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.
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.
Drug: Distilled Water
Control group
Other Name: water (Water for Injections BP; Pharmaceutical Solutions Industry, Jeddah, SA)
Drug: 1% Povidone Iodine (PVP-I)
Over-the-counter antiseptic mouth rinse
Other Name: Betadine Mouthwash/Gargle; Avrio Health LP, Stamford, CT, USA
Drug: 1.5% Hydrogen Peroxide (H2O2)
Over-the-counter antiseptic mouth rinse
Other Name: Peroxyl; Colgate-Palmolive, Guildford, UK
Drug: 0.075% Cetylpyridinium Chloride (CPC)
Over-the-counter antiseptic mouth rinse
Other Name: Colgate Total; Colgate-Palmolive, Guildford, UK
Drug: 0.1% Sodium Hypochlorite
Over-the-counter antiseptic mouth rinse
Other Name: Clinisept Dental Mouthwash; Clinical Health Technologies, Hinckley, Leicestershire, UK
Other: No rinse group
second control group
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
Alhamra TETAMMAN clinic (PHC)
Jeddah, Saudi Arabia
MANAR M ALZAHRANI, MSD, FRCD(C), Principal Investigator
King Abdulaziz University