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IRCT20230513058170N1 IRCT 2023-06-20 Zahedan University of Medical Sciences Investigating the effect of pomegranate skin mouthwash on oral hygiene and bacterial colonization of oral and tracheal intubated patients admitted to the intensive care units(ICUs) Investigating the effect of pomegranate skin mouthwash on oral hygiene and bacterial colonization of oral and tracheal intubated patients admitted to the intensive care units(ICUs) 2023-05-22 anticipated 80 Complete https://irct.ir/trial/70132 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling is based on the entry criteria and is selected in an available manner, and then the random number table will be used for the random allocation of patients in such a way that for each person from the sample, a point will be determined on the random number table using a pen tip, and then We move from right to left and a number will be selected from the table of random numbers. If even and zero digits are obtained, the person will be in the intervention group, and if odd numbers are obtained, the person will be placed in the control group, Blinding description: Single-blind clinical trial - in such a way that blinding will be done for the laboratory expert , for this purpose, the samples collected by the researcher will be provided to the laboratory in the same containers with the same label and code, and the laboratory official will not be aware of the type of intervention. 1-2 Investigating the effect of pomegranate peel extract mouthwash on oral hygiene. Intervention 1: The intervention group-preparation of pomegranate peel extract from Adonisgol Daru Company-Tehran, has an international approval and certificate. Pomegranate peel extract with a concentration of 0.2% is administered twice a day at an interval of 12 hours (9-21) for four days, before the intervention. The entire surface of the mouth, gums, tongue, pharynx, and tooth surfaces is carefully brushed with a soft children'stoothbrush, and the remaining secretions in the throat and mouth are suctioned with a sterile green Nalaton catheter in less than 30 seconds. . The whole process of cleaning the mouth and washing takes 6 minutes. Intervention 2: Control group: chlorhexidine mouthwash 0.2% - according to the routine of the ICU department using 0.2% chlorhexidine mouthwash, which is done twice a day every 12 hours (9-21) for four days, before the intervention. The entire surface of the mouth, gums, tongue, pharynx, and tooth surfaces is carefully brushed with a soft children'stoothbrush, and the remaining secretions in the throat and mouth are suctioned with a sterile green Nalaton catheter in less than 30 seconds. . The whole process of cleaning the mouth and washing takes 6 minutes. 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 Marzieh Saravani Pak
No.34 JamJamStreet62 ThreeAlley
Zahedan Iran (Islamic Republic of) 9814745413 +98 54 3328 9758 msaravanipak@gmail.com Zahedan University of Medical Sciences scientific Dr. Mehdi Rizvani Amin
Behdasht Street-Mashahir Bivd-School of Nursing and Midwifery
Zahedan Iran (Islamic Republic of) 05433442481 +98 54 3344 2481 Mehdi.rezvaniamin@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Intubated patients admitted to the special care department of teaching hospitals in Zahedan - Patients with a tracheal tube and a level of consciousness of 3 to 7 on the GCS scale 2- Age 18 to 65 years 3- 24 hours have passed since the admission or hospitalization of the patient 4- Having natural teeth in the patient 5- Not having a history of allergy to pomegranate 6- Absence of a specific lesion in the mouth 7- The patient should not have radiotherapy experience 8- Willingness of the patient's legal guardian to continue participating in the study 9- Obtaining oral health evaluation checklist score less than 16. 18 years 65 years Both - Airway damage during intubation 2- Pneumonia as an inpatient diagnosis 3- History of allergy to used mouthwash, asthma, allergic rhinitis and skin inflammation 4- Signs of sensitivity to mouthwash, such as redness, urticaria, and sores inside the mouth 5- Transfer of the patient from ICU or his death before the completion of the research Prevention Prevention The intervention group-preparation of pomegranate peel extract from Adonisgol Daru Company-Tehran, has an international approval and certificate. Pomegranate peel extract with a concentration of 0.2% is administered twice a day at an interval of 12 hours (9-21) for four days, before the intervention. The entire surface of the mouth, gums, tongue, pharynx, and tooth surfaces is carefully brushed with a soft children'stoothbrush, and the remaining secretions in the throat and mouth are suctioned with a sterile green Nalaton catheter in less than 30 seconds. . The whole process of cleaning the mouth and washing takes 6 minutes. Control group: chlorhexidine mouthwash 0.2% - according to the routine of the ICU department using 0.2% chlorhexidine mouthwash, which is done twice a day every 12 hours (9-21) for four days, before the intervention. The entire surface of the mouth, gums, tongue, pharynx, and tooth surfaces is carefully brushed with a soft children'stoothbrush, and the remaining secretions in the throat and mouth are suctioned with a sterile green Nalaton catheter in less than 30 seconds. . The whole process of cleaning the mouth and washing takes 6 minutes. The bacterial colonization status of the tracheal tube of intubated patients. Timepoint: on the first day (before admission of patients) and on the fourth day in the ICU department. Method of measurement: Beck's measurement scale - oral mucosal plaque score - culture from Score obtained from the scale (MPS) = 2-4 a unacceptable MPS = 7-8 weak, the score received every day on the scale (BOAS). Number 5 no disorder, 6-10 mild disorder, 11-15 moderate disorder, 16-20 severe disordeĜŒCultivation on the first day (before admission of patients) and the fourth day in the ICU departmentmouth and tracheal tube. Zahedan University of Medical Sciences Approved 2023-05-14 Ethics Committee of Zahedan University of Medical Sciences Zahedan, 62 Jam Jam St., Milan II, on the right side of the third door Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)