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IRCT20191009045034N1 IRCT 2019-12-18 Shahroud University of Medical Sciences The Effectiveness of Echinacea, Listerine and Chlorhewidine mouthwashes on oral health and microbial flora. Comparing the effectiveness of Echinacea, Listerine, and chlorhexidine mouthwashes on oral microbial flora and oral health status of patients in Intensive Care Unit. 2019-10-23 anticipated 180 Complete https://irct.ir/trial/42857 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: The method of randomization is hexagonal blocking and the randomization tool is the sealed envelope. An statistic expert will accomplish the randomization sequence by using the suitable software. Sampling will be done sequentially. In order to concealment, mouthwashes are poured into same bottles and given a code, which the main researcher will not be aware, Blinding description: The outcome assessor, participants, and data analyst will not be aware of the assigned groups Participants will be unconscious Mouthwashes are poured into same bottles with different codes; which the outcome assessor will not see them. The data analyzer will also not be present in the research environment. 3 Microbial flora and oral hygiene of ICU patients. Intervention 1: Intervention group: For group A, the entire oral surface is examined with BOAS Scale and then the patient's mouth is washed with 15 cc Echinacea solution for one week and then re-examined for hygiene and colonization and then the data will be analyzed. Intervention 2: Intervention group: For group B, the entire oral surface is examined with BOAS Scale and then the patient's mouth is washed with 15 cc Listerin solution for one week and then re-examined for hygiene and colonization and then the data will be analyzed. Intervention 3: the entire oral surface is examined with BOAS Scale and then the patient's mouth is washed with 15 cc Chlorhexidine solution for one week and then re-examined for hygiene and colonization and then the data will be analyzed. Yes - There is a plan to make this available What will be shared: The obtained data after testing on 180 participants in Shohada Tajrish and Imam Hossein hospitals can be shared after unidentifiable individuals. When: Data will be accessible, 6 months after printing the results To whom: Researchers working in academies and scientific institutions, could access to data and documentation . Conditions: To promote and extend the subject under study from other aspects and to compare the results with other relevant scientific results, it is permissible to use documentation and data to improve the level of health. Where to obtain: simin_online.1988@yahoo.com How to obtain: After reviewing the reason of requesting to access documentation and data by the researcher, the data and documentation file will be sent to the researcher (one month after submitting the request). Comments:
public Simin Kakavand Araghi
Chamran Hospital, end of Sayyad shirazi highway, Tehran.Iran
Tehran Iran (Islamic Republic of) 1694613311 +98 21 2795 1190 simin_online.1988@yahoo.com Shahroud University of Medical Sciences scientific Simin Kakavandaraghi
End of sayyad shirazi highway. St sanayea. chamran hospital
Tehran Iran (Islamic Republic of) 1694613311 +98 21 2795 1190 kakavand@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) 15 to 65 years old The level of consciousness lower than 8, based on the Glasgow scale Utilizing endotracheal tube for patients’ breathing Lapsing maximum 12 hours after admitting the patient in intensive care unit 15 years 65 years Both Having active periodontal disease Having oral Traumatic or anatomic lesions in mouth Having antibiotics two weeks before hospitalization Having systemic infections Having autoimmune or malignant diseases Radio therapy prescription Utilizing immunosuppressive drugs Allergy to mouthwashes (inflation and redness in gums and oral tissue) Patients with tracheotomy Pregnancy Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: For group A, the entire oral surface is examined with BOAS Scale and then the patient's mouth is washed with 15 cc Echinacea solution for one week and then re-examined for hygiene and colonization and then the data will be analyzed Intervention group: For group B, the entire oral surface is examined with BOAS Scale and then the patient's mouth is washed with 15 cc Listerin solution for one week and then re-examined for hygiene and colonization and then the data will be analyzed the entire oral surface is examined with BOAS Scale and then the patient's mouth is washed with 15 cc Chlorhexidine solution for one week and then re-examined for hygiene and colonization and then the data will be analyzed The rate of oral microbial flora in unconscious patients. Timepoint: Prevalence of oral microbial flora in unconscious patients at baseline (before intervention) and one week after intervention. Method of measurement: Beck Oral Assessment Scale and Laboratory published reports of cultured and grown colonies. Oral health status in unconscious patients. Timepoint: Oral hygiene status in unconscious patients at baseline (before intervention) and one week after intervention. Method of measurement: Beck Oral Assessment Scale. Shahroud University of Medical Sciences Approved 2019-10-06 Ethics committee of Shahroud of Medical Sciences Shahroud University of Medical Sciences, 7th Tir Square, Shahroud, Iran Shahroud Semnan Iran (Islamic Republic of)