 Cycle STANDARD_DEVIATION 4.04 | 25.18 Cycle STANDARD_DEVIATION 6.35 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
E Genes
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorhexidine Digluconate Mouthwash | E Genes | 28.50 Cycle | Standard Deviation 5.21 |
| Chlorhexidine Digluconate Lozenges | E Genes | 27.33 Cycle | Standard Deviation 4.9 |
| Povidone Iodine Mouthwash | E Genes | 30.28 Cycle | Standard Deviation 6.33 |
| Tap Water | E Genes | 27.80 Cycle | Standard Deviation 4.33 |
Secondary
S Genes
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorhexidine Digluconate Mouthwash | S Genes | 27.86 Cycle | Standard Deviation 5.89 |
| Chlorhexidine Digluconate Lozenges | S Genes | 26.74 Cycle | Standard Deviation 5.27 |
| Povidone Iodine Mouthwash | S Genes | 28.09 Cycle | Standard Deviation 6.37 |
| Tap Water | S Genes | 27.87 Cycle | Standard Deviation 3.83 |