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IRCT20180512039625N1 IRCT 2019-01-16 Sabzevar University of Medical Sciences Comparison of effectivness of toothbrush and chlorhexidine solution and calendula officinalis extracts in preventing oral lesions Comparison of the effectivness of toothbrush and chlorhexidine solution and calendula officinalis extracts in preventing oral lesions in intubated patients 2018-06-05 anticipated 57 Complete https://irct.ir/trial/31602 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Each sample monitoring period is a week to study the effect of microbial resistance chlorhexidine solution is possible. Marigold solution is used as a mouthwash solution, Randomization description: Randomization method is simple type using a random number table, Blinding description: In order to avoid bias, the person who carries out the intervention (special care nurse with 22 years of work experience) and the evaluator are different, the assessor is blind about the type of mouthwash procedure. In this study, a statistic counselor is also required to prevent blind bias. Statisticians and counselors are involved with coding patients in this study. 3 Mouthwash and prevention of oral cavity lesions. Intervention 1: The first intervention group (toothbrush group): in case of lack of contraindication, the patient's bed head is placed at a 30-degree angle and suction of the oral cavity is performed, if necessary. In addition, the sterilized mouthwash set is opened, and all internal and external surfaces of the teeth, gums, tongue, palate, and the trachea, with the exception of lips, are cleaned with a soft toothbrush for three-four minutes. In the end, the oral cavity is washed with 0.9% normal saline solution. Intervention 2: The second intervention group (toothbrush-calendula group): in case of lack of contraindication, the patient's bed head is placed at a 30-degree angle and suction of the oral cavity is performed, if necessary. The dressing set is opened, and the oral cavity is washed with normal saline. All internal and external surfaces of the teeth, gums, tongue, palate, and the trachea, with the exception of lips, are cleaned with a soft toothbrush for three-four minutes. In the end, the oral cavity was washed with forceps and cotton impregnated with 0.2%calendula solution (five cc) for two and a half minutes. Afterwards, the oral cavity was washed with 0.9% normal saline and suctioned one more time. The oral cavity health was recorded upon admission and at the end of the fourth and seventh days. Intervention 3: Control group (toothbrush-chlorhexidine): after performing the steps of the toothbrush group, five cc of 0.2% chlorhexidine solution (Mahsa Company) is poured into the sterile receiver. Afterwards, all parts of the oral cavity are washed with forceps and a cotton ball impregnated with 0.2% chlorhexidine solution for two minutes. Following that, we wait up to 30 seconds so that the antimicrobial properties of chlorhexidine could appear. In the final stage, the oral cavity is washed with 0.9% normal saline and is then suctioned. The oral health is recorded by BOAS upon admission, as well as at the end of the fourth and seventh days. Yes - There is a plan to make this available What will be shared: - When: - To whom: - Conditions: - Where to obtain: - How to obtain: - Comments: -
public Hosein norozi bami
No. 33 , University 3, Sabzevar
Sabzevar Iran (Islamic Republic of) 9618834714 +98 51 4466 7816 norozbam@gmail.com Sabzevar University of Medical Sciences scientific Mosa Al.reza tadayonfar
Pardis Building, Tohid Blvd, Sabzevar University of Medical Sciences
Sabzevar Iran (Islamic Republic of) 9613873136 +98 51 4401 8000 mtadayonfar@medsab.ac.ir Sabzevar University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Informed consent of the legal representative The patient is Intubated during the study ( oral endotracheal tube). Having age between 18 to 65 years Have at least 20 teeth No severe shaking and ulcers in the mouth No history of hepatitis B and HIV, according to the doctor and see the test Absence of signs of aspiration According to the doctor and see no problem coagulation tests Have not doing dentures No history of allergic lesions and bleeding and periodontal disease in the mouth Lack of oral lesions and oral & maxillofacial fractures or anatomic abnormalities The absence of crowns and dentures and partial plates and other orthodontic devices Lack of grade 5 and less on the tools BOAS Lack of pregnancy and lactation in women 18 years 65 years Both Legal representative of patient dissatisfaction continued cooperation Out of the endotracheal tube Find aspiration revealed The incidence of allergic reactions Prevention Prevention Prevention The first intervention group (toothbrush group): in case of lack of contraindication, the patient's bed head is placed at a 30-degree angle and suction of the oral cavity is performed, if necessary. In addition, the sterilized mouthwash set is opened, and all internal and external surfaces of the teeth, gums, tongue, palate, and the trachea, with the exception of lips, are cleaned with a soft toothbrush for three-four minutes. In the end, the oral cavity is washed with 0.9% normal saline solution. The second intervention group (toothbrush-calendula group): in case of lack of contraindication, the patient's bed head is placed at a 30-degree angle and suction of the oral cavity is performed, if necessary. The dressing set is opened, and the oral cavity is washed with normal saline. All internal and external surfaces of the teeth, gums, tongue, palate, and the trachea, with the exception of lips, are cleaned with a soft toothbrush for three-four minutes. In the end, the oral cavity was washed with forceps and cotton impregnated with 0.2%calendula solution (five cc) for two and a half minutes. Afterwards, the oral cavity was washed with 0.9% normal saline and suctioned one more time. The oral cavity health was recorded upon admission and at the end of the fourth and seventh days. Control group (toothbrush-chlorhexidine): after performing the steps of the toothbrush group, five cc of 0.2% chlorhexidine solution (Mahsa Company) is poured into the sterile receiver. Afterwards, all parts of the oral cavity are washed with forceps and a cotton ball impregnated with 0.2% chlorhexidine solution for two minutes. Following that, we wait up to 30 seconds so that the antimicrobial properties of chlorhexidine could appear. In the final stage, the oral cavity is washed with 0.9% normal saline and is then suctioned. The oral health is recorded by BOAS upon admission, as well as at the end of the fourth and seventh days. Oral health. Timepoint: Admission, fourth and seventh day of hospitalization. Method of measurement: Beck Oral Assessment Score. Diseases of lip. Timepoint: Admission, fourth and seventh day of hospitalization. Method of measurement: Beck Oral Assessment Score. Diseases of oral mucosa. Timepoint: Beck Oral Assessment Score. Method of measurement: Admission, fourth and seventh day of hospitalization. Diseases of tongue. Timepoint: Admission, fourth and seventh day of hospitalization. Method of measurement: Beck Oral Assessment Score. Periodontal diseases. Timepoint: Admission, fourth and seventh day of hospitalization. Method of measurement: Beck Oral Assessment Score. Sabzevar University of Medical Sciences Approved 2018-05-09 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences, Pardis , Shahrak Tohid., Taleghani Blvd., 051 Sabzevar Razavi Khorasan Iran (Islamic Republic of)