Short- and Long Term Antibacterial Effects of a Single Rinse With Different Mouthwashes: a Randomized Clinical Trial
1 other identifier
interventional
171
1 country
1
Brief Summary
Objectives: To reduce the microbial level in the aerosol created during dental procedures is essential in avoiding infections. The aim of this study was to examine the change of Streptococcus mutans (S. mutans) and the total bacterial load in human saliva in vivo after a single rinse with different mouthwashes. Material and methods: One mL unstimulated saliva was collected from volunteers with poor oral hygiene at baseline and 5 min after a one-min rinsing with Solumium Oral® (hyper-pure 0.0015% chlorine dioxide; ClO2), Listerine Total Care®, Corsodyl® (0.2% chlorhexidine-digluconate; CHX), or BioGate Si\*CLEAN for bacterial investigation. In a second study volunteers rinsed with 0.003% ClO2 or CHX for one-min and saliva was collected at baseline, after 5 and 90 min. After plating the total plate and S. mutans colony numbers were determined.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
December 17, 2021
CompletedFirst Posted
Study publicly available on registry
January 5, 2022
CompletedFebruary 24, 2022
February 1, 2022
2.3 years
December 17, 2021
February 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Salivary bacterial CFU/mL
Salivary bacterial CFU/mL
1 or 90 min after rinsing
Study Arms (4)
Corsodyl
ACTIVE COMPARATORChlorhexidine
Solumium Oral
EXPERIMENTALChlorine dioxide
Listerine Total Care
EXPERIMENTALEssential oils, sodium fluoride, zinc chloride
BioGate Si*CLEAN
EXPERIMENTALMicrosilver
Interventions
Comparison of oral rinses
Eligibility Criteria
You may qualify if:
- DMF≥10,
- minimum 5 active caries
- PSR≥2
You may not qualify if:
- smoking,
- a history of antibiotic, or probiotic use 3 months prior to sampling
- known allergy to any of the ingredients of mouthwashes being tested
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Semmelweis University
Budapest, 1088, Hungary
Related Publications (1)
Herczegh A, Gyurkovics M, Agababyan H, Ghidan A, Lohinai Z. Comparing the efficacy of hyper-pure chlorine-dioxide with other oral antiseptics on oral pathogen microorganisms and biofilm in vitro. Acta Microbiol Immunol Hung. 2013 Sep;60(3):359-73. doi: 10.1556/AMicr.60.2013.3.10.
PMID: 24060558RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zsolt Lohinai, PHD
Semmelweis University, Department of Conservative Dentistry
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2021
First Posted
January 5, 2022
Study Start
June 1, 2017
Primary Completion
September 1, 2019
Study Completion
September 1, 2020
Last Updated
February 24, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share