NCT04721457

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: King Abdulaziz University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-03
• Primary completion: 2021-03-28
• Completion: 2021-12-10
• First posted: 2021-01-22
• Last updated: 2022-07-21

Locations

1 site across 1 country: Saudi Arabia

Regulatory

• FDA-regulated drug study