Oral Mucosal DisorderPhase 4NCT06942026
Effects of Chlorhexidine Gluconate, Ozonated Water and Hypochlorous Acid Solutions Used in the Oral Care of Patients Supported by Mechanical Ventilation on the Integrity of the Oral Mucosa
A Phase 4 study of Oral Mucosal Disorder, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical trial is to learn whether ozonated water and hypochlorous acid solution can restore the integrity of the oral mucosa. In addition, the investigators will learn about the safety of ozonated water and hypochlorous acid solution. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Mucosal Disorder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Apr 2025to 30 Sep 2025
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be between the ages of 18-65,
- Have been on mechanical ventilation for at least 24 hours,
- Have no intolerance or allergy to the solutions,
- Agree to participate in the study
Who cannot join
- Having a contraindication for oral care
- Not agreeing to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this clinical trial is to learn whether ozonated water and hypochlorous acid solution can restore the integrity of the oral mucosa. In addition, the investigators will learn about the safety of ozonated water and hypochlorous acid solution. The main questions that participants need to answer are:
What medical conditions do participants have while taking ozonated water and hypochlorous acid solution?
Read more
Investigators will compare ozonated water and hypochlorous acid solution with 0.12% chlorhexidine gluconate solution to see if it helps to restore the integrity of the oral mucosa.
Participants:
Participants will be asked to agree to receive oral care 4 times a day, every day for 1 week.
- Conditions
- Oral Mucosal Disorder
- Being tested
- Control 1
- Keywords
- oral care, Intensive care unit, ozonated water, Oral Mucous Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control 1Drug
Also called %0.12 chlorhexidine gluconate
Researchers will perform oral care with ozonated water and hypochlorous acid solution to restore oral mucous membrane integrity.
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Ozonated water Receives: Drug: Control 1 |
| Experimental 2 | Experimental | hypochlorous acid Receives: Drug: Control 1 |
| Control 1 | Active comparator | %0.12 chlorhexidine gluconate Receives: Drug: Control 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral assessment guide
The Oral Assessment Scale will be used to assess patients' oral mucosa before oral care is provided. his scale has sections on the lips, mucosa, tongue, teeth and saliva. Each section is scored from1 to 4, and the total score is between 5 and 20. A score of 5 is assessed as normal oral mucosa, 6-10 as slight dysfunction, 11-15 as moderate dysfunction and 16-20 as severe dysfunction.
Measured: From enrollment to the end of treatment at 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start27 Apr 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral Mucosal DisorderStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sercan Özdemir, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942026
- Sponsor's protocol ID
- 1758-1738-28-08-2024
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ozdemir S, Turk G. The effect of different concentrations of chlorhexidine on microbial colonization: A double-blinded randomized controlled study. Int J Nurs Pract. 2022 Apr;28(2):e13025. doi: 10.1111/ijn.13025. Epub 2021 Oct 23.
PubMed 34687483Turk G, Ozdemir S. Comparative Effects of Chlorhexidine, Ozonated Water, and Hypochlorous Acid Solutions for Oral Care on Mucosal Integrity in Mechanically Ventilated Patients. Oral Dis. 2026 Mar 19. doi: 10.1111/odi.70245. Online ahead of print.
PubMed 41853915
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chlorhexidine Gluconate, Ozonated Water and Hypochlorous Acid Solutions Used in the Oral Care of Patients Supported by Mechanical Ventilation on the Integrity of the Oral Mucosa
- ClinicalTrials.gov ID
- NCT06942026
- Acronym / sponsor ID
- 1758-1738-28-08-2024
- Conditions
- Oral Mucosal Disorder
- Keywords
- oral care, Intensive care unit, ozonated water, Oral Mucous Membrane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 27 Apr 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 24 Apr 2025 (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.
The purpose of this clinical trial is to learn whether ozonated water and hypochlorous acid solution can restore the integrity of the oral mucosa. In addition, the investigators will learn about the safety of ozonated water and hypochlorous acid solution. The main questions that participants need to answer are:
What medical conditions do participants have while taking ozonated water and hypochlorous acid solution?
Investigators will compare ozonated water and hypochlorous acid solution with 0.12% chlorhexidine gluconate solution to see if it helps to restore the integrity of the oral mucosa.
Participants:
Participants will be asked to agree to receive oral care 4 times a day, every day for 1 week.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: Control 1Ozonated water |
| Experimental 2 | Experimental | Drug: Control 1hypochlorous acid |
| Control 1 | Active comparator | Drug: Control 1%0.12 chlorhexidine gluconate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be between the ages of 18-65,
- Have been on mechanical ventilation for at least 24 hours,
- Have no intolerance or allergy to the solutions,
- Agree to participate in the study
Key exclusion criteria (2 listed)
- Having a contraindication for oral care
- Not agreeing to participate in the study
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 |
|---|---|---|
| Control 1Also: %0.12 chlorhexidine gluconateResearchers will perform oral care with ozonated water and hypochlorous acid solution to restore oral mucous membrane integrity. | Drug | Control 1, Experimental 1, Experimental 2 |
Primary outcome
oral assessment guide
Time frame: From enrollment to the end of treatment at 1 week.
The Oral Assessment Scale will be used to assess patients' oral mucosa before oral care is provided. his scale has sections on the lips, mucosa, tongue, teeth and saliva. Each section is scored from1 to 4, and the total score is between 5 and 20. A score of 5 is assessed as normal oral mucosa, 6-10 as slight dysfunction, 11-15 as moderate dysfunction and 16-20 as severe dysfunction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 34687483Ozdemir S, Turk G. The effect of different concentrations of chlorhexidine on microbial colonization: A double-blinded randomized controlled study. Int J Nurs Pract. 2022 Apr;28(2):e13025. doi: 10.1111/ijn.13025. Epub 2021 Oct 23.
- Derived from this study: PubMed 41853915Turk G, Ozdemir S. Comparative Effects of Chlorhexidine, Ozonated Water, and Hypochlorous Acid Solutions for Oral Care on Mucosal Integrity in Mechanically Ventilated Patients. Oral Dis. 2026 Mar 19. doi: 10.1111/odi.70245. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Oral Mucosal Disorder
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Not yet recruitingObservational study
Oral Mucosal Grafting for Nasal Septal Perforation Repair
Nasal Septal Perforation
RecruitingObservational study
Biospecimen Procurement for Head and Neck Disorders
Hearing Disorder, Oral Mucosal Disease
RecruitingObservational study
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
Immunosuppression, Periodontal Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Oral Mucosal Disorder, run by Aydin Adnan Menderes 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Apr 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Sercan Özdemir (+90 256 220 29 00, sercanoz15@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral assessment guide (time frame: From enrollment to the end of treatment at 1 week.). 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 NCT06942026, which also lists 2 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 24 Apr 2025.