Short- and Long Term Antibacterial Effects of a Single Rinse With Different Mouthwashes: a Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sample and procedure In the first study we collected 1 mL of unstimulated whole saliva by spitting participants into a sterile Eppendorf tube at baseline and 5 min after rinsing with 5 mL of 4 different types of commercially available mouthwashes from identical opaque-coded flasks. From our clinical ambulance randomly selected 145 patients assessed for eligibility. Inclusion criteria were: DMF≥10, minimum 5 active caries and PSR≥2. Exclusion criteria were: smoking, a history of antibiotic, or probiotic use 3 months prior to sampling, or known allergy to any of the ingredients of mouthwashes being tested. Twenty five patients were excluded (19 of these based on the criteria above and 6 refused to participate). One hundred and twenty volunteering patients (42±8 years) with poor oral hygiene were selected to participate in the study. All eligible subjects were given oral and written information about the products and the purpose of the study and were asked to sign an informed consent form. Volunteers were randomly assigned to the tests and the positive control (Corsodyl®) groups. Randomization was performed using computer-generated random numbers. The randomization and the allocation of rinse aids were carried out by a person not directly involved in the research project. The volunteers rinsed for 1 min, with a 20-fold dilution of hyper-pure 0.03 % ClO2 (Solumium Oral®, final concentration: 0.0015%), Corsodyl® (0.2% CHX), Listerine Total Care® (essential oils, sodium fluoride, zinc chloride), or BioGate Si*CLEAN® (microsilver) (30 individuals in each mouthwash group).
In the second study randomly chosen 26 medical student volunteers (20±3 years) rinsed with 5 mL of 10-fold diluted hyper-pure ClO2 (final concentration: 0.003%) or Corsodyl® for 1 min, and their unstimulated whole saliva was collected as above at base line and after 5 and 90 minutes (13 individuals in each mouthwash group). The restrictions on the oral hygiene of the volunteers were: DMF≥5, minimum 1 active caries, PSR≥1 and exclusion categories were the same as in the first study. The management of eligible subjects, their randomization and the allocation of rinse aids in same opaque-coded flasks were also exactly identical to the first study. Eleven volunteers were excluded from this study (9 of these based on the criteria above and 2 refused to participate).
The saliva samples were stored in Eppendorf tubes used for collection at air-conditioned room temperature and processed within two hours. A dilution series was prepared from the samples in physiological salt solution. To determine our pre-specified primary outcome, the total bacterial count and the S. mutans number (CFU/ml) blood and Mitis-Salivarius (Difco, Becton-Dickinson, Hungary) agars were inoculated, respectively. Cultivation was carried out at 37 °C, 5 % CO2 and took 2 days. The CFU counting researcher did not know which plates were exposed to each treatment.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Budapest, Hungary, 1088
- Semmelweis University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- DMF≥10,
- minimum 5 active caries
- PSR≥2
Exclusion Criteria:
- smoking,
- a history of antibiotic, or probiotic use 3 months prior to sampling
- known allergy to any of the ingredients of mouthwashes being tested
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Corsodyl
Chlorhexidine
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Comparison of oral rinses
Other Names:
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Experimental: Solumium Oral
Chlorine dioxide
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Comparison of oral rinses
Other Names:
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Experimental: Listerine Total Care
Essential oils, sodium fluoride, zinc chloride
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Comparison of oral rinses
Other Names:
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Experimental: BioGate Si*CLEAN
Microsilver
|
Comparison of oral rinses
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Salivary bacterial CFU/mL
Time Frame: 1 or 90 min after rinsing
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Salivary bacterial CFU/mL
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1 or 90 min after rinsing
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zsolt Lohinai, PHD, Semmelweis University, Department of Conservative Dentistry
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Solumium
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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