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IRCT20131205015665N4 IRCT 2020-07-10 Esfahan University of Medical Sciences Evaluation of the effect of green tea extract on the postoperative pain following surgical removal of the impacted mandibular wisdom tooth Evaluation of the effect of green tea extract on the postoperative pain following surgical removal of the impacted mandibular third molar 2018-05-22 anticipated 32 Complete https://irct.ir/trial/49301 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: split-mouth design, Randomization description: pseudorandomization will be performed in this study. after considering an identification number from 1 to 32 for each patient; in patients with an odd ID number, green tea-impregnated gauze will be used on the right side and saline-impregnated gauze will be applied to the left side. in patients with an even ID number, green tea-impregnated gauze will be used on the left side and saline-impregnated gauze will be applied to the right side, Blinding description: for blinding the participants: they will not be aware of the exact location of application of the green tea-impregnated gauze after surgery for blinding the care provider: the surgeon will not be aware of the exact location of application of the green tea-impregnated gauze after surgery and application of the gauze and patient's instruction will be performed by the researcher and in the absence of the surgeon. N/A evaluation of the postoperative pain following application of the green tea-impregnated gauze after surgical extraction of the impacted mandibular third molar. Intervention 1: Intervention group 1: All the surgeries will be performed by an experienced surgeon using the same protocol: the povidone-iodine solution will be applied to the surgical site; 2% lidocaine and 1:80,000 epinephrine (Iran, Tehran, Exir) will be used to block the inferior alveolar and long buccal nerves; a mucoperiosteal envelop flap will be created using a standard incision; if needed, bone removal, tooth sectioning, and bone recontouring will be performed with a low-speed hand-piece under sufficient sterile solution irrigation; following tooth removal the socket will be irrigated with 60 ml of saline; the flap will be sutured using 3–0 silk sutures. Green tea extract-impregnated sterile gauze will be used after removing the right or left tooth, according to the randomized order specified before and based on the patient's ID number. Both patients and surgeons will be blinded to the type of gauze. Iranian green tea will be purchased from the market (Iran, Mashhad, Zarghani company). For the preparation of hydroalcoholic extract, green tea will be powdered and 300 grams of the powder will be macerated by 1500 ml of ethanol 70% (v/v) for 72 hours. The extract will be then shaken, filtered and the solvent will be removed in a vacuum evaporator to obtain a semi-solid extract, and then it will be placed in an oven at 60°C for 72 hours. Patients will be instructed to take no painkiller or narcotics 12 hours before the procedure. As the surgery finished they will be given 10 Advalgine (Ibuprofen Lysine 400 mg) tablets and told to use them as the only medication for pain relief. They also will be instructed not to drink green tea beverages 48 hours after the operation. Respectively 6, 12, 24, and 48 hours after the end of the procedure by telephone contact, they will be asked about the presence and intensity of pain on the surgical site. On the third day after the operation, patients will be examined by the surgeon to note if they had experienced a dry socket. The decrease in the VAS pain scores as well as the number of analgesics used will be calculated for each patient. Intervention 2: Intervention group 2: All the surgeries will be performed by an experienced surgeon using the same protocol: the povidone-iodine solution will be applied to the surgical site; 2% lidocaine and 1:80,000 epinephrine (Iran, Tehran, Exir) will be used to block the inferior alveolar and long buccal nerves; a mucoperiosteal envelop flap will be created using a standard incision; if needed, bone removal, tooth sectioning, and bone recontouring will be performed with a low-speed hand-piece under sufficient sterile solution irrigation; following tooth removal the socket will be irrigated with 60 ml of saline; the flap will be sutured using 3–0 silk sutures. Green tea extract-impregnated sterile gauze will be used after removing the right or left tooth, according to the randomized order specified before and based on the patient's ID number. Both patients and surgeons will be blinded to the type of gauze. Patients will be instructed to take no painkiller or narcotics 12 hours before the procedure. As the surgery finished they will be given 10 Advalgine (Ibuprofen Lysine 400 mg) tablets and told to use them as the only medication for pain relief. They also will be instructed not to drink green tea beverages 48 hours after the operation. Respectively 6, 12, 24, and 48 hours after the end of the procedure by telephone contact, they will be asked about the presence and intensity of pain on the surgical site. On the third day after the operation, patients will be examined by the surgeon to note if they had experienced a dry socket. The decrease in the VAS pain scores as well as the number of analgesics used will be calculated for each patient. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is no further information
public Milad Etemadi Shalamzari
Department of oral and maxillofacial surgery, dentistry faculty, Isfahan university of medical sciences, Hezar-jerib st., Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5581 etemadi@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Milad Etemadi Shalamzari
Department of oral and maxillofacial surgery, dentistry faculty, Isfahan university of medical sciences, Hezar-jerib st., Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5581 etemadi@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Having bilateral impacted mandibular third molar with the same difficulty based on the spatial direction of the teeth (mesioangular) on preoperative panoramic radiography Having bilateral impacted mandibular third molar with the same difficulty based on the depth of impaction (Pell & Gregory classifications/type B) on preoperative panoramic radiography Having bilateral impacted mandibular third molar with the same difficulty based on the relationship with the anterior border of the ramus (class 1) on preoperative panoramic radiography 18 years 30 years Both having allergy to green tea products being younger than 18 years old or having more than 30 years of age receiving other drugs like antibiotics, analgesics, and herbal therapy for pain/ infection in the last 30 days presence of any kind of lesion (benign or malignant) in the site of surgery before surgery pregnancy and/or lactation systemic health problems presence or history of pain in the maxillofacial region like temporomandibular joint disorder (TMD) or myofascial pain and dysfunction syndrome (MPDS) before surgery presence of pulpitis drug addiction (methamphetamine, ephedrine, or cocaine) G89.18 Other acute postprocedural pain Treatment - Other Treatment - Other Intervention group 1: All the surgeries will be performed by an experienced surgeon using the same protocol: the povidone-iodine solution will be applied to the surgical site; 2% lidocaine and 1:80,000 epinephrine (Iran, Tehran, Exir) will be used to block the inferior alveolar and long buccal nerves; a mucoperiosteal envelop flap will be created using a standard incision; if needed, bone removal, tooth sectioning, and bone recontouring will be performed with a low-speed hand-piece under sufficient sterile solution irrigation; following tooth removal the socket will be irrigated with 60 ml of saline; the flap will be sutured using 3–0 silk sutures. Green tea extract-impregnated sterile gauze will be used after removing the right or left tooth, according to the randomized order specified before and based on the patient's ID number. Both patients and surgeons will be blinded to the type of gauze. Iranian green tea will be purchased from the market (Iran, Mashhad, Zarghani company). For the preparation of hydroalcoholic extract, green tea will be powdered and 300 grams of the powder will be macerated by 1500 ml of ethanol 70% (v/v) for 72 hours. The extract will be then shaken, filtered and the solvent will be removed in a vacuum evaporator to obtain a semi-solid extract, and then it will be placed in an oven at 60°C for 72 hours. Patients will be instructed to take no painkiller or narcotics 12 hours before the procedure. As the surgery finished they will be given 10 Advalgine (Ibuprofen Lysine 400 mg) tablets and told to use them as the only medication for pain relief. They also will be instructed not to drink green tea beverages 48 hours after the operation. Respectively 6, 12, 24, and 48 hours after the end of the procedure by telephone contact, they will be asked about the presence and intensity of pain on the surgical site. On the third day after the operation, patients will be examined by the surgeon to note if they had experienced a dry socket. The decrease in the VAS pain scores as well as the number of analgesics used will be calculated for each patient. Intervention group 2: All the surgeries will be performed by an experienced surgeon using the same protocol: the povidone-iodine solution will be applied to the surgical site; 2% lidocaine and 1:80,000 epinephrine (Iran, Tehran, Exir) will be used to block the inferior alveolar and long buccal nerves; a mucoperiosteal envelop flap will be created using a standard incision; if needed, bone removal, tooth sectioning, and bone recontouring will be performed with a low-speed hand-piece under sufficient sterile solution irrigation; following tooth removal the socket will be irrigated with 60 ml of saline; the flap will be sutured using 3–0 silk sutures. Green tea extract-impregnated sterile gauze will be used after removing the right or left tooth, according to the randomized order specified before and based on the patient's ID number. Both patients and surgeons will be blinded to the type of gauze. Patients will be instructed to take no painkiller or narcotics 12 hours before the procedure. As the surgery finished they will be given 10 Advalgine (Ibuprofen Lysine 400 mg) tablets and told to use them as the only medication for pain relief. They also will be instructed not to drink green tea beverages 48 hours after the operation. Respectively 6, 12, 24, and 48 hours after the end of the procedure by telephone contact, they will be asked about the presence and intensity of pain on the surgical site. On the third day after the operation, patients will be examined by the surgeon to note if they had experienced a dry socket. The decrease in the VAS pain scores as well as the number of analgesics used will be calculated for each patient. Severity of the pain based on Visual analogue scale (VAS). Timepoint: evaluation of the severity of the pain 6, 12, 24, and 48 hours after surgery. Method of measurement: using Visual analogue scale (VAS). Number of analgesics (ibuprofen) used after surgery. Timepoint: 6, 12, 24,and 48 hours after surgery. Method of measurement: asking the patient. Esfahan University of Medical Sciences Approved 2018-05-15 Ethics committee of Isfahan university of medical sciences oral and maxillofacial surgery department, dentistry faculty, Isfahan university of medical sciences,Hezar-jerib st., Isfahan, Iran. Isfahan Isfehan Iran (Islamic Republic of)