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IRCT20200705048014N2 IRCT 2022-09-28 Bandare-abbas University of Medical Sciences Investigating the effect of amoxicillin in reducing infection after impacted wisdom tooth surgery Comparison of the effects of amoxicillin Prescribed and not prescribed amoxicillin on complications after mandibular impacted wisdom tooth surgery in patients without systemic problems. 2022-09-23 anticipated 40 Complete https://irct.ir/trial/65493 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: The number of 40 patients without systemic disease, not taking drugs that interfere with the tested drugs and psychotic drugs, as well as the presence of a mandibular wisdom tooth with a moderate degree of difficulty will be included in the study. Patients in two groups of 20: First group: Placebo prescription every 8 hours for 5 days.The second group: Amoxicillin 500 mg every 8 hours for 5 days.Patients are randomly divided by PASS software. All surgeries will be performed by one surgeon using the same protocol and type of flap and surgical technique as well as the amount of bone removal. The tested drugs, including amoxicillin and placebo amoxicillin, are placed inside the same boxes, and the patient will be instructed to use them by a colleague who is not aware of the contents of the boxes. It is explained to the patients that in case of any special problem or evidence of infection, they should call or refer to the hospital, otherwise, they should return for examination 7 days after the surgery.In this follow-up session, the sutures are removed and the parameters of halitosis and pus discharge are examined, and the amount of erythema will be evaluated qualitatively based on the extent and intensity of redness. The severity of trismus is evaluated by measuring the distance between the incisor teeth at the maximum opening of the patient's mouth using a gauge. All clinical evaluations will be measured by a surgeon who is not aware of the type of antibiotic taken by the patient, Randomization description: Using Sealed envelope statistical software, we perform randomization by block randomization method, blocks of 4 are divided into two groups (group A is considered intervention and group B is considered control), concealment is done by this software and the last group is not predictable. The randomization unit is individual, Blinding description: It is explained to the patients that they will participate in an experimental study and that the prescription of antibiotics after wisdom tooth surgery is not necessary according to the dental reference books and that the boxes provided to them may contain amoxicillin or amoxicillin placebo which is similar in shape. And the size is similar to it, but the rest of the treatment process is completely similar to other patients. All surgeries will be performed by the same surgeon using the same protocol and type of flap and surgical technique, as well as the amount of bone removal.Then, using the codes given to the nurse, coded boxes will be given to the patients, which must be taken every 8 hours for 5 days. Amoxicillin and placebo capsules are the same in terms of shape, color and size and in the same packaging. 7 days later, patients will be examined by the surgeon who performed the surgery. 3 . Intervention 1: Mandibular impacted wisdom tooth surgery of class 1B type, which has moderate difficulty, is performed for patients with a similar protocol that includes the removal of a small amount of bone (less than 3 mm) by a surgical bur, tooth loosening with an elevator, and extraction with forceps. It should be noted that the instruments were thoroughly checked for sterility and all the instruments will be sterile and all procedures will be performed with sterile surgical gloves. After the surgery, the intervention group received amoxicillin 500 mg boxes made by Dana Pharmaceutical Company every 8 hours. It will be received for 5 days. Intervention 2: Control group: Mandibular impacted wisdom tooth surgery of type 1B, which has moderate difficulty, with a similar protocol that includes the removal of a small amount of bone (less than 3 mm) by surgical bur, tooth loosening with elevator and extraction with forceps for patients is done.It should be noted that the instruments were thoroughly checked for sterility and all the instruments will be sterile and all the procedures will be performed with sterile surgical gloves. day will be used. Yes - There is a plan to make this available What will be shared: All data is playable after de-identifying participants When: 6 months after registering the results To whom: Academic researchers Conditions: Systematic review articles Where to obtain: Email:faribahabiby@gmail.com Its owner is Fariba Habibi How to obtain: Send email Comments:
public Mohammadreza Moaddeli
Nasser Boulevard, Shariati Hospital, Bandar Abbas School of Dentistry
Bandar Abbas Iran (Islamic Republic of) 1468613684 +98 939 479 0860 faribahabiby@gmail.com Bandare-abbas University of Medical Sciences scientific Mohammad Reza Moaddeli
Imam Khomeini Blvd.
Badar Abbas Iran (Islamic Republic of) 1468613684 +98 76 3335 0458 m.moaddeli@hums.ac.ir Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) All patients between the ages of 18 and 60, of both sexes, without systemic problems, who refer for mandibular wisdom tooth surgery. 18 years 60 years Both The patient's lack of consent to cooperate receiving antibiotics in the last three months Failure to strictly follow the instructions after the operation Patients who have unusual problems during tooth extraction Existence of systemic diseases and pregnant women Presence of infection in the patient The patient's sensitivity to amoxicillin Treatment - Drugs Placebo Mandibular impacted wisdom tooth surgery of class 1B type, which has moderate difficulty, is performed for patients with a similar protocol that includes the removal of a small amount of bone (less than 3 mm) by a surgical bur, tooth loosening with an elevator, and extraction with forceps. It should be noted that the instruments were thoroughly checked for sterility and all the instruments will be sterile and all procedures will be performed with sterile surgical gloves. After the surgery, the intervention group received amoxicillin 500 mg boxes made by Dana Pharmaceutical Company every 8 hours. It will be received for 5 days Control group: Mandibular impacted wisdom tooth surgery of type 1B, which has moderate difficulty, with a similar protocol that includes the removal of a small amount of bone (less than 3 mm) by surgical bur, tooth loosening with elevator and extraction with forceps for patients is done.It should be noted that the instruments were thoroughly checked for sterility and all the instruments will be sterile and all the procedures will be performed with sterile surgical gloves. day will be used. Wound healing process. Timepoint: 7 days after surgery. Method of measurement: Clinical examination of the wound. Pain after surgery. Timepoint: Daily up to 7 days after surgery. Method of measurement: Question from the patient and rating from 1 to 5. Erythema in the area. Timepoint: 7 days after surgery. Method of measurement: Physical examination. Halitosis. Timepoint: Daily until seven days after surgery. Method of measurement: Ask the patient. Trismus. Timepoint: 7 days after surgery. Method of measurement: Clinical examination using a ruler with millimeter unitsCommunity Verified icon. student Approved 2022-07-30 Ethics Committee of Hormozgan University of Medical Sciences Shariati Dental Clinic, Nasser Blvd Bandar abbas Hormozgan Iran (Islamic Republic of)