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

Summary

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.

Conditions

• SARS-CoV-2
• COVID-19
• Mouthwashes
• Viral Load
• Polymerase Chain Reaction
• Coronavirus
• Covid19
• Saliva

Interventions

DRUG

Distilled Water

Control group

DRUG

1% Povidone Iodine (PVP-I)

Over-the-counter antiseptic mouth rinse

DRUG

1.5% Hydrogen Peroxide (H2O2)

Over-the-counter antiseptic mouth rinse

DRUG

0.075% Cetylpyridinium Chloride (CPC)

Over-the-counter antiseptic mouth rinse

DRUG

0.1% Sodium Hypochlorite

Over-the-counter antiseptic mouth rinse

OTHER

No rinse group

second control group

Sponsors & Collaborators

• King Abdulaziz University

  lead OTHER

Principal Investigators

• MANAR M ALZAHRANI, MSD, FRCD(C) · King Abdulaziz University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-03

Primary Completion

2021-03-28

Completion

2021-12-10

FDA Drug

Yes

Countries

• Saudi Arabia

Study Locations