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临床试验/NCT07200297
NCT07200297招募中不适用

Comparison of Three Different Oral Care Methods in Terms of Oral Health in Intensive Care Patients Receiving Non-Invasive Mechanical Ventilation: A Randomized Controlled Trial

SÜMEYYE BİLGİLİ TEKİN2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Oral Health Status

研究概览

简要总结

This study aims to examine the effects of different oral care methods on oral health in patients receiving non-invasive mechanical ventilation (NIMV) in the intensive care unit. A randomized controlled experimental design will be employed, with three groups: Control Group - patients receiving only the standard chlorhexidine oral care kit; Electric Toothbrush Group - patients receiving the chlorhexidine kit in combination with an electric toothbrush and toothpaste; and Manual Toothbrush Group - patients receiving the chlorhexidine kit along with a manual toothbrush and toothpaste. Data collection tools will include the Patient Demographic Information Form, Oral Assessment Guide, saliva pH measurement, and salivation assessment using the Schirmer Tear Test Strip. The study is designed to compare the effects of different oral care methods on the oral health of patients receiving NIMV and to identify the most effective method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be in an intensive care unit
  • Must have consented to participate in the study from themselves or their family
  • Must be over 18 years of age
  • Must be on a non-invasive mechanical ventilator
  • Must have no known active infection.
  • Must be in a stable state of consciousness and able to communicate.
  • Must be expected to remain in intensive care for at least 48 hours.

排除标准

  • Intubated patients.
  • Patients with severe oral infections or bleeding mucosal wounds.
  • Those receiving radiotherapy/chemotherapy to the head and neck region.
  • Organ transplant patients.
  • Patients without oral anatomic abnormalities or dentures.
  • Those who refused to participate in the study or did not sign the consent form.
  • Patients with chronic or acute health conditions that prevent oral hygiene.

结局指标

主要结局

Oral Health Status

时间窗: From day 1 to day 3 (3 consecutive days).

Oral health will be assessed using the Oral Assessment Guide (OAG). The guide examines eight areas (voice, swallowing, lips, tongue, saliva, mucous membranes, gums, and teeth/dentures). Each item is scored from 1 (healthy) to 3 (severely impaired). The total score ranges from 8-24. Scale score (8-24). A low score indicates good oral health, while a high score indicates deterioration in oral health.

次要结局

  • Saliva pH Value(From day 1 to day 3 (3 consecutive days).)

研究者

发起方
SÜMEYYE BİLGİLİ TEKİN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

SÜMEYYE BİLGİLİ TEKİN

Nursing Fundamentals Graduate Student

Ataturk University

研究点 (2)

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