Oral ComplicationsNCT05039593
Oral Care Frequency in Mechanically Ventilated Patients
A study testing chlorhexidine in people with Oral Complications, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Many problems may develop in patients due to mechanical ventilation in intensive care units. These include ventilator-associated pneumonia, decreased cerebral perfusion, venous air embolism, sinus and eye infections, neuromuscular dysfunctions and skin sores may be seen in intensive care patients undergoing mechanical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Complications
- What is being tested?
- chlorhexidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2021to 1 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- who are over 18 years old,
- In the first 24 hours of mechanical ventilation,
- It will consist of patients with consent from their relatives.
Who cannot join
- Surgery for the mouth,
- Patients with oral aphthae, stomatitis, candiasis, gingivitis will not be taken.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University
Aydin, Efeler, 09100
About this study
Official title: The Effect of Oral Care Frequency on Oral Mucosa Membrane Integrity in Patients With Mechanical Ventilation Support
Many problems may develop in patients due to mechanical ventilation in intensive care units. These include ventilator-associated pneumonia, decreased cerebral perfusion, venous air embolism, sinus and eye infections, neuromuscular dysfunctions and skin sores may be seen in intensive care patients undergoing mechanical ventilation. If adequate oral hygiene is not provided in patients on mechanical ventilation support, dry mouth, halitosis, disruption of tissue integrity in and around the mouth, intraoral infections and periodontal diseases may occur. Most importantly, ventilator-associated pneumonia (VIP) may develop in patients dependent on mechanical ventilation due to deficient oral care.
Chlorhexidine solution is widely used in oral care. However, there is a need for evidence about the frequency of oral care with which chlorhexidine solution on oral mucous membrane integrity in patients under mechanical ventilation support. Oral care frequency was not examined in these existing studies. Therefore, this study was planned to determine the effect of three different oral care frequencies on the integrity of the oral mucous membrane in patients connected to mechanical ventilators.
Read the detailed description
Oral hygiene is one of the applications where the individual needs the most hygienic care. Providing oral care and maintaining oral hygiene improves the comfort and quality of life by ensuring that the individual eats healthy and feels well.Inadequate oral care can negatively affect all these, as well as cause problems such as dry mouth, dental caries, periodontal diseases, bad breath and stomatitis.Therefore, in order to maintain oral health, individuals must perform oral care effectively.
Nurses need to have adequate oral intake to maintain the integrity of the oral mucosa, especially in patients who cannot be fed orally, with fluid restriction, administered nasogastric tube, mouth breathing, receiving oxygen therapy, undergoing oral and maxillofacial surgery, undergoing radiation therapy, chemotherapy, in the terminal period, in coma, and in patients dependent on mechanical ventilator. care must be provided.
Defense mechanisms in intensive care patients are affected by their disease and multiple interventions that circumvent natural host defenses. Treatments applied in intensive care units, lack of fluid intake of the patient, and some materials used for treatment and care cause changes in the oral mucous membrane. Inadequate protective mechanisms in patients can lead to both local and systemic complications such as caries, periodontal disease, oral mucosal infections, and ventilator-associated pneumonia.
Bacterial oropharyngeal colonization progressively changes to tracheal colonization leading to ventilator-associated pneumonia.
Especially in patients connected to mechanical ventilators, the entry of bacteria into the respiratory tract is facilitated and increased due to the endotracheal tube, causing the coughing reflex and mucociliar activity to be impaired and secretion to increase. In this case, gram-positive bacteria that make up the normal flora in the oral mucosa are replaced by gram-negative bacteria, causing changes in the oral flora and plaque formation on the teeth. Therefore, oral care becomes much more important.The solution and frequency to be used gain importance for oral care to be effective on the integrity of the oral mucous membrane.
In the literature, it is recommended to use chlorhexidine gluconate solution in oral care to prevent the development of ventilator-associated pneumonia in mechanically ventilated patients.However, there is no evidence on how often oral care should be performed.
When the literature is reviewed, further studies with conclusive evidence to show how often chlorhexidine gluconate is effective are needed. For this reason, this study was planned to determine the effect of three different oral care frequencies on the integrity of the oral mucous membrane in patients dependent on mechanical ventilators.
The research is planned to be carried out between 01.06.2021 and 01.06.2022 in the internal medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital.
The population of the research is the patients hospitalized in the Internal Medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital between 01.06.2021 and 01.06.2022, and the sample is; Patients who are older than 18 years of age, who are in the first 24 hours of mechanical ventilation, who are 18 years of age and older, and whose relatives have consented. The sample of the research; Patients with thrombocytopenia, leukopenia and oral aphthae, stomatitis, candiasis, gingivitis who have had an oral surgical procedure will not be accepted.
Before starting the practice in this study, the purpose of the research will be explained to all nurses working in the unit by the researchers and an information meeting about oral care will be held. After the operability of the guide in the intensive care unit is ensured, the data collection phase will begin. Randomization of patients will be done by the nurse in charge of the service.
The frequency of oral care of the patients will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses. In oral care, 0.12% chlorhexidine solution will be used.
The concentration of 0.12% of the chlorhexidine gluconate solution planned to be used in the research is the most frequently used form compared to the other concentrations of the solution. And no side effects were noted in the studies.
For this reason, 0.12% chlorhexidine solution was preferred. When the literature is examined, this density was preferred because it is the most frequently used solution in the oral care of patients under mechanical ventilation support.
The oral mucosa of the patients will be evaluated with the Oral Evaluation Scale by the researcher before the first oral care application every morning for four days. According to the score obtained from the scale, the researcher will evaluate the patients as normal oral mucosa, mild dysfunction, moderate dysfunction and severe dysfunction.
- Conditions
- Oral Complications
- Being tested
- chlorhexidine
- Keywords
- Oral care, Chlorhexidine, Mechanical Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidineOther
The population of the research is the patients hospitalized in the Internal Medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital between 01.06.2021 and 01.06.2022, and the sample is; Patients who are older than 18 years of age, who are in the first 24 hours of mechanical ventilation, who are 18 years of age and older, and whose relatives have consented.Oral care of the patients will be done with 0.12% chlorhexidine solution, and the frequency of oral care will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses.
| Study group | Role | What they receive |
|---|---|---|
| first group | Experimental | The patients in the first group will be given oral care with 0.12% chlorhexidine twice a day. Receives: Other: chlorhexidine |
| second group | Experimental | The patients in the second group will be given oral care with 0.12% chlorhexidine 3 times a day. Receives: Other: chlorhexidine |
| third group | Experimental | The patients in the third group will be given oral care with 0.12% chlorhexidine 4 times a day. Receives: Other: chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral mucosal evaluation of patients.
The oral mucosa of the patients will be evaluated with the Eilers Mouth Rating Scale.
Measured: Oral care is given to patient groups 2 times a day, 3 times a day, 4 times a day for 4 days. Evaluation will be done at the beginning of the study and every day for 4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start5 Jul 2021
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Oral ComplicationsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Before starting the practice in this study, the purpose of the research will be explained to all nurses working in the unit by the researchers and an information meeting about oral care will be held. After the operability of the guide in the intensive care unit is ensured, the data collection phase will begin. Randomization of patients will be done by the nurse in charge of the service. The frequency of oral care of the patients will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses.
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslıhan Tahtali Turgut, Aydin Adnan Menderes University
- Investigators
- Gülengün Türk, Prof.Dr, Study director, Aydın Adnan Menderes University, Faculty of Nursing, Department of Nursing Fundamentals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039593
- Sponsor's protocol ID
- Oral Care Frequency
- Status last verified
- Jul 2022
- First submitted
- 2 Jul 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
La Combe B, Maherault AC, Messika J, Billard-Pomares T, Branger C, Landraud L, Dreyfuss D, Dib F, Massias L, Ricard JD. Oropharyngeal Bacterial Colonization after Chlorhexidine Mouthwash in Mechanically Ventilated Critically Ill Patients. Anesthesiology. 2018 Dec;129(6):1140-1148. doi: 10.1097/ALN.0000000000002451.
PubMed 30247201Villar CC, Pannuti CM, Nery DM, Morillo CM, Carmona MJ, Romito GA. Effectiveness of Intraoral Chlorhexidine Protocols in the Prevention of Ventilator-Associated Pneumonia: Meta-Analysis and Systematic Review. Respir Care. 2016 Sep;61(9):1245-59. doi: 10.4187/respcare.04610. Epub 2016 Aug 9.
PubMed 27507174Deschepper M, Waegeman W, Eeckloo K, Vogelaers D, Blot S. Effects of chlorhexidine gluconate oral care on hospital mortality: a hospital-wide, observational cohort study. Intensive Care Med. 2018 Jul;44(7):1017-1026. doi: 10.1007/s00134-018-5171-3. Epub 2018 May 9.
PubMed 29744564Kocacal Guler E, Turk G. Oral Chlorhexidine Against Ventilator-Associated Pneumonia and Microbial Colonization in Intensive Care Patients. West J Nurs Res. 2019 Jun;41(6):901-919. doi: 10.1177/0193945918781531. Epub 2018 Jun 15.
PubMed 29907077Haghighi A, Shafipour V, Bagheri-Nesami M, Gholipour Baradari A, Yazdani Charati J. The impact of oral care on oral health status and prevention of ventilator-associated pneumonia in critically ill patients. Aust Crit Care. 2017 Mar;30(2):69-73. doi: 10.1016/j.aucc.2016.07.002. Epub 2016 Aug 4.
PubMed 27499527Houston S, Hougland P, Anderson JJ, LaRocco M, Kennedy V, Gentry LO. Effectiveness of 0.12% chlorhexidine gluconate oral rinse in reducing prevalence of nosocomial pneumonia in patients undergoing heart surgery. Am J Crit Care. 2002 Nov;11(6):567-70.
PubMed 12425407Lee S, Lighvan NL, McCredie V, Pechlivanoglou P, Krahn M, Quinonez C, Azarpazhooh A. Chlorhexidine-Related Mortality Rate in Critically Ill Subjects in Intensive Care Units: A Systematic Review and Meta-Analysis. Respir Care. 2019 Mar;64(3):337-349. doi: 10.4187/respcare.06434.
PubMed 30850551McCue MK, Palmer GA. Use of Chlorhexidine to Prevent Ventilator-Associated Pneumonia in a Long-term Care Setting: A Retrospective Medical Record Review. J Nurs Care Qual. 2019 Jul/Sep;34(3):263-268. doi: 10.1097/NCQ.0000000000000367.
PubMed 30325851Ory J, Raybaud E, Chabanne R, Cosserant B, Faure JS, Guerin R, Calvet L, Pereira B, Mourgues C, Guelon D, Traore O. Comparative study of 2 oral care protocols in intensive care units. Am J Infect Control. 2017 Mar 1;45(3):245-250. doi: 10.1016/j.ajic.2016.09.006. Epub 2016 Oct 27.
PubMed 28341071Saddki N, Mohamad Sani FE, Tin-Oo MM. Oral care for intubated patients: a survey of intensive care unit nurses. Nurs Crit Care. 2017 Mar;22(2):89-98. doi: 10.1111/nicc.12119. Epub 2014 Oct 28.
PubMed 25349099Turk G, Kocacal Guler E, Eser I, Khorshid L. Oral care practices of intensive care nurses: a descriptive study. Int J Nurs Pract. 2012 Aug;18(4):347-53. doi: 10.1111/j.1440-172X.2012.02045.x.
PubMed 22845634Zand F, Zahed L, Mansouri P, Dehghanrad F, Bahrani M, Ghorbani M. The effects of oral rinse with 0.2% and 2% chlorhexidine on oropharyngeal colonization and ventilator associated pneumonia in adults' intensive care units. J Crit Care. 2017 Aug;40:318-322. doi: 10.1016/j.jcrc.2017.02.029. Epub 2017 Mar 1.
PubMed 28320561Bordenave C. [Evaluation of the effectiveness of a protocol of intensification of mouth care (teeth brushing and chlorhexidine 0.12%) on the colonisation of tracheal aspirations in intubated and ventilated patients in intensive care]. Rech Soins Infirm. 2011 Sep;(106):92-8. French.
PubMed 21972580
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Care Frequency on Oral Mucosa Membrane Integrity in Patients With Mechanical Ventilation Support
- ClinicalTrials.gov ID
- NCT05039593
- Acronym / sponsor ID
- Oral Care Frequency
- Conditions
- Oral Complications
- Keywords
- Oral care, Chlorhexidine, Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 9 Sep 2021 (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.
Many problems may develop in patients due to mechanical ventilation in intensive care units. These include ventilator-associated pneumonia, decreased cerebral perfusion, venous air embolism, sinus and eye infections, neuromuscular dysfunctions and skin sores may be seen in intensive care patients undergoing mechanical ventilation. If adequate oral hygiene is not provided in patients on mechanical ventilation support, dry mouth, halitosis, disruption of tissue integrity in and around the mouth, intraoral infections and periodontal diseases may occur. Most importantly, ventilator-associated pneumonia (VIP) may develop in patients dependent on mechanical ventilation due to deficient oral care.
Chlorhexidine solution is widely used in oral care. However, there is a need for evidence about the frequency of oral care with which chlorhexidine solution on oral mucous membrane integrity in patients under mechanical ventilation support. Oral care frequency was not examined in these existing studies. Therefore, this study was planned to determine the effect of three different oral care frequencies on the integrity of the oral mucous membrane in patients connected to mechanical ventilators.
Detailed description
Oral hygiene is one of the applications where the individual needs the most hygienic care. Providing oral care and maintaining oral hygiene improves the comfort and quality of life by ensuring that the individual eats healthy and feels well.Inadequate oral care can negatively affect all these, as well as cause problems such as dry mouth, dental caries, periodontal diseases, bad breath and stomatitis.Therefore, in order to maintain oral health, individuals must perform oral care effectively.
Nurses need to have adequate oral intake to maintain the integrity of the oral mucosa, especially in patients who cannot be fed orally, with fluid restriction, administered nasogastric tube, mouth breathing, receiving oxygen therapy, undergoing oral and maxillofacial surgery, undergoing radiation therapy, chemotherapy, in the terminal period, in coma, and in patients dependent on mechanical ventilator. care must be provided.
Defense mechanisms in intensive care patients are affected by their disease and multiple interventions that circumvent natural host defenses. Treatments applied in intensive care units, lack of fluid intake of the patient, and some materials used for treatment and care cause changes in the oral mucous membrane. Inadequate protective mechanisms in patients can lead to both local and systemic complications such as caries, periodontal disease, oral mucosal infections, and ventilator-associated pneumonia.
Bacterial oropharyngeal colonization progressively changes to tracheal colonization leading to ventilator-associated pneumonia.
Especially in patients connected to mechanical ventilators, the entry of bacteria into the respiratory tract is facilitated and increased due to the endotracheal tube, causing the coughing reflex and mucociliar activity to be impaired and secretion to increase. In this case, gram-positive bacteria that make up the normal flora in the oral mucosa are replaced by gram-negative bacteria, causing changes in the oral flora and plaque formation on the teeth. Therefore, oral care becomes much more important.The solution and frequency to be used gain importance for oral care to be effective on the integrity of the oral mucous membrane.
In the literature, it is recommended to use chlorhexidine gluconate solution in oral care to prevent the development of ventilator-associated pneumonia in mechanically ventilated patients.However, there is no evidence on how often oral care should be performed.
When the literature is reviewed, further studies with conclusive evidence to show how often chlorhexidine gluconate is effective are needed. For this reason, this study was planned to determine the effect of three different oral care frequencies on the integrity of the oral mucous membrane in patients dependent on mechanical ventilators.
The research is planned to be carried out between 01.06.2021 and 01.06.2022 in the internal medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital.
The population of the research is the patients hospitalized in the Internal Medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital between 01.06.2021 and 01.06.2022, and the sample is; Patients who are older than 18 years of age, who are in the first 24 hours of mechanical ventilation, who are 18 years of age and older, and whose relatives have consented. The sample of the research; Patients with thrombocytopenia, leukopenia and oral aphthae, stomatitis, candiasis, gingivitis who have had an oral surgical procedure will not be accepted.
Before starting the practice in this study, the purpose of the research will be explained to all nurses working in the unit by the researchers and an information meeting about oral care will be held. After the operability of the guide in the intensive care unit is ensured, the data collection phase will begin. Randomization of patients will be done by the nurse in charge of the service.
The frequency of oral care of the patients will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses. In oral care, 0.12% chlorhexidine solution will be used.
The concentration of 0.12% of the chlorhexidine gluconate solution planned to be used in the research is the most frequently used form compared to the other concentrations of the solution. And no side effects were noted in the studies.
For this reason, 0.12% chlorhexidine solution was preferred. When the literature is examined, this density was preferred because it is the most frequently used solution in the oral care of patients under mechanical ventilation support.
The oral mucosa of the patients will be evaluated with the Oral Evaluation Scale by the researcher before the first oral care application every morning for four days. According to the score obtained from the scale, the researcher will evaluate the patients as normal oral mucosa, mild dysfunction, moderate dysfunction and severe dysfunction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Before starting the practice in this study, the purpose of the research will be explained to all nurses working in the unit by the researchers and an information meeting about oral care will be held. After the operability of the guide in the intensive care unit is ensured, the data collection phase will begin. Randomization of patients will be done by the nurse in charge of the service. The frequency of oral care of the patients will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses.
| Arm | Type | Receives |
|---|---|---|
| first group | Experimental | Other: chlorhexidineThe patients in the first group will be given oral care with 0.12% chlorhexidine twice a day. |
| second group | Experimental | Other: chlorhexidineThe patients in the second group will be given oral care with 0.12% chlorhexidine 3 times a day. |
| third group | Experimental | Other: chlorhexidineThe patients in the third group will be given oral care with 0.12% chlorhexidine 4 times a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- who are over 18 years old,
- In the first 24 hours of mechanical ventilation,
- It will consist of patients with consent from their relatives.
Key exclusion criteria (2 listed)
- Surgery for the mouth,
- Patients with oral aphthae, stomatitis, candiasis, gingivitis will not be taken.
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 |
|---|---|---|
| chlorhexidineThe population of the research is the patients hospitalized in the Internal Medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital between 01.06.2021 and 01.06.2022, and the sample is; Patients who are older than 18 years of age, who are in the first 24 hours of mechanical ventilation, who are 18 years of age and older, and whose relatives have consented.Oral care of the patients will be done with 0.12% chlorhexidine solution, and the frequency of oral care will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses. | Other | first group, second group, third group |
Primary outcome
Oral mucosal evaluation of patients.
Time frame: Oral care is given to patient groups 2 times a day, 3 times a day, 4 times a day for 4 days. Evaluation will be done at the beginning of the study and every day for 4 days.
The oral mucosa of the patients will be evaluated with the Eilers Mouth Rating Scale.
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 20 Jul 2022.
- Background: PubMed 30247201La Combe B, Maherault AC, Messika J, Billard-Pomares T, Branger C, Landraud L, Dreyfuss D, Dib F, Massias L, Ricard JD. Oropharyngeal Bacterial Colonization after Chlorhexidine Mouthwash in Mechanically Ventilated Critically Ill Patients. Anesthesiology. 2018 Dec;129(6):1140-1148. doi: 10.1097/ALN.0000000000002451.
- Background: PubMed 27507174Villar CC, Pannuti CM, Nery DM, Morillo CM, Carmona MJ, Romito GA. Effectiveness of Intraoral Chlorhexidine Protocols in the Prevention of Ventilator-Associated Pneumonia: Meta-Analysis and Systematic Review. Respir Care. 2016 Sep;61(9):1245-59. doi: 10.4187/respcare.04610. Epub 2016 Aug 9.
- Background: PubMed 29744564Deschepper M, Waegeman W, Eeckloo K, Vogelaers D, Blot S. Effects of chlorhexidine gluconate oral care on hospital mortality: a hospital-wide, observational cohort study. Intensive Care Med. 2018 Jul;44(7):1017-1026. doi: 10.1007/s00134-018-5171-3. Epub 2018 May 9.
- Background: PubMed 29907077Kocacal Guler E, Turk G. Oral Chlorhexidine Against Ventilator-Associated Pneumonia and Microbial Colonization in Intensive Care Patients. West J Nurs Res. 2019 Jun;41(6):901-919. doi: 10.1177/0193945918781531. Epub 2018 Jun 15.
- Background: PubMed 27499527Haghighi A, Shafipour V, Bagheri-Nesami M, Gholipour Baradari A, Yazdani Charati J. The impact of oral care on oral health status and prevention of ventilator-associated pneumonia in critically ill patients. Aust Crit Care. 2017 Mar;30(2):69-73. doi: 10.1016/j.aucc.2016.07.002. Epub 2016 Aug 4.
- Background: PubMed 12425407Houston S, Hougland P, Anderson JJ, LaRocco M, Kennedy V, Gentry LO. Effectiveness of 0.12% chlorhexidine gluconate oral rinse in reducing prevalence of nosocomial pneumonia in patients undergoing heart surgery. Am J Crit Care. 2002 Nov;11(6):567-70.
- Background: PubMed 30850551Lee S, Lighvan NL, McCredie V, Pechlivanoglou P, Krahn M, Quinonez C, Azarpazhooh A. Chlorhexidine-Related Mortality Rate in Critically Ill Subjects in Intensive Care Units: A Systematic Review and Meta-Analysis. Respir Care. 2019 Mar;64(3):337-349. doi: 10.4187/respcare.06434.
- Background: PubMed 30325851McCue MK, Palmer GA. Use of Chlorhexidine to Prevent Ventilator-Associated Pneumonia in a Long-term Care Setting: A Retrospective Medical Record Review. J Nurs Care Qual. 2019 Jul/Sep;34(3):263-268. doi: 10.1097/NCQ.0000000000000367.
- Background: PubMed 28341071Ory J, Raybaud E, Chabanne R, Cosserant B, Faure JS, Guerin R, Calvet L, Pereira B, Mourgues C, Guelon D, Traore O. Comparative study of 2 oral care protocols in intensive care units. Am J Infect Control. 2017 Mar 1;45(3):245-250. doi: 10.1016/j.ajic.2016.09.006. Epub 2016 Oct 27.
- Background: PubMed 25349099Saddki N, Mohamad Sani FE, Tin-Oo MM. Oral care for intubated patients: a survey of intensive care unit nurses. Nurs Crit Care. 2017 Mar;22(2):89-98. doi: 10.1111/nicc.12119. Epub 2014 Oct 28.
- Background: PubMed 22845634Turk G, Kocacal Guler E, Eser I, Khorshid L. Oral care practices of intensive care nurses: a descriptive study. Int J Nurs Pract. 2012 Aug;18(4):347-53. doi: 10.1111/j.1440-172X.2012.02045.x.
- Background: PubMed 28320561Zand F, Zahed L, Mansouri P, Dehghanrad F, Bahrani M, Ghorbani M. The effects of oral rinse with 0.2% and 2% chlorhexidine on oropharyngeal colonization and ventilator associated pneumonia in adults' intensive care units. J Crit Care. 2017 Aug;40:318-322. doi: 10.1016/j.jcrc.2017.02.029. Epub 2017 Mar 1.
- Individual participant dataSharing planned: No
Related trials for Oral Complications
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
RecruitingPhase 3
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
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.
Gülengün Türk, Prof.Dr study director
Aydın Adnan Menderes University, Faculty of Nursing, Department of Nursing Fundamentals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chlorhexidine in people with Oral Complications, 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 3 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: finished, as of the sponsor's last update on 20 Jul 2022. 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?
Oral mucosal evaluation of patients. (time frame: Oral care is given to patient groups 2 times a day, 3 times a day, 4 times a day for 4 days. Evaluation will be done at the beginning of the study and every day for 4 days.). 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 NCT05039593, which also lists 13 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 20 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.