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

NCT06942026 | Not Yet Recruiting Phase 4

• 1 other identifier: 1758-1738-28-08-2024
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Oral Mucosal Disorder

Keywords

oral care; Intensive care unit; ozonated water; Oral Mucous Membrane

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 1 week.

Study Arms (3)

Experimental 1

EXPERIMENTAL

Ozonated water

Drug: Control 1

Experimental 2

EXPERIMENTAL

hypochlorous acid

Drug: Control 1

Control 1

ACTIVE COMPARATOR

%0.12 chlorhexidine gluconate

Drug: Control 1

Interventions

Control 1 DRUG

Researchers will perform oral care with ozonated water and hypochlorous acid solution to restore oral mucous membrane integrity.

Also known as: %0.12 chlorhexidine gluconate

Control 1; Experimental 1; Experimental 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Having a contraindication for oral care
• Not agreeing to participate in the study

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes Univercity

Aydin, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34687483 BACKGROUND

Central Study Contacts

Sercan Özdemir

CONTACT

+90 256 220 29 00; sercanoz15@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 24, 2025
• Study Start: April 27, 2025
• Primary Completion: May 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

TU (1)