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IRCT20211028052898N1 IRCT 2021-11-20 Arak University of Medical Sciences Study of the effect of submucosal and intramuscular injection of dexamethasone before and after mandibular impacted wisdom tooth surgery in reducing postoperative swelling and trismus Study of the effect of submucosal and intramuscular injection of dexamethasone before and after mandibular impacted wisdom tooth surgery in reducing postoperative swelling and trismus 2021-11-02 anticipated 72 Complete https://irct.ir/trial/59657 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The sampling method is regular random, by random numbers. That is, after examination and approval of patients by a specialist on panoramic graphics, patients were randomly placed in a list of 72 people in order of inclusion in the study. Quadratic numbers starting with 1 in group A, numbers with quadratic interval starting from 2 in group B, numbers with quadratic interval starting from 3 in group C and numbers with quadratic interval starting from 4 in group D, are divided, Blinding description: Only the surgeon, who is injecting the anesthetic and corticosteroids, is aware of the groups of patients. The student who records the level of swelling and trismus of patients is not aware of the patient group and therefore the study is one-sided blind. 2 Swelling and trismus after impacted mandibular wisdom tooth surgery. Intervention 1: Patients are 18 to 35 years old. All patients have third mandibular molar surgery in hard tissue. In 4 groups, inferior alveolar nerve and long buccal nerve block is performed with lidocaine. All surgeries are performed by an experienced surgeon with the same technique. Alborz Daroo is the commercial company that produces all dexamethasone. All patients receive 500 mg amoxicillin, 400 mg ibuprofen, and chlorhexidine mouthwash after surgery. All surgeries are performed by a surgeon, and in each surgery the type of flap created is triangular. Intervention group 1: receives 4 mg of intramuscular dexamethasone before surgery. Intervention 2: Intervention group 2: receives 4 mg of intramuscular dexamethasone after surgery. Intervention 3: Intervention group 3: receives 4 mg of submucosal dexamethasone before surgery. Intervention 4: Intervention group 4: receives 4 mg of submucosal dexamethasone after surgery. Yes - There is a plan to make this available What will be shared: Only part of the data, such as the original outcome information, can be shared. When: The access period starts one year after the results are published. To whom: The data will be available to all researchers. Conditions: Any kind of analysis on the delivered data is allowed. Where to obtain: Mehdi Ebrahimi, 09015954041, ebrahimimehdi96@gmail.com How to obtain: After submitting the application to the mentioned e-mail address, the documents will be sent to the applicant within one week. Comments:
public Mehdi Heydarizade
5th floor - Bouali Building - Khorram Street
Arak Iran (Islamic Republic of) 3819748585 +98 86 3312 8233 ebrahimimehdi96@gmail.com Arak University of Medical Sciences scientific Mehdi Heydarizade
5th floor - Bouali Building - Khorram Street
Arak Iran (Islamic Republic of) 3819748585 +98 86 3312 8233 ebrahimimehdi96@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Patients with impacted mandibular wisdom teeth who do not have pericoronitis. Patients with impacted mandibular wisdom teeth who do not have a local infection. Patients with impacted mandibular wisdom teeth over 18 years of age. Patients with impacted mandibular wisdom teeth who are not taking antibiotics or anti-inflammatory drugs. Patients with impacted mandibular wisdom teeth who do not have systemic problems and allergies. 18 years 35 years Both Pregnant people. People with allergies to the drugs used in the study. Patients with local infection. Patients taking antibiotics or anti-inflammatory drugs. Patients with systemic problems and allergies. Patients with pericoronitis. Prevention Prevention Prevention Prevention Patients are 18 to 35 years old. All patients have third mandibular molar surgery in hard tissue. In 4 groups, inferior alveolar nerve and long buccal nerve block is performed with lidocaine. All surgeries are performed by an experienced surgeon with the same technique. Alborz Daroo is the commercial company that produces all dexamethasone. All patients receive 500 mg amoxicillin, 400 mg ibuprofen, and chlorhexidine mouthwash after surgery. All surgeries are performed by a surgeon, and in each surgery the type of flap created is triangular. Intervention group 1: receives 4 mg of intramuscular dexamethasone before surgery. Intervention group 2: receives 4 mg of intramuscular dexamethasone after surgery. Intervention group 3: receives 4 mg of submucosal dexamethasone before surgery. Intervention group 4: receives 4 mg of submucosal dexamethasone after surgery. Trismus after impacted mandibular wisdom tooth surgery. Timepoint: At the beginning of the study (before the intervention) and 72 hours after the intervention. Method of measurement: Measurement of the boundary line between the incisive edge of the upper and lower incisors at maximum mouth opening by a calibrated ruler. Swelling after mandibular wisdom tooth surgery. Timepoint: At the beginning of the study (before the intervention) and 72 hours after the intervention. Method of measurement: Using a tape measure, the distance between the earlobe to the corner of the mouth (Method A) and the inner corner of the eye to the mandibular angle (Method B). Arak University of Medical Sciences Approved 2021-11-02 Ethics committee of Arak University of Medical Sciences 13th floor, Block A, Treatment and Medical Education, Central Headquarters of the Ministry of Health, between South Flamek and Zarafshan, Iran TV St, Ghods Town (West), Tehran Tehran Tehran Iran (Islamic Republic of)