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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- oral assessment guide
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Having a contraindication for oral care
- •Not agreeing to participate in the study
研究组 & 干预措施
Control 1
%0.12 chlorhexidine gluconate
干预措施: Control 1 (Drug)
Experimental 1
Ozonated water
干预措施: Control 1 (Drug)
Experimental 2
hypochlorous acid
干预措施: Control 1 (Drug)
结局指标
主要结局
oral assessment guide
时间窗: 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.
次要结局
未报告次要终点
研究者
Sercan Özdemir
Principal Investigator
Aydin Adnan Menderes University