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IRCT20230105057051N1 IRCT 2023-07-11 Shaheed Rajaie Cardiovascular Medical & Research Center Comparison of the effect of 0.2% chlorhexidine solution and toothbrush in the prevention of oral lesions in intubated patients hospitalized in the intensive care unit Comparison of the effect of 0.2% chlorhexidine solution and toothbrush in the prevention of oral lesions in intubated patients hospitalized in the intensive care unit 2023-07-22 anticipated 108 Complete https://irct.ir/trial/71177 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The research population includes all patients admitted to the special care department of ICU A, ICU B, CCU A, CCU B, CCU C, CCU F, CCU G, CCU P with a tracheal tube. The researcher will select the patients who meet the study entry criteria. For random allocation of people, permutation block method with size 6 will be used. Then the blocks are randomly numbered and selected and the execution method based on the permutation within the block will be done, Blinding description: The research population includes all patients admitted to the special care department of ICU A, ICU B, CCU A, CCU B, CCU C, CCU F, CCU G, CCU P with a tracheal tube. The researcher will select the patients who meet the study entry criteria. For random allocation of people, permutation block method with size 6 will be used. Then the blocks are randomly numbered and selected and the execution method based on the permutation within the block will be done. The participation of the patient will be voluntary and based on the informed consent of his legal guardian. In case of non-satisfaction, the transfer of the patient from the special care department, especially during the study period, the death of the patient during the study, the occurrence of an allergic reaction, the limitation in performing the technique, and the risk of aspiration will be excluded from the study. N/A Oral lesions. Intervention 1: Control group: Mouthwash group (group A) is performed with 0.2% chlorhexidine solution according to the routine method of the department. In this way, 10 ml of chlorhexidine is poured into a sterile receiver and the balled cotton is dipped in the chlorhexidine solution with a tweezer and the oral cavity, tongue and teeth are washed with the chlorhexidine solution. This procedure is performed at 7:00 a.m. and at 7:00 p.m. during 3 days (6 times in total) and checking with the BOAS and MPS tools is done before each mouthwash and is recorded in the relevant checklist. Intervention 2: Intervention group: In group B, using a soft toothbrush with half a centimeter of fluoride toothpaste on it, first all the internal and external surfaces of the teeth and gums with rotating movements, and then the surfaces of the tongue and palate with Back and forth movements are brushed. After brushing, the mouth is rinsed and cleaned with normal saline. This procedure is performed at 7 am and 7 pm during 3 days (6 times in total). Checking with BOAS and MPS tools is done before each brushing session and is recorded in the relevant checklist. Intervention 3: Intervention group: In group C (combined use of toothbrush and chlorhexidine mouthwash), at 7:00 a.m. and at 7:00 p.m. during 3 days (6 times in total), using a soft toothbrush and toothpaste containing fluoride, first all internal and external surfaces of the teeth and gums It is brushed with circular movements and then the surfaces of the tongue and palate are brushed with back and forth movements. After brushing, every part of the mouth is wet with normal saline, and the mouth is rinsed and cleaned with that. Then, 10 ml of chlorhexidine is poured into a sterile receiver and the balled cotton is soaked in the chlorhexidine solution with a tweezer and the mouth cavity, tongue and teeth are washed with the chlorhexidine solution. Checking with BOAS and MPS tools is done before each intervention with toothbrush and mouthwash and is recorded in the relevant checklist. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Mahnaz Shamseh
Dorna 2 Alley; Mirdamad Street; Karim Khan Zand square
Khorramabad Iran (Islamic Republic of) 6818965398 +98 66 3343 5542 mashamceh@gmail.com Shaheed Rajaie Cardiovascular medical & Research Center scientific Mahnaz Shamseh
Dorna 2 Alley;Mirdamad Street; Karim Khan Zand square
Khorramabad Iran (Islamic Republic of) 6818965398 +98 66 3343 5542 mashamceh@gmail.com Shaheed Rajaie Cardiovascular Medical & Research Center Iran (Islamic Republic of) Age above 18 years Having an oral tracheal tube for at least 3 days No wounds and severe injuries in the mouth Not having hepatitis B disease Not having HIV Not having coagulation problems Insensitivity to chlorhexidine Not having artificial teeth 18 years no limit Both Transfer of the patient from the intensive care unit during the study period Death of the patient during the study Allergic reaction Limitations in performing the technique Risk of aspiration Unwillingness to continue the study on the part of the legal guardians of the patients Perform tracheostomy during the study Endotracheal tube extubeation during the study period Prevention Prevention Prevention Control group: Mouthwash group (group A) is performed with 0.2% chlorhexidine solution according to the routine method of the department. In this way, 10 ml of chlorhexidine is poured into a sterile receiver and the balled cotton is dipped in the chlorhexidine solution with a tweezer and the oral cavity, tongue and teeth are washed with the chlorhexidine solution. This procedure is performed at 7:00 a.m. and at 7:00 p.m. during 3 days (6 times in total) and checking with the BOAS and MPS tools is done before each mouthwash and is recorded in the relevant checklist. Intervention group: In group B, using a soft toothbrush with half a centimeter of fluoride toothpaste on it, first all the internal and external surfaces of the teeth and gums with rotating movements, and then the surfaces of the tongue and palate with Back and forth movements are brushed. After brushing, the mouth is rinsed and cleaned with normal saline. This procedure is performed at 7 am and 7 pm during 3 days (6 times in total). Checking with BOAS and MPS tools is done before each brushing session and is recorded in the relevant checklist. Intervention group: In group C (combined use of toothbrush and chlorhexidine mouthwash), at 7:00 a.m. and at 7:00 p.m. during 3 days (6 times in total), using a soft toothbrush and toothpaste containing fluoride, first all internal and external surfaces of the teeth and gums It is brushed with circular movements and then the surfaces of the tongue and palate are brushed with back and forth movements. After brushing, every part of the mouth is wet with normal saline, and the mouth is rinsed and cleaned with that. Then, 10 ml of chlorhexidine is poured into a sterile receiver and the balled cotton is soaked in the chlorhexidine solution with a tweezer and the mouth cavity, tongue and teeth are washed with the chlorhexidine solution. Checking with BOAS and MPS tools is done before each intervention with toothbrush and mouthwash and is recorded in the relevant checklist. Oral hygiene method. Timepoint: It is done at 7:00 and 19:00 during 3 days (6 times in total). Method of measurement: It is checked using BOAS and MPS tools and recorded in the checklist. Oral health score. Timepoint: Intervention is done before each turn and recorded in the relevant checklist. Method of measurement: It is checked using BOAS and MPS tools and recorded in the checklist. Shaheed Rajaie Cardiovascular Medical & Research Center Approved 2023-07-09 Ethics Committee of Shaheed Rajaie Cardiovascular Medical and Research Center Vali Asr St. (AJ), next to Mellat Park, Niayesh corner Tehran Tehran Iran (Islamic Republic of)