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

July 18, 2022 updated by: MANAR ALZAHRANI, King Abdulaziz University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • Alhamra TETAMMAN clinic (PHC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Distilled Water
Vigorously rinse with 15 ml of the distilled water for 30 s (Water for Injections BP; Pharmaceutical Solutions Industry, Jeddah, SA)
Drug: Distilled Water
Control group
Other Names:
  • water (Water for Injections BP; Pharmaceutical Solutions Industry, Jeddah, SA)
Active Comparator: Povidone Iodine (PVP-I)
Vigorously rinse with 15 ml of the 1% povidone-iodine (PVP-I) (Betadine Mouthwash/Gargle; Avrio Health LP, Stamford, CT, USA) for 30 s
Drug: 1% Povidone Iodine (PVP-I)
Over-the-counter antiseptic mouth rinse
Other Names:
  • Betadine Mouthwash/Gargle; Avrio Health LP, Stamford, CT, USA
Active Comparator: Hydrogen Peroxide (H2O2)
Vigorously rinse with 15 ml of the 1.5% hydrogen peroxide (H2O2) (Peroxyl; Colgate-Palmolive, Guildford, UK) for 30 s
Drug: 1.5% Hydrogen Peroxide (H2O2)
Over-the-counter antiseptic mouth rinse
Other Names:
  • Peroxyl; Colgate-Palmolive, Guildford, UK
Active Comparator: Cetylpyridinium Chloride (CPC)
Vigorously rinse with 15 ml of the 0.075% cetylpyridinium chloride (CPC) (Colgate Total; Colgate-Palmolive, Guildford, UK) for 30 s
Drug: 0.075% Cetylpyridinium Chloride (CPC)
Over-the-counter antiseptic mouth rinse
Other Names:
  • Colgate Total; Colgate-Palmolive, Guildford, UK
Active Comparator: Sodium Hypochlorite
Vigorously rinse with 15 ml of the 80 ppm sodium hypochlorite (NaOCl) (Clinisept Dental Mouthwash; Clinical Health Technologies, Hinckley, Leicestershire, UK) for 30 s
Drug: 0.1% Sodium Hypochlorite
Over-the-counter antiseptic mouth rinse
Other Names:
  • Clinisept Dental Mouthwash; Clinical Health Technologies, Hinckley, Leicestershire, UK
Placebo Comparator: No rinse group
There is no mouth rinse in this group. Patients will collect the saliva at all 4-time points without gargling with the mouth rinse.
Other: No rinse group
second control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (T0) vs 5 minutes (T1), baseline (T0) vs 30 minutes (T2), and baseline (T0) vs 60 minutes T3)
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
Compare Baseline (T0)
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
5 minutes post rinsing (T1)
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
30 minutes post rinsing (T2)
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
60 minutes post rinsing (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Investigators

  • Principal Investigator: MANAR M ALZAHRANI, MSD, FRCD(C), King Abdulaziz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2021

Primary Completion (Actual)

March 28, 2021

Study Completion (Actual)

December 10, 2021

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-02-J-002; 1384

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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