ClinicalTrials.gg
Enrolling by invitationNCT06219226Updated Aug 5, 2025

Investigating the Effect of Chlorine Dioxide and Chlorhexidine Mouthwash on Bad Breath

An interventional study of Chlorine dioxide mouthwash and Chlorhexidine mouthwash in Halitosis, sponsored by Semmelweis University. Enrolling by invitation at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-05.

Sponsored by Semmelweis University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The ODOR trial will be a single-centric, double-blinded, parallel-group, double-armed pilot randomized controlled trial with a non-inferiority design. The efficacy of hyperpure chlorine dioxide will be compared to chlorhexidine mouthwash. The short-term effect of the mouthwashes will be investigated in a 3-hour-long period. The primary endpoint will be the changes in the organoleptic testing scores.

Read the detailed description

Eligible patients will be randomly allocated to two groups in a 1:1 ratio. Necessary data will be collected with prespecified electronic case report forms (REDCap). The statistician will calculate the sample size at the end of the pilot investigation of the first 30-30 patients. If feasible, investigators will continue the study by enrolling more patients.

02

Conditions studied

  • Halitosis

Browse trials for

Keywords

  • ClO2
  • mouth rinse
  • malodor
03

In context

Halitosis

93 studies on the registry are indexed under Halitosis; 17 are open to participants now.

This study's planned enrollment of 60 is above the median of 45 across 79 interventional studies indexed under Halitosis.

Browse Halitosis studies →

Lead sponsor

Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Organoleptic test score (OLS)>=2 for IOH
  • Patients with at least 20 teeth
  • 8 hours of scented oral hygiene product usage, 4 hours of eating, and 2 hours of drinking restriction
  • on the day of investigation, restriction of alcohol, caffeine, perfume usage, and food intake with characteristic smell

Exclusion criteria

Exclusion Criteria:

  • Medical history of systematic and infectious diseases (e.g., hepatitis, , tuberculosis).
  • Antibiotic use within the month before the study's start or during the trial or any regular medication
  • Extraoral halitosis (will be distinguished by observing the nasal breath)
  • Eat foods (like garlic) linked to oral malodor on the day before and the sampling day, as well as wear heavily fragrant cosmetics on that day.
  • Patients with removable dentures
  • Smokers (Cigars, Cigarettes, Pipes, Chewing tobacco, e-cigarette, or vaping products used in the last month)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Chlorine dioxide mouthwash

    Participants will rinse once with hyper-pure ClO2 (0.003%) mouthwash.

    Procedure: Chlorine dioxide mouthwash

  • Active comparator
    Chlorhexidine mouthwash

    Participants will rinse once with chlorhexidine-containing mouthwash (0.2%).

    Procedure: Chlorhexidine mouthwash

Interventions

  • ProcedureChlorine dioxide mouthwash

    This one rinsing will last 2x15 seconds(2x12,5ml).

    Also known as: Solumium Coral®

  • ProcedureChlorhexidine mouthwash

    This one rinsing will last 2x15 seconds(2x12,5ml).

    Also known as: Curasept ADS 220, 0.2%

06

What researchers measure

Primary outcomes

  1. Changes of the organoleptic testing scores

    (gold standard 6-point (0-5) intensity scale. The examiner rates it 0 when the patient has no halitosis, and 5 when it is very severe)

    Time frame: immediately after the rinse and 3 hours later

Secondary outcomes

  1. Changes of the volatile sulfur compounds

    with gas chromatography

    Time frame: immediately after the rinse and 3 hours later

  2. Self-perceived halitosis

    with a visual analog scale ratings (0-100, 0 = No Pain, 100 = Worst Possible Pain)

    Time frame: immediately after the rinse and 3 hours later

Other outcomes

  1. Side effects

    (e.g., tooth discoloration, signs of allergic reactions, subjective experiences: unpleasant taste, false taste or burning sensation, pain, changes in salivary flow)

    Time frame: immediately after the rinse and 3 hours later

07

Study locations

1 site
08

References and documents

Publications

  • Szalai E, Tajti P, Szabo B, Hegyi P, Czumbel LM, Shojazadeh S, Varga G, Nemeth O, Keremi B. Daily use of chlorine dioxide effectively treats halitosis: A meta-analysis of randomised controlled trials. PLoS One. 2023 Jan 12;18(1):e0280377. doi: 10.1371/journal.pone.0280377. eCollection 2023. PubMed 36634129 ↗
  • Noszticzius Z, Wittmann M, Kaly-Kullai K, Beregvari Z, Kiss I, Rosivall L, Szegedi J. Chlorine dioxide is a size-selective antimicrobial agent. PLoS One. 2013 Nov 5;8(11):e79157. doi: 10.1371/journal.pone.0079157. eCollection 2013. PubMed 24223899 ↗
  • Kumbargere Nagraj S, Eachempati P, Uma E, Singh VP, Ismail NM, Varghese E. Interventions for managing halitosis. Cochrane Database Syst Rev. 2019 Dec 11;12(12):CD012213. doi: 10.1002/14651858.CD012213.pub2. PubMed 31825092 ↗
  • Szalai EA, Teutsch B, Babay V, Galvacs A, Hegyi P, Harsfalvi P, Pal R, Varga G, Lohinai ZM, Keremi B. Hyperpure chlorine dioxide versus chlorhexidine in intra-oral halitosis (ODOR trial) - protocol of a double-blinded, double-arm, parallel non-inferiority pilot randomized controlled trial. BDJ Open. 2024 May 20;10(1):35. doi: 10.1038/s41405-024-00221-8. PubMed 38769314 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Dec 2025, 20 months after the start.

Of 35 non-industry interventional studies with no phase under Halitosis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's planned 20 months is above that.

Counting every sponsor, half of 43 studies reached it within 10 months; a quarter within 3 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2024
First posted
Jan 23, 2024
StartActual
Apr 18, 2024
Primary completionEst.
Dec 18, 2025
CompletionEst.
Dec 18, 2025
Last update
Aug 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06219226
Responsible party
Eszter Á Szalai, DMD (Assistant lecturer, Semmelweis University) — Principal investigator
First posted
Jan 23, 2024
Start date
Apr 18, 2024
Primary completion
Dec 18, 2025 (estimated)
Completion
Dec 18, 2025 (estimated)
Last update
Aug 5, 2025

Oversight

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

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