GingivitisPhase 2NCT05709015
Plaque Inhibitory Effect of Neutral Electrolysed Water in the Form of a Mouthwash in a 4-day Non-brushing Model
A Phase 2 study testing Neutral electrolyzed water and Chlorhexidine digluconate in people with Gingivitis, run by University of Ljubljana at 1 site in Slovenia.
Trial summary
Electrolysed water (EOW) is produced by the electrolysis of sodium chloride in an aqueous solution, producing chlorine gas at the anode and sodium hydroxide and hydrogen at the cathode. EOW is known to have antimicrobial effects against various microorganisms, including viruses, bacteria, spores and fungi. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Neutral electrolyzed water and Chlorhexidine digluconate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSlovenia
- Study dates
- 5 Jan 2023to 21 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 20 - 30 years,
- non-smoker,
- systemically healthy,
- without regular systemic medication,
- presence of at least 6 teeth in each jaw quadrant,
- plaque index < 10 % at baseline visit,
- absence of periodontal pockets measuring > 4 mm.
Who cannot join
- known allergy or suspected hypersensitivity to chlorhexidine digluconate,
- gingivitis,
- regularly use of mouthwash as part of oral hygiene routine,
- antibiotic treatment in the last 6 months or during the observation period,
- pregnancy or lactation,
- fixed or removable prosthetic devices, dental implants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Mouthwash Formulation Containing Neutral Electrolysed Water on De-novo Plaque Formation, Gingival Inflammation, MMP-8 Activity and the Oral Microbiome
Electrolysed water (EOW) is produced by the electrolysis of sodium chloride in an aqueous solution, producing chlorine gas at the anode and sodium hydroxide and hydrogen at the cathode. EOW is known to have antimicrobial effects against various microorganisms, including viruses, bacteria, spores and fungi. Its antimicrobial activity is generally attributed to its hypochloric acid content - a product of chlorine gas dissolved in water. Due to its biocompatibility, known uses of EOW include ocular disinfection, nasal irrigation and chronic cutaneous wound care. In the dental setting, it may be used as a mouthwash, disinfectant, irrigant, mouthwash or dental gel.
The aim of this study is to investigate the effect of a mouthwash containing neutral electrolyzed water on plaque accumulation (evaluated using a disclosing agent and an intraoral scanner), gingival inflammation, MMP-8 activity and the oral microbiome. In this double-blind, cross-over, 4-day experimental gingivitis model, each subject will participate in all three arms of the study. Each arm will last 4 days, during which the subjects will be asked to refrain from toothbrushing and the use of interdental cleaning devices. Instead, they will be instructed to rinse their oral cavities twice daily with either EOW, placebo or a positive control (chlorhexidine), according to a randomisation chart (each subject will receive a different mouthwash type in every arm of the study). The outcomes will be assessed at baseline and after 4 days. A washout period of at least 7 days will be implemented between each study arm.
- Conditions
- Gingivitis
- Being tested
- Neutral electrolyzed water, Placebo, Chlorhexidine digluconate
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral electrolyzed waterOther
Use of mouthwash containing neutral electrolyzed water twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.
PlaceboDrug
Use of mouthwash containing placebo twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.
Chlorhexidine digluconateDrug
Use of mouthwash containing chlorhexidine digluconate twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Based on a randomisation table, each participant will use either a mouthwash containing neutral electrolyzed water, placebo, or chlorhexidine digluconate twice a day instead of tooth brushing and flossing for 4 days. Each subject will receive each mouthwash type only once during the study period (he/she will receive a different mouthwash type in every arm of the study based on a randomisation table). Receives: Other: Neutral electrolyzed water; Drug: Placebo; Drug: Chlorhexidine digluconate |
| 2 | Other | Based on a randomisation table, each participant will use either a mouthwash containing neutral electrolyzed water, placebo, or chlorhexidine digluconate twice a day instead of tooth brushing and flossing for 4 days. Each subject will receive each mouthwash type only once during the study period (he/she will receive a different mouthwash type in every arm of the study based on a randomisation table). Receives: Other: Neutral electrolyzed water; Drug: Placebo; Drug: Chlorhexidine digluconate |
| 3 | Other | Based on a randomisation table, each participant will use either a mouthwash containing neutral electrolyzed water, placebo, or chlorhexidine digluconate twice a day instead of tooth brushing and flossing for 4 days. Each subject will receive each mouthwash type only once during the study period (he/she will receive a different mouthwash type in every arm of the study based on a randomisation table). Receives: Other: Neutral electrolyzed water; Drug: Placebo; Drug: Chlorhexidine digluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D plaque score
Differences in plaque scores evaluated by optical scanning
Measured: baseline, 4 days
Plaque index
Differences on plaque score evaluated using the Turesky Modification of the Quigley-Hein Plaque Index
Measured: baseline, 4 days
Secondary outcomes (3)
Modified Gingival Index
Differences in the gingival index evaluated using the Lobene Modified Gingival Index
Measured: baseline, 4 days
Microbiologic profile of gingival crevicular fluid
To determine if the mouthwashes effect the presence of the most relevant periodontal pathogens (e. g. Aggregibacter actinomycetemcomitans) in gingival crevicular fluid
Measured: baseline, 4 days
MMP-8 in gingival crevicular fluid
To determine if the mouthwashes effect the amount of MMP-8 in gingival crevicular fluid
Measured: baseline, 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start5 Jan 2023
- Primary completion21 Feb 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709015
- Sponsor's protocol ID
- EOWG
- Status last verified
- Jan 2023
- First submitted
- 23 Jan 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Povsic K, Munjakovic H, Zayed N, Teughels W, Seme K, Fidler A, Gaspersic R. Electrolyzed saline as an alternative to chlorhexidine: Antimicrobial and biofilm volume outcomes in a 4-day non-brushing randomized controlled clinical trial. J Periodontol. 2026 Jun;97(6):1231-1242. doi: 10.1002/jper.70070. Epub 2026 Feb 2.
PubMed 41627021
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Mouthwash Formulation Containing Neutral Electrolysed Water on De-novo Plaque Formation, Gingival Inflammation, MMP-8 Activity and the Oral Microbiome
- ClinicalTrials.gov ID
- NCT05709015
- Acronym / sponsor ID
- EOWG
- Conditions
- Gingivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electrolysed water (EOW) is produced by the electrolysis of sodium chloride in an aqueous solution, producing chlorine gas at the anode and sodium hydroxide and hydrogen at the cathode. EOW is known to have antimicrobial effects against various microorganisms, including viruses, bacteria, spores and fungi. Its antimicrobial activity is generally attributed to its hypochloric acid content - a product of chlorine gas dissolved in water. Due to its biocompatibility, known uses of EOW include ocular disinfection, nasal irrigation and chronic cutaneous wound care. In the dental setting, it may be used as a mouthwash, disinfectant, irrigant, mouthwash or dental gel.
The aim of this study is to investigate the effect of a mouthwash containing neutral electrolyzed water on plaque accumulation (evaluated using a disclosing agent and an intraoral scanner), gingival inflammation, MMP-8 activity and the oral microbiome. In this double-blind, cross-over, 4-day experimental gingivitis model, each subject will participate in all three arms of the study. Each arm will last 4 days, during which the subjects will be asked to refrain from toothbrushing and the use of interdental cleaning devices. Instead, they will be instructed to rinse their oral cavities twice daily with either EOW, placebo or a positive control (chlorhexidine), according to a randomisation chart (each subject will receive a different mouthwash type in every arm of the study). The outcomes will be assessed at baseline and after 4 days. A washout period of at least 7 days will be implemented between each study arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Neutral electrolyzed water, Drug: Placebo, Drug: Chlorhexidine digluconateBased on a randomisation table, each participant will use either a mouthwash containing neutral electrolyzed water, placebo, or chlorhexidine digluconate twice a day instead of tooth brushing and flossing for 4 days. Each subject will receive each mouthwash type only once during the study period (he/she will receive a different mouthwash type in every arm of the study based on a randomisation table). |
| 2 | Other | Other: Neutral electrolyzed water, Drug: Placebo, Drug: Chlorhexidine digluconateBased on a randomisation table, each participant will use either a mouthwash containing neutral electrolyzed water, placebo, or chlorhexidine digluconate twice a day instead of tooth brushing and flossing for 4 days. Each subject will receive each mouthwash type only once during the study period (he/she will receive a different mouthwash type in every arm of the study based on a randomisation table). |
| 3 | Other | Other: Neutral electrolyzed water, Drug: Placebo, Drug: Chlorhexidine digluconateBased on a randomisation table, each participant will use either a mouthwash containing neutral electrolyzed water, placebo, or chlorhexidine digluconate twice a day instead of tooth brushing and flossing for 4 days. Each subject will receive each mouthwash type only once during the study period (he/she will receive a different mouthwash type in every arm of the study based on a randomisation table). |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age 20 - 30 years,
- non-smoker,
- systemically healthy,
- without regular systemic medication,
- presence of at least 6 teeth in each jaw quadrant,
Key exclusion criteria (6 listed)
- known allergy or suspected hypersensitivity to chlorhexidine digluconate,
- gingivitis,
- regularly use of mouthwash as part of oral hygiene routine,
- antibiotic treatment in the last 6 months or during the observation period,
- pregnancy or lactation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neutral electrolyzed waterUse of mouthwash containing neutral electrolyzed water twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices. | Other | 1, 2, 3 |
| PlaceboUse of mouthwash containing placebo twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices. | Drug | 1, 2, 3 |
| Chlorhexidine digluconateUse of mouthwash containing chlorhexidine digluconate twice daily for 4 consecutive days instead of tooth brushing and usage of interdental cleaning devices. | Drug | 1, 2, 3 |
Primary outcome
3D plaque score
Time frame: baseline, 4 days
Differences in plaque scores evaluated by optical scanning
Plaque index
Time frame: baseline, 4 days
Differences on plaque score evaluated using the Turesky Modification of the Quigley-Hein Plaque Index
3 secondary outcomes
Modified Gingival Index
Time frame: baseline, 4 days
Microbiologic profile of gingival crevicular fluid
Time frame: baseline, 4 days
MMP-8 in gingival crevicular fluid
Time frame: baseline, 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Derived from this study: PubMed 41627021Povsic K, Munjakovic H, Zayed N, Teughels W, Seme K, Fidler A, Gaspersic R. Electrolyzed saline as an alternative to chlorhexidine: Antimicrobial and biofilm volume outcomes in a 4-day non-brushing randomized controlled clinical trial. J Periodontol. 2026 Jun;97(6):1231-1242. doi: 10.1002/jper.70070. Epub 2026 Feb 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neutral electrolyzed water and Chlorhexidine digluconate in people with Gingivitis, run by University of Ljubljana at 1 site in Slovenia.
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 7 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: finished, as of the sponsor's last update on 13 Jul 2023. 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 Slovenia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
3D plaque score (time frame: baseline, 4 days). The study lists 2 primary outcomes in all. 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 NCT05709015, which also lists 1 linked publication.
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 13 Jul 2023.