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IRCT20190714044197N1 IRCT 2019-08-04 Birjand University of Medical Sciences The effect of different mouthwashes on oral hygiene of patients using ventilator Comparing the efficacy of Matricaria chamomilla, Achillea millefolium, and chlorhexidine gluconate mouthwashes on dental plaque and oral mucosal lesions of patients using ventilator in the intensive care unit 2019-07-23 anticipated 75 Complete https://irct.ir/trial/40770 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Samples will be recruited via convenience sampling method and allocated to study groups via permuted block randomization, Blinding description: In this study, patients and their companions will be aware of the overall study design but will not be aware of the type of intervention the patient is to receive. Mouthwash solutions will be delivered to the nurses participating in the study in similar containers labeled A, B, or C, and the nurses will not be aware of the solution in the containers. Moreover, the statistical analyzer will not be informed of the interventions. 2-3 Condition 1: oral mucosal lesions. Condition 2: dental plaque. Intervention 1: Intervention group 1 (Matricaria chamomilla): Matricaria chamomilla extract at a concentration of 10 percent (made by Adonis Gol Darou Company) will be administered three times daily with a volume of 10 milliliters for 5 days. Intervention 2: Intervention group 2 (Achillea millefolium): Achillea millefolium extract at a concentration of 5 percent (made by Adonis Gol Darou Company) will be administered three times daily with a volume of 10 milliliters for 5 days. Intervention 3: Control group (Chlorhexidine gluconate): The control group patients will use 0.2 percent chlorhexidine gluconate mouthwash three times daily with a volume of 10 milliliters for 5 days. Yes - There is a plan to make this available What will be shared: Deidentified Individual Participant Data Set When: after the paper extracted from the research project is published and for six months To whom: paper readers Conditions: for research purposes Where to obtain: personal correspondence with the corresponding author of the paper How to obtain: email Comments:
public Fatemeh Sabzeh Kar
Ghafari St
Birjand Iran (Islamic Republic of) 9717936643 +98 56 3245 4252 fsabzehkar@bums.ac.ir Birjand University of Medical Sciences scientific Marzieh Mogharab
Ghafari St.
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3239 5632 marziehmogharab@yahoo.com Birjand University of Medical Sciences Iran (Islamic Republic of) Informed consent provided by the patient or guardian for participation Age between 15 and 65 years Less than 6 hours passed from the patient's admission in the intensive care unit Having an oral tube Having at least 12 natural teeth and not having more than 6 dentures 15 years 65 years Both Diabetes Immune system disorders Traumatic oral injuries Taking anti-coagulant drugs K13.70 K02.9 Unspecified lesions of oral mucosa Dental caries, unspecified Prevention Prevention Prevention Intervention group 1 (Matricaria chamomilla): Matricaria chamomilla extract at a concentration of 10 percent (made by Adonis Gol Darou Company) will be administered three times daily with a volume of 10 milliliters for 5 days. Intervention group 2 (Achillea millefolium): Achillea millefolium extract at a concentration of 5 percent (made by Adonis Gol Darou Company) will be administered three times daily with a volume of 10 milliliters for 5 days. Control group (Chlorhexidine gluconate): The control group patients will use 0.2 percent chlorhexidine gluconate mouthwash three times daily with a volume of 10 milliliters for 5 days. Oral mucosal lesions. Timepoint: Before the intervention, the second and fifth days after the intervention. Method of measurement: Beck Oral Assessment Scale. Dental plaque. Timepoint: Before the intervention, the second and fifth days after the intervention. Method of measurement: Mucosal-plaque score index. Birjand University of Medical Sciences Approved 2019-07-09 Ethics Committee of Birjand University of Medical Sciences Ghaffari Street Birjand South Khorasan Iran (Islamic Republic of)