NCT04941131

Brief Summary

Existing evidence confirmed that saliva and oral cavity to be a reservoir for SARS-CoV-2. In dental clinic aerosol-producing-procedures pose a significant risk for transmission of the infection . It is very important to minimize the risk of transmission in dental office reducing the load of SARS-CoV-2 in saliva if possible, in suspect or conformed cases. Preprocedural mouth rises have been used widely to minimize the number of oral microorganisms. Multiple studies confirmed the efficacy of those mouth rinses in reducing the possibility of transmission of SARS-CoV-2 infection .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_4 covid19

Timeline
Completed

Started May 2023

Shorter than P25 for phase_4 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
1.9 years until next milestone

Study Start

First participant enrolled

May 18, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 12, 2025

Completed
Last Updated

June 12, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

June 24, 2021

Results QC Date

April 9, 2025

Last Update Submit

May 23, 2025

Conditions

COVID-19

Keywords

Mouth WashViral Load

Outcome Measures

Primary Outcomes (1)

  • E Genes

    Gene viral load serves as a proxy measure for the presence and quantity of SARS-CoV-2 virus in patient samples. Since the E gene is expressed early and reliably during viral replication, changes in its detected levels reflect the dynamics of viral presence. Quantified using RT-qPCR, with results expressed as cycle threshold (Ct) values-the number of amplification cycles required to detect the gene above background levels. Lower Ct values indicate higher viral loads.

    6 months

Secondary Outcomes (1)

  • S Genes

    6 months

Study Arms (4)

chlorhexidine digluconate mouthwash

EXPERIMENTAL
Drug: Chlorhexidine digluconate, povidone iodine

chlorhexidine digluconate lozenges

EXPERIMENTAL
Drug: Chlorhexidine digluconate, povidone iodine

povidone iodine mouthwash

EXPERIMENTAL
Drug: Chlorhexidine digluconate, povidone iodine

tap water

NO INTERVENTION

Interventions

Chlorhexidine digluconate, povidone iodineDRUG

This is a mouth wash that can be used over the counter.

chlorhexidine digluconate lozengeschlorhexidine digluconate mouthwashpovidone iodine mouthwash

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A history of positive nasal swabs for SARS-CoV-2 based on reverse-transcription polymerase chain reaction (RT-PCR) assays.

You may not qualify if:

  • History of allergy to any of the products that will be used
  • known pregnancy
  • Renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz University , Faculty of Dentistry

Jeddah, Saudi Arabia

Location

Related Publications (1)

  • Natto ZS, Bakhrebah MA, Afeef M, Al-Harbi S, Nassar MS, Alhetheel AF, Ashi H. The short-term effect of different chlorhexidine forms versus povidone iodine mouth rinse in minimizing the oral SARS-CoV-2 viral load: An open label randomized controlled clinical trial study. Medicine (Baltimore). 2022 Jul 29;101(30):e28925. doi: 10.1097/MD.0000000000028925.

    PMID: 35905275DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

chlorhexidine gluconatePovidone-Iodine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Dr Zuhair Natto
Organization
King Abdulaziz University
znatto@kau.edu.sa
9666943899

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of research unit and associate professor

Study Record Dates

First Submitted

June 24, 2021

First Posted

June 28, 2021

Study Start

May 18, 2023

Primary Completion

July 25, 2023

Study Completion

August 20, 2023

Last Updated

June 12, 2025

Results First Posted

June 12, 2025

Record last verified: 2025-05

Locations

SA(1)