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IRCT2017082635906N1 IRCT 2017-09-09 The Vice-Chancellor of Research of Bushehr University of Medical Sciences Study of analgesic and anti-inflammatory effect of ginger Comparison of analgesic and anti-inflammatory effect of topical application of ginger aqueous extract with local dexamethasone injection after extraction of mandibular wisdom teeth 2017-09-06 anticipated 50 Complete https://irct.ir/trial/26998 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. N/A Extracting the mandibular double-sided wisdom teeth. In this double-blind clinical trial, anti-inflammatory and anti-inflammatory effects of topical administration of a 20% tissue bioadhesive made of 100% ginger extract and a mucosal dexamethasone injection of 1.6 mg after extraction of the wisdom teeth will be compared. The similarity of the mandibular teeth is performed by a qualified expert oral and maxillofacial radiologist through panoramic radiography images based on the indications in the radiology images and the classifications available in reference books as well as by a clinical examination by a oral and maxillofacial surgeon. The angle of tooth placement in the jaw, the amount of bone and soft tissue on the tooth, and the tooth position should be similar. Each patient will take amoxicillin 500 mg and metronidazole 400 mg 30 minutes before startingextraction. For each patient, the choice of which treatment is to be done on his right or left tooth will be done using random numbers. Patients will be injected with two carpool of lidocaine anesthetics with inferior alveolar nrve block technique, then removed by the surgeon and under the cut-off procedure of the mucoperiosteal envelope flap (in case of need for surgery) or by simple tooth extraction. Then, according to a randomized random number, in the cavity of the tooth extracted, the area of 4 cm 2 of the bioadhesive contains 20% ginger extract will be replaced or 1.8 ml of the dexamethasone dose of 1.6 mg will be injected. The degree of opening the patient's mouth (Trismus status) and the distance between the commisure of oral cavity of the patient and the tragus of his ear (checking the status of swelling) will be measured and recorded before surgery, 24 hours and 72 hours after surgery. A translated VAS pain intensity questionnaire will be provided for patients and they will determine the amount of pain in the respective hours (surgery day and one to three days after surgery). Also, in connection with taking medications, he will be allowed to use acetaminophen codoine 300 mg in case of severe pain. In addition to the numbers of the VAS scale, the number of acetaminophen codin 300 mg tablets taken will be reported to the researcher in each of the days (surgery day and one to three days after surgery). The opening of the mouth and the tragus distance to the corner of his lips, which is considered as a criterion for trismus and swelling of the position, will be measured and recorded by the researcher before surgery 24 hours and 72 hours after surgery. The patient is taking antibiotics amoxicillin 500 and metronidazole 400 every 8 hours and mouthwash (spatula twice a day) up to one week..
public Sahar Zandi
Imam Khomeini Street, Bushehr University of Medical Sciences, Faculty of Dentistry
Bushehr Iran (Islamic Republic of) 7514633341 +98 77 3356 5374 s.zandi@bpums.ac.irsaharzandi72@yahoo.com School of Dentistry, Bushehr University of Medical Sciences scientific Saman jokar
Imam Khomeini Street, Bushehr University of Medical Sciences, Faculty of Dentistry
Bushehr Iran (Islamic Republic of) 7514633341 +98 77 3356 5374 saman.jokar@yahoo.com Bushehr University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: The patient has a double-walled tooth (based on the angle of tooth placement in the jaw, the amount of bone and soft tissue on the tooth, the condition of the tooth in relation to the anterior border of ramus), the willingness to cooperate And there is no prohibition of tooth surgery or sensitivity to ginger. The tooth does not have any pathological lesions in the root zone in clinical and radiographic examinations. No other surgical procedures for at least two weeks. Exclusion criteria: kidney or liver disease, bleeding problems such as hemophilia, neutropenia, blood platelet deficiency, etc., previous or current stomach ulcers, any heart disease, Known allergies, allergies, or individual reactions to either the drugs used or the drugs that may be used in the study (ginger, lidocaine anesthesia, acetaminophen codine 300, gelofen 400, amoxicillin 500, and metronidazole 400 mg G) Pregnancy and lactation, taking analgesic or anti-inflammatory drugs 24 hours before the study, having pain and other inflammatory symptoms including swelling, high blood pressure and the inability to open the mouth before the study. no limit no limit Both Treatment - Drugs In this double-blind clinical trial, anti-inflammatory and anti-inflammatory effects of topical administration of a 20% tissue bioadhesive made of 100% ginger extract and a mucosal dexamethasone injection of 1.6 mg after extraction of the wisdom teeth will be compared. The similarity of the mandibular teeth is performed by a qualified expert oral and maxillofacial radiologist through panoramic radiography images based on the indications in the radiology images and the classifications available in reference books as well as by a clinical examination by a oral and maxillofacial surgeon. The angle of tooth placement in the jaw, the amount of bone and soft tissue on the tooth, and the tooth position should be similar. Each patient will take amoxicillin 500 mg and metronidazole 400 mg 30 minutes before startingextraction. For each patient, the choice of which treatment is to be done on his right or left tooth will be done using random numbers. Patients will be injected with two carpool of lidocaine anesthetics with inferior alveolar nrve block technique, then removed by the surgeon and under the cut-off procedure of the mucoperiosteal envelope flap (in case of need for surgery) or by simple tooth extraction. Then, according to a randomized random number, in the cavity of the tooth extracted, the area of 4 cm 2 of the bioadhesive contains 20% ginger extract will be replaced or 1.8 ml of the dexamethasone dose of 1.6 mg will be injected. The degree of opening the patient's mouth (Trismus status) and the distance between the commisure of oral cavity of the patient and the tragus of his ear (checking the status of swelling) will be measured and recorded before surgery, 24 hours and 72 hours after surgery. A translated VAS pain intensity questionnaire will be provided for patients and they will determine the amount of pain in the respective hours (surgery day and one to three days after surgery). Also, in connection with taking medications, he will be allowed to use acetaminophen codoine 300 mg in case of severe pain. In addition to the numbers of the VAS scale, the number of acetaminophen codin 300 mg tablets taken will be reported to the researcher in each of the days (surgery day and one to three days after surgery). The opening of the mouth and the tragus distance to the corner of his lips, which is considered as a criterion for trismus and swelling of the position, will be measured and recorded by the researcher before surgery 24 hours and 72 hours after surgery. The patient is taking antibiotics amoxicillin 500 and metronidazole 400 every 8 hours and mouthwash (spatula twice a day) up to one week. The amount of pain. Timepoint: Day of intervention, one day after intervention, two days after intervention, three days after intervention. Method of measurement: VAS scale (number). Mouth opening rate. Timepoint: Pre-intervention, 24 hours after intervention, 72 hours after intervention. Method of measurement: Millimeters. Distance between the corner of the mouth and the tragus. Timepoint: Pre-intervention, 24 hours after intervention, 72 hours after intervention. Method of measurement: Millimeters. The amount of acetaminophen codoine 300 mg taken. Timepoint: Day of intervention, one day after intervention, two days after intervention, three days after intervention. Method of measurement: questionnaire. Age. Timepoint: Before intervention. Method of measurement: questionnaire. Gender. Timepoint: Before intervention. Method of measurement: questionnaire. Infection. Timepoint: Before intervention, 24 hours after intervention, 72 hours after intervention. Method of measurement: View, interview. Any other anti-inflammatory or analgesic drug. Timepoint: three days after the intervention. Method of measurement: questionnaire. The Vice-Chancellor of Research of Bushehr University of Medical Sciences Approved 2016-05-14 The Ethics Committee of the Vice-Chancellor of Research of Bushehr University of Medical Sciences Imam Khomeini Ave (Bushehr), Bushehr University of Medical Sciences, Faculty of Dentistry Bushehr Iran (Islamic Republic of)