Efficacy of mouth-rinses in reducing SARS CoV-2 viral load in the saliva of COVID-19 positive patients in Indonesia

ISRCTN	ISRCTN12721265
DOI	https://doi.org/10.1186/ISRCTN12721265
Secondary identifying numbers	2021

Submission date: 12/04/2021
Registration date: 30/04/2021
Last edited: 04/05/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The purpose of this study is to evaluate the efficacy of commonly used commercial mouth-rinses (Betadine Gargle and Mouthwash, Oxyfresh Pro Formula mouthwash, Pepsodent Active Defense mouthwash) to reduce SARS CoV-2 viral level in the saliva of COVID-19 positive patients. This study will provide evidence on the use of mouth rinses in reducing the viral load in the saliva of the COVID-19 patients and thereby help in reducing transmission of COVID-19.

Who can participate?
Subjects with laboratory-confirmed diagnosis of COVID-19 can participate in the study.

What does the study involve?
Subjects are randomised to receive either Betadine Gargle and Mouthwash, Oxyfresh Pro Formula mouthwash, Pepsodent Active Defense mouthwash or water (control group). They are asked to provide saliva samples by spitting method. Then, subjects are asked to rinse their mouth with mouth-rinse or water. The saliva sample is collected again at 5 min, 3 h and 6 h post-application of mouth-rinse.

What are the possible benefits and risks of participating?
There is no known benefit to the subject from participation in this study. However, their participation may add to the medical knowledge about the efficacy of mouthwashes against SARS-CoV 2, as well as the use of mouthwashes to reduce the spread of COVID-19 through saliva. There is no potential risk to participants from saliva collection methods as it is a non-invasive method.

Where is the study run from?
The study is run from YARSI Hospital (Internal Medicine Department Clinic) (Indonesia)

When is the study starting and how long is it expected to run for?
March 2021 to October 2021

Who is funding the study?
Faculty of Dentistry Trisakti University (Indonesia)

Who is the main contact?
Dr. drg. Armelia Sari Widyarman, armeliasari@trisakti.ac.id

Contact information

Dr Armelia Sari Widyarman
Scientific

Faculty of Dentistry
Trisakti University
Jl. Kyai Tapa No.1
RT.5 / RW.9
Tomang
Grogol Petamburan
West Jakarta City
Special Capital Region of Jakarta
Jakarta
11440
Indonesia

ORCID ID	0000-0003-1435-2392
Phone	+62 (0)811929379
Email	armeliasari@trisakti.ac.id

Study information

Study design	Single-center single blind interventional randomized clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	ISRCTN12721265_PIS.pdf
Scientific title	Efficacy of commercial mouth-rinses on SARS-CoV-2 viral load in saliva: a randomized control trial in Indonesia
Study objectives	PVI-I, CPC, and NaClO₂-based mouth rinses are effective against reducing SARS-CoV-2 viral load in the saliva compared to a control water rinse and the effect will last for 6 hours. Objectives: 1. To comparatively evaluate the viral load of SARS-CoV-2 in saliva pre- and post-5-minute application of PVP-I, CPC and NaClO₂-based mouth-rinses in COVID-19 positive patients. 2. To assess the duration of efficacy of PVP-I, CPC and NaClO2-based mouth-rinses in reducing SARS-CoV-2 load in COVID-19 positive patients by the collection of saliva at 3 h and 6 h post-application of mouth-rinses.
Ethics approval(s)	Approved 25/03/2021, Institutional Review Board of Faculty of Dentistry, Trisakti University (Jl. Kyai Tapa No.1, RT.5 / RW.9, Tomang, Grogol Petamburan, West Jakarta City, Special Capital Region of Jakarta 11440, Jakarta, Indonesia; +628161908945; komisietikfkg@trisakti.ac.id), ref: 001/Dosen/KEPK/FKG/03/2021
Health condition(s) or problem(s) studied	Reducing the transmission of SARS CoV-2 virus in saliva of COVID-19 patients in Indonesia.
Intervention	The enrolled patients are randomized using Robust Randomization App (RRApp) using a block randomization technique and are allocated to four groups accordingly— PI, NaClO₂, CPC and water control group. Prior to saliva collection, patients are asked to refrain from eating, drinking, or performing oral hygiene procedures for at least 30 min. Three milliliters of saliva is collected by the passive drool technique from all the enrolled COVID-19 patients at four time points. Firstly, a baseline saliva sample is collected prior to the intervention of the mouth-rinse. Immediately after this, patients are requested to rinse their mouth with the allocated mouth-rinse for 30 seconds. Commercial mouth-rinses are prepared at the dilution and dosage recommended by respective manufacturers. In brief, in the PI group 5 ml of PI mouthwash (commercially available as Betadine Gargle and Mouthwash 1%) diluted with 5 ml of water (0.5%) is used whereas in NaClO₂ group, 15 ml of undiluted NaClO₂ mouthwash (commercially available as Oxyfresh Pro Formula) is used. In the CPC group and water control groups, 20 ml of CPC (commercially available as Pepsodent Active Defense mouthwash) and 15 ml sterile water is used, respectively. Three milliliters of saliva is collected again from all subjects five minutes after the use of mouth-rinse. In order to evaluate the duration of the efficacy of mouth-rinses, salivary samples are collected at the 3 h and 6 h post-rinsing.
Intervention type	Supplement
Primary outcome measure	Salivary CT values of SARS CoV-2 is measured using reverse-transcription polymerase chain reaction (RT-PCR) at baseline, 5 min, 3 hours and 6 hours
Secondary outcome measures	There are no secondary outcome measures
Overall study start date	25/03/2021
Completion date	20/10/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	68
Key inclusion criteria	Laboratory-confirmed COVID-19 positive patients
Key exclusion criteria	1. History of allergy to PI, NaClO₂, CPC and its relevant excipients 2. All forms of thyroid disease or current radioactive iodine treatment 3. Lithium therapy 4. Known pregnancy 5. Renal failure
Date of first enrolment	10/05/2021
Date of final enrolment	10/06/2021

Locations

Countries of recruitment

Indonesia

Study participating centre

Internal Medicine Department Clinic YARSI Hospital

Jl. Letjend Suprapto No.Kav 13
RT.10/RW.5
Cempaka Putih Timur
Cempaka Putih District
Central Jakarta City
Special Capital Region of Jakarta
Jakarta
10510
Indonesia

Sponsor information

Trisakti University
University/education

Faculty of Dentistry
Jl. Kyai Tapa No.1
RT.5 / RW.9
Tomang
Grogol Petamburan
West Jakarta City
Special Capital Region of Jakarta
Jakarta
11440
Indonesia

Phone	+62 (0)21-5672731
Email	komisietikfkg@trisakti.ac.id
Website	http://trisakti.ac.id/fkg
"ROR"	https://ror.org/019fnr381

Funders

Funder type

University/education

Universitas Trisakti
Private sector organisation / Universities (academic only)

Alternative name(s): Trisakti University
Location: Indonesia

Results and Publications

Intention to publish date	31/05/2022
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			04/05/2021	No	Yes

Additional files

ISRCTN12721265_PIS.pdf: uploaded 04/05/2021

Editorial Notes

04/05/2021: The participant information sheet was uploaded as an additional file.
19/04/2021: Trial's existence confirmed by Institutional Review Board of Faculty of Dentistry, Trisakti University.