Short- and Long Term Antibacterial Effects of a Single Rinse With Different Mouthwashes: a Randomized Clinical Trial
Primary Purpose
Gingival Diseases, Caries
Status
Completed
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
Chlorhexidine mouthwash
Sponsored by
About this trial
This is an interventional prevention trial for Gingival Diseases focused on measuring single rinse, mouthwash, chlorine dioxide, S. mutans
Eligibility Criteria
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
Sites / Locations
- Semmelweis University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Corsodyl
Solumium Oral
Listerine Total Care
BioGate Si*CLEAN
Arm Description
Chlorhexidine
Chlorine dioxide
Essential oils, sodium fluoride, zinc chloride
Microsilver
Outcomes
Primary Outcome Measures
Salivary bacterial CFU/mL
Salivary bacterial CFU/mL
Secondary Outcome Measures
Full Information
NCT ID
NCT05178823
First Posted
December 17, 2021
Last Updated
February 23, 2022
Sponsor
Semmelweis University
1. Study Identification
Unique Protocol Identification Number
NCT05178823
Brief Title
Short- and Long Term Antibacterial Effects of a Single Rinse With Different Mouthwashes: a Randomized Clinical Trial
Official Title
Short- and Long Term Antibacterial Effects of a Single Rinse With Different Mouthwashes: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Semmelweis University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Diseases, Caries
Keywords
single rinse, mouthwash, chlorine dioxide, S. mutans
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
171 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Corsodyl
Arm Type
Active Comparator
Arm Description
Chlorhexidine
Arm Title
Solumium Oral
Arm Type
Experimental
Arm Description
Chlorine dioxide
Arm Title
Listerine Total Care
Arm Type
Experimental
Arm Description
Essential oils, sodium fluoride, zinc chloride
Arm Title
BioGate Si*CLEAN
Arm Type
Experimental
Arm Description
Microsilver
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouthwash
Other Intervention Name(s)
chlorine dioxide, essential oils, sodium fluoride, zinc chloride, microsilver
Intervention Description
Comparison of oral rinses
Primary Outcome Measure Information:
Title
Salivary bacterial CFU/mL
Description
Salivary bacterial CFU/mL
Time Frame
1 or 90 min after rinsing
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zsolt Lohinai, PHD
Organizational Affiliation
Semmelweis University, Department of Conservative Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24060558
Citation
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.
Results Reference
result
Learn more about this trial
Short- and Long Term Antibacterial Effects of a Single Rinse With Different Mouthwashes: a Randomized Clinical Trial
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