CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
Distilled Water +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04721457
NCT04721457Phase 4Completed

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

King Abdulaziz University·interventional·Posted Jan 22, 2021·Updated Jul 21, 2022

In Brief

A Phase 4 clinical trial evaluating Distilled Water, 1% Povidone Iodine (PVP-I), and 4 other interventions for SARS-CoV-2 and 7 related conditions. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSaudi Arabia
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJan 22, 2021
Enrollment StartJan 3, 2021
Primary CompletionMar 28, 2021
Study CompletionDec 10, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.4 years ago

Interventions

Distilled Waterdrug

Control group

1% Povidone Iodine (PVP-I)drug

Over-the-counter antiseptic mouth rinse

1.5% Hydrogen Peroxide (H2O2)drug

Over-the-counter antiseptic mouth rinse

0.075% Cetylpyridinium Chloride (CPC)drug

Over-the-counter antiseptic mouth rinse

0.1% Sodium Hypochloritedrug

Over-the-counter antiseptic mouth rinse

No rinse groupother

second control group