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CompletedNCT05178823Updated Feb 24, 2022

Short- and Long Term Antibacterial Effects of a Single Rinse With Different Mouthwashes: a Randomized Clinical Trial

A Phase 4 interventional study of Chlorhexidine mouthwash in Gingival Diseases and Caries, sponsored by Semmelweis University. Completed at 1 site in Hungary. Per ClinicalTrials.gov, last updated 2022-02-24.

Sponsored by Semmelweis University · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 6 months after the study started (first participant enrolled Jun 2017, registered Dec 2021).
Phase
Phase 4
Study type
Interventional
Enrollment
171
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gingival Diseases
  • Caries

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Keywords

  • single rinse
  • mouthwash
  • chlorine dioxide
  • S. mutans
03

In context

Gingival Diseases

84 studies on the registry are indexed under Gingival Diseases; 25 are open to participants now.

This study's enrollment of 171 is above the median of 46 across 67 interventional studies indexed under Gingival Diseases.

Browse Gingival Diseases studies →

Lead sponsor

Semmelweis University is the lead sponsor of 136 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • DMF≥10,
  • minimum 5 active caries
  • PSR≥2

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
171 participants (actual)

Study arms

  • Active comparator
    Corsodyl

    Chlorhexidine

    Drug: Chlorhexidine mouthwash

  • Experimental
    Solumium Oral

    Chlorine dioxide

    Drug: Chlorhexidine mouthwash

  • Experimental
    Listerine Total Care

    Essential oils, sodium fluoride, zinc chloride

    Drug: Chlorhexidine mouthwash

  • Experimental
    BioGate Si*CLEAN

    Microsilver

    Drug: Chlorhexidine mouthwash

Interventions

  • DrugChlorhexidine mouthwash

    Comparison of oral rinses

    Also known as: chlorine dioxide, essential oils, sodium fluoride, zinc chloride, microsilver

06

What researchers measure

Primary outcomes

  1. Salivary bacterial CFU/mL

    Salivary bacterial CFU/mL

    Time frame: 1 or 90 min after rinsing

07

Study locations

1 site
  • Semmelweis University
    Budapest, 1088, Hungary
08

References and documents

Publications

  • 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. PubMed 24060558 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05178823
Lead sponsor
Semmelweis University
Responsible party
Sponsor
First posted
Jan 5, 2022
Start date
Jun 1, 2017
Primary completion
Sep 1, 2019
Completion
Sep 1, 2020
Last update
Feb 24, 2022

Study contacts

Zsolt Lohinai, PHD
principal investigator · Semmelweis University, Department of Conservative Dentistry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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