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Completed

NCT Number: NCT04721457

The Efficacy of Pre-procedural Mouth Rinses on COVID-19 Saliva Viral Load

Preoperative antiseptic mouth rinses have been widely used as a standard protocol before routine dental treatment reduces oral microorganism counts. During dental procedures, aerosolized microorganisms contaminate the dental environment and nearby surfaces and remain suspended for 4 hours. Thus, the reduction in the number of aerosolized microorganisms by pre-procedural rinsing may reduce cross-contamination between dentists, office personnel, and patients. Recent reviews have advocated the use of preoperative rinsing to control and reduce the risk of SARS-CoV-2 transmission. However, no clinical studies have been done yet to support the effectiveness of any pre-procedural oral rinses against SARS-CoV-2. The proposed study will mitigate the spread of COVID-19 disease in dental healthcare facilities and ensure the patients' good health and healthcare workers. The purpose of this clinical trial is to compare the efficacy of four commercially available mouth rinses povidone-iodine (PVP-I), hydrogen peroxide (H2O2), cetylpyridinium chloride (CPC), sodium hypochlorite (NaOCl) on the salivary SARS-CoV-2 viral load at four-time points (baseline and 5-, 30-, and 60-min post rinsing) relative to two control groups (distilled water and no-rinse) in a cohort of positive COVID-19 patients.

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Key information

Conditions

SARS-CoV-2 COVID-19 Coronaviridae Infections Coronavirus Coronavirus Infections Covid19 Infections Lung Diseases Mouthwashes Nidovirales Infections Pneumonia Pneumonia, Viral Polymerase Chain Reaction RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Saliva Viral Load Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alhamra TETAMMAN clinic (PHC)

Jeddah, Saudi Arabia

About this study

Saliva specimens will be collected from COVID-19-positive patients presenting to TETAMMAN clinics from January to March 2021. The total number of participants in this study will be 90 participants, with 15 per group (6 groups), and 4 saliva specimens from each patient in each group. A total of four mouth rinses and two control groups (distilled water and no-rinse). The studied mouth rinses were: 1% povidone-iodine (PVP-I) (Betadine Mouthwash/Gargle; Avrio Health LP, Stamford, CT, USA), 1.5% hydrogen peroxide (H2O2) (Peroxyl; Colgate-Palmolive, Guildford, UK), 0.075% cetylpyridinium chloride (CPC) (Colgate Total; Colgate-Palmolive, Guildford, UK), 80 ppm sodium hypochlorite (NaOCl) (Clinisept Dental Mouthwash; Clinical Health Technologies, Hinckley, Leicestershire, UK). Confirmed positive cases of COVID-19 will be recruited randomly at each TETAMMAN clinic based on inclusion and exclusion criteria to satisfy the total of 90 patients. Each participant will be introduced briefly to the study aims and then asked to sign a consent form. Demographic data and medical history will then be collected for each participant. The participants will be blinded to all mouth rinses, which will be labeled with identification codes, and presented in similar packages. Unstimulated saliva will be collected using the passive drool technique. Four saliva samples for each patient will be collected. The first saliva sample will be considered as a baseline sample that represents the baseline viral load. Then patients will be instructed to gargle the assigned mouth rinse gently, for 15 seconds. After that, the participants will spit the mouthwashes into a disposable plastic cup. After that, different salivary samples will be collected at 5 minutes, 30 minutes, and then 60 minutes. Thus, a total of four saliva samples will be gathered from each patient. The viral load will be measured by quantitative reverse transcription PCR.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults age 18 years or older presented to TETAMMAN clinics, Jeddah, Saudi Arabia.
  • COVID-19-positive patients confirmed by RT-PCR and within two days of oral or nasopharyngeal swabs
  • Asymptomatic or within seven days of the onset of symptoms.
  • Has the ability to rinse and expectorate.

Exclusion criteria

  • Participants who established antiviral, corticosteroid, antimicrobial, or immunosuppressive medications.
  • Known allergy to one of the constituents of the mouth rinse
  • Thyroid disease or on current radioactive iodine treatment
  • Pregnant or breastfeeding women
  • Lithium therapy
  • History of radiotherapy or chemotherapy
  • Use of mouthwash before presented to TETAMMAN clinics

Treatment and study plan

distilled water

Drug

Control group

Other names: water (Water for Injections BP; Pharmaceutical Solutions Industry, Jeddah, SA)

1% Povidone Iodine (PVP-I)

Drug

Over-the-counter antiseptic mouth rinse

Other names: Betadine Mouthwash/Gargle; Avrio Health LP, Stamford, CT, USA

1.5% Hydrogen Peroxide (H2O2)

Drug

Over-the-counter antiseptic mouth rinse

Other names: Peroxyl; Colgate-Palmolive, Guildford, UK

0.075% Cetylpyridinium Chloride (CPC)

Drug

Over-the-counter antiseptic mouth rinse

Other names: Colgate Total; Colgate-Palmolive, Guildford, UK

0.1% Sodium Hypochlorite

Drug

Over-the-counter antiseptic mouth rinse

Other names: Clinisept Dental Mouthwash; Clinical Health Technologies, Hinckley, Leicestershire, UK

No rinse group

Other

second control group

Primary outcomes

  1. Change in the salivary viral load within each mouth rinse groups and controls

    Time frame: Baseline (T0) vs 5 minutes (T1), baseline (T0) vs 30 minutes (T2), and baseline (T0) vs 60 minutes T3)

    change in the salivary viral load overtime within each group will be measured by quantitative reverse transcription PCR (RT-qPCR) and expressed as copies/ml

  2. Compare salivary viral load between mouth rinse groups and controls at baseline

    Time frame: Compare Baseline (T0)

    Difference in Salivary viral load baseline value between the groups

  3. Compare salivary viral load between mouth rinse groups and controls at 5 minutes post rinsing

    Time frame: 5 minutes post rinsing (T1)

    Difference in Salivary viral load baseline value between the groups

  4. Compare salivary viral load between mouth rinse groups and controls at 30 minutes post rinsing

    Time frame: 30 minutes post rinsing (T2)

    Difference in Salivary viral load baseline value between the groups

  5. Compare salivary viral load between mouth rinse groups and controls at 60 minutes post rinsing

    Time frame: 60 minutes post rinsing (T3)

    Difference in Salivary viral load baseline value between the groups

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

Mouth Rinses Efficacy on Salivary SARS-CoV-2 Viral Load: A Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2021
Registry last updated
Jul 21, 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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