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HalitosisNCT06219226

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

A study testing Chlorine dioxide mouthwash and Chlorhexidine mouthwash in people with Halitosis, run by Semmelweis University at 1 site in Hungary.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Halitosis
What is being tested?
Chlorine dioxide mouthwash and Chlorhexidine mouthwash
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteHungary
Study dates
18 Apr 2024to 18 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Medical history of systematic and infectious diseases (e.g., hepatitis, HIV, 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hungary1 site

  • Semmelweis University

    Budapest, Budapest, 1088

Other trials in Hungary

About this study

Official title: Hyperpure Chlorine Dioxide Versus Chlorhexidine in Intra-oral Halitosis (ODOR Trial)

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.

Conditions
Halitosis
Being tested
Chlorine dioxide mouthwash, Chlorhexidine mouthwash
Keywords
ClO2, mouth rinse, malodor
Medical subject headings
Halitosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chlorine dioxide mouthwashProcedure or surgery

    Also called Solumium Coral®

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

  • Chlorhexidine mouthwashProcedure or surgery

    Also called Curasept ADS 220, 0.2%

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

Study groups in NCT06219226
Study groupRoleWhat they receive
Chlorine dioxide mouthwashExperimentalParticipants will rinse once with hyper-pure ClO2 (0.003%) mouthwash.
Receives: Procedure: Chlorine dioxide mouthwash
Chlorhexidine mouthwashActive comparatorParticipants will rinse once with chlorhexidine-containing mouthwash (0.2%).
Receives: Procedure: Chlorhexidine mouthwash

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: immediately after the rinse and 3 hours later

Secondary outcomes (2)

  1. Changes of the volatile sulfur compounds

    with gas chromatography

    Measured: 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)

    Measured: immediately after the rinse and 3 hours later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start18 Apr 2024
  3. Primary completion18 Dec 2025 (estimated)
  4. Study completion18 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06219226
Sponsor's protocol ID
838
Status last verified
Jul 2025
First submitted
12 Jan 2024
Last updated
5 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Chlorine dioxide mouthwash and Chlorhexidine mouthwash in people with Halitosis, run by Semmelweis University at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of the organoleptic testing scores (time frame: immediately after the rinse and 3 hours later). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06219226, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

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