Dental PlaqueNCT06589193
Comparison of the Clinical and Microbiological Effects of CHX and HOCl Containing Mouthwashes
A study testing Hypochlorous acid 0.02% mouthwash and Chlorhexidine gluconate 0.2% mouthwash in people with Dental Plaque, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This study compared two mouthwashes, containing hypochlorous acid (HOCl) or chlorhexidine (CHX), for their effects on dental plaque accumulation, gum bleeding, tooth staining, and bacteria in dental plaque. Participants used each mouthwash during a separate four-day period, with a washout period between treatments. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Hypochlorous acid 0.02% mouthwash and Chlorhexidine gluconate 0.2% mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Mar 2022to 19 Apr 2022
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy.
- Aged 18-65 years.
- Having at least 22 natural teeth.
- Nonsmoker.
- Willing to abstain from alcohol throughout the study.
Who cannot join
- Presence of periodontitis or gingivitis.
- Pregnancy or breastfeeding.
- Use of medications that may affect periodontal status.
- Antibiotic or anti-inflammatory medication use within the previous six months.
- Use of antimicrobial mouth rinses, gels, or chewing gums within the previous three months.
- Known allergy to any component of the study mouth rinses.
Show all 10Show fewer
- Presence of tongue conditions, such as geographic tongue or hairy tongue.
- Periodontal probing depths of 4 mm or greater.
- Gingival recession of 2 mm or greater.
- Use of fixed or removable dental prostheses, including single crowns, or orthodontic appliances.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Faculty of Dentistry
Ankara, 06000
About this study
This study compared two mouthwashes, containing hypochlorous acid (HOCl) or chlorhexidine (CHX), for their effects on dental plaque accumulation, gum bleeding, tooth staining, and bacteria in dental plaque. Participants used each mouthwash during a separate four-day period, with a washout period between treatments. Participants also evaluated their experience with each mouthwash using a questionnaire.
Read the detailed description
This single-center, randomized controlled crossover study compared mouthwashes containing 0.02% hypochlorous acid (HOCl) and 0.2% chlorhexidine (CHX) using a four-day plaque regrowth model. Thirty participants were enrolled, and 26 completed both treatment periods.
Each mouthwash was used twice daily, with 10 mL rinsed for one minute, during a four-day period. The treatment periods were separated by a 14-day washout period. Professional prophylaxis was performed at the beginning of each treatment period. Participants refrained from toothbrushing and interdental cleaning during the treatment periods.
Clinical assessments included the Modified Plaque Index, bleeding on probing, and the Modified Stain Index. Supragingival plaque samples were collected at the end of each treatment period for microbiological analysis, including bacterial colony counts and identification by MALDI-TOF mass spectrometry. Participants completed a questionnaire evaluating their experience with each mouthwash and indicated their final preference.
- Conditions
- Dental Plaque
- Being tested
- Hypochlorous acid 0.02% mouthwash, Chlorhexidine gluconate 0.2% mouthwash
- Keywords
- Hypochlorous acid, chlorhexidine gluconate, antiplaque, anti-inflammatory, mouthwash, dental biofilm, plaque regrowth, crossover study
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypochlorous acid 0.02% mouthwashOther
Rinse with 10 mL for one minute, twice daily for four days.
Chlorhexidine gluconate 0.2% mouthwashOther
Rinse with 10 mL for one minute, twice daily for four days.
| Study group | Role | What they receive |
|---|---|---|
| HOCl followed by CHX | Experimental | Participants used 0.02% hypochlorous acid mouthwash for four days, followed by a 14-day washout period, and then 0.2% chlorhexidine gluconate mouthwash for four days. Each mouthwash was used twice daily, with 10 mL rinsed for one minute. Receives: Other: Hypochlorous acid 0.02% mouthwash; Other: Chlorhexidine gluconate 0.2% mouthwash |
| CHX followed by HOCl | Experimental | Participants used 0.2% chlorhexidine gluconate mouthwash for four days, followed by a 14-day washout period, and then 0.02% hypochlorous acid mouthwash for four days. Each mouthwash was used twice daily, with 10 mL rinsed for one minute. Receives: Other: Hypochlorous acid 0.02% mouthwash; Other: Chlorhexidine gluconate 0.2% mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Plaque Index
Dental plaque was assessed using the modified Silness and Löe Plaque Index at six sites per tooth. Each site was scored from 0 (no plaque) to 3 (abundant plaque). Mean scores were calculated for the full mouth and 12 anatomical regions and compared between the HOCl and CHX treatment periods. Mean scores range from 0 to 3; higher scores indicate greater plaque accumulation.
Measured: At the end of each four-day treatment period.
Secondary outcomes (3)
Total culturable bacterial count in supragingival plaque
Total culturable bacterial counts were measured in supragingival plaque samples collected from molar teeth and expressed as colony-forming units per milliliter (CFU/mL). Counts were compared between the HOCl and CHX treatment periods.
Measured: At the end of each four-day treatment period.
Bleeding on Probing (BOP)
Bleeding was assessed at six sites per tooth using a periodontal probe. Sites showing bleeding within 30 seconds after probing were recorded as positive. BOP was calculated as the number of bleeding sites divided by the total number of examined sites, multiplied by 100. Full-mouth and regional percentages were calculated. Scores range from 0% to 100%; higher values indicate more gingival bleeding.
Measured: At the end of each four-day treatment period.
Modified Stain Index (MSI)
Extrinsic tooth staining was assessed in four regions on each buccal and lingual/palatal tooth surface. Intensity was scored from 0 to 3. Area was scored from 1 to 3 only when intensity was 2 or 3, using the region-specific criteria of Macpherson et al. (2000). For intensity scores of 1, the intensity × area value was defined as 1. The participant-level MSI was calculated by averaging these values across examined regions, with a range of 0-9. Higher scores indicate greater staining.
Measured: At the end of each four-day treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start28 Mar 2022
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
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 Dental PlaqueStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 4-day plaque regrowth study model
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap Bilgin Çetin, Baskent University
- Investigators
- Mehtap Bilgin Cetin, Associate Professor, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589193
- Sponsor's protocol ID
- MR1234
- Status last verified
- Nov 2026
- First submitted
- 29 Aug 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding sharing individual participant data has not yet been made.
Publications
Lafaurie GI, Zaror C, Diaz-Baez D, Castillo DM, De Avila J, Trujillo TG, Calderon-Mendoza J. Evaluation of substantivity of hypochlorous acid as an antiplaque agent: A randomized controlled trial. Int J Dent Hyg. 2018 Nov;16(4):527-534. doi: 10.1111/idh.12342. Epub 2018 Apr 2.
PubMed 29608039
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical and Microbiological Effects of CHX and HOCl Containing Mouthwashes
- ClinicalTrials.gov ID
- NCT06589193
- Acronym / sponsor ID
- MR1234
- Conditions
- Dental Plaque
- Keywords
- Hypochlorous acid, chlorhexidine gluconate, antiplaque, anti-inflammatory, mouthwash, dental biofilm, plaque regrowth, crossover study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 19 Sep 2024 (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.
This study compared two mouthwashes, containing hypochlorous acid (HOCl) or chlorhexidine (CHX), for their effects on dental plaque accumulation, gum bleeding, tooth staining, and bacteria in dental plaque. Participants used each mouthwash during a separate four-day period, with a washout period between treatments. Participants also evaluated their experience with each mouthwash using a questionnaire.
Detailed description
This single-center, randomized controlled crossover study compared mouthwashes containing 0.02% hypochlorous acid (HOCl) and 0.2% chlorhexidine (CHX) using a four-day plaque regrowth model. Thirty participants were enrolled, and 26 completed both treatment periods.
Each mouthwash was used twice daily, with 10 mL rinsed for one minute, during a four-day period. The treatment periods were separated by a 14-day washout period. Professional prophylaxis was performed at the beginning of each treatment period. Participants refrained from toothbrushing and interdental cleaning during the treatment periods.
Clinical assessments included the Modified Plaque Index, bleeding on probing, and the Modified Stain Index. Supragingival plaque samples were collected at the end of each treatment period for microbiological analysis, including bacterial colony counts and identification by MALDI-TOF mass spectrometry. Participants completed a questionnaire evaluating their experience with each mouthwash and indicated their final preference.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 4-day plaque regrowth study model
| Arm | Type | Receives |
|---|---|---|
| HOCl followed by CHX | Experimental | Other: Hypochlorous acid 0.02% mouthwash, Other: Chlorhexidine gluconate 0.2% mouthwashParticipants used 0.02% hypochlorous acid mouthwash for four days, followed by a 14-day washout period, and then 0.2% chlorhexidine gluconate mouthwash for four days. Each mouthwash was used twice daily, with 10 mL rinsed for one minute. |
| CHX followed by HOCl | Experimental | Other: Hypochlorous acid 0.02% mouthwash, Other: Chlorhexidine gluconate 0.2% mouthwashParticipants used 0.2% chlorhexidine gluconate mouthwash for four days, followed by a 14-day washout period, and then 0.02% hypochlorous acid mouthwash for four days. Each mouthwash was used twice daily, with 10 mL rinsed for one minute. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy.
- Aged 18-65 years.
- Having at least 22 natural teeth.
- Nonsmoker.
- Willing to abstain from alcohol throughout the study.
Key exclusion criteria (10 listed)
- Presence of periodontitis or gingivitis.
- Pregnancy or breastfeeding.
- Use of medications that may affect periodontal status.
- Antibiotic or anti-inflammatory medication use within the previous six months.
- Use of antimicrobial mouth rinses, gels, or chewing gums within the previous three months.
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 |
|---|---|---|
| Hypochlorous acid 0.02% mouthwashRinse with 10 mL for one minute, twice daily for four days. | Other | CHX followed by HOCl, HOCl followed by CHX |
| Chlorhexidine gluconate 0.2% mouthwashRinse with 10 mL for one minute, twice daily for four days. | Other | CHX followed by HOCl, HOCl followed by CHX |
Primary outcome
Modified Plaque Index
Time frame: At the end of each four-day treatment period.
Dental plaque was assessed using the modified Silness and Löe Plaque Index at six sites per tooth. Each site was scored from 0 (no plaque) to 3 (abundant plaque). Mean scores were calculated for the full mouth and 12 anatomical regions and compared between the HOCl and CHX treatment periods. Mean scores range from 0 to 3; higher scores indicate greater plaque accumulation.
3 secondary outcomes
Total culturable bacterial count in supragingival plaque
Time frame: At the end of each four-day treatment period.
Bleeding on Probing (BOP)
Time frame: At the end of each four-day treatment period.
Modified Stain Index (MSI)
Time frame: At the end of each four-day treatment period.
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 4 Nov 2026.
- Background: PubMed 29608039Lafaurie GI, Zaror C, Diaz-Baez D, Castillo DM, De Avila J, Trujillo TG, Calderon-Mendoza J. Evaluation of substantivity of hypochlorous acid as an antiplaque agent: A randomized controlled trial. Int J Dent Hyg. 2018 Nov;16(4):527-534. doi: 10.1111/idh.12342. Epub 2018 Apr 2.
- Individual participant dataSharing planned: Undecided. A decision regarding sharing individual participant data has not yet been made.
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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.
Mehtap Bilgin Cetin, Associate Professor principal investigator
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypochlorous acid 0.02% mouthwash and Chlorhexidine gluconate 0.2% mouthwash in people with Dental Plaque, run by Baskent University at 1 site in Turkey (Türkiye).
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 5 inclusion and 10 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 4 Nov 2026. 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 Turkey (Türkiye). 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?
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?
Modified Plaque Index (time frame: At the end of each four-day treatment period.). 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 NCT06589193, 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 4 Nov 2026.