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IRCT20221201056682N1 IRCT 2023-07-17 Qazvin University of Medical Sciences Effect of Bupivacaine hydrogel on post-operation pain in impacted wisdom tooth Evaluation the effect of Carbomer based Bupivacaine hydrogel on post-operation pain in impacted mandibular wisdom tooth 2023-09-10 anticipated 16 Complete https://irct.ir/trial/70913 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Patients' teeth are allocated to two treatment groups A and B using the method of random blocks (Balance block randomization), the size of each block is 4 and the total number of blocks is 4 as described in the attached table. The method of allocation of balanced randomization for participants in a randomized controlled clinical trial study is the effect of hydrogel containing bupivacaine based on carbomer (group A) and placebo hydrogel (group B) in reducing mandibular wisdom tooth surgery. block identifier block size sequence within block treatment 1 4 1 Group A 1 4 2 Group A 1 4 3 Group B 1 4 4 Group B 2 4 1 Group A 2 4 2 Group B 2 4 3 Group A 2 4 4 Group A 3 4 1 Group B 3 4 2 Group A 3 4 3 Group A 3 4 4 Group B 4 4 1 Group A 4 4 2 Group A 4 4 3 Group B 4 4 4 Group B, Blinding description: The sampling method is split mouth, in which one patient's tooth on one side is randomly selected during surgery by another person, and the desired hydrogel (A or B) is used. The patient does not know which of the hydrogels has been used in his mouth. Also, the outcome assessor is uninformed. The statistical analyzer does not know the type of hydrogel and groups. 2-3 post operation pain. Intervention 1: Intervention group: Carbomer-based hydrogel was prepared by the pharmaceutical department of Shahid Beheshti Faculty of Pharmacy with a ratio of 7.5 mg/cc of the active ingredient in antiseptic conditions with sterile materials, and after the completion of the manufacturing process, the hydrogel was poured into sterile falcon tubes and sterilized by gamma radiation. and finally its lid is sealed with cellulose until consumption. The hydrogel containing bupivacaine is measured using a spectrophotometer to measure the release rate of the drug at zero, 40 minutes, 24 and 48 hours. In wisdom tooth surgery, before starting, the patient's pain level, if any, is stated and marked on the VAS chart. Then the inferior alveolar nerve (IAN) block injection will be done using 3% prilocaine and directly. Long buccal injection is also performed using 2% lidocaine. Then, after 10 minutes, a pocket-shaped flap is cut from the mesial of the first molar on the buccal side to the beginning of the ramus, and the flap is gently separated from the bone using a periosteal elevator. By removing the bone around the tooth if needed and sectioning the tooth using a round and fissure bur, we remove the tooth in several parts using an elevator. Then we curettage the sac and wash it with normal saline and put 1 cc of hydrogel containing bupivacaine in the sac and sew it with 4 zero polyglycolic acid (P.G.A) thread. We prescribe antibiotics metronidazole 250 mg (1 tablet every 8 hours) and amoxicillin 500 mg (1 tablet every 8 hours) to the patients. Also, the patient is told to take ibuprofen 400 mg in case of pain. Intervention 2: Control group: Placebo hydrogel based on carbomer was prepared by the Pharmaceuticals Department of Shahid Beheshti Faculty of Pharmacy in antiseptic conditions with sterile materials and after the completion of the manufacturing process, the hydrogel was poured into sterile falcon tubes and sterilized with gamma rays and finally closed with cellulose. It is sealed until consumption. In wisdom tooth surgery, before starting, the patient's pain level, if any, is stated and marked on the VAS chart. Then the inferior alveolar nerve (IAN) block injection will be done using 3% prilocaine and directly. Long buccal injection is also performed using 2% lidocaine. Then, after 10 minutes, a pocket-shaped flap is cut from the mesial of the first molar on the buccal side to the beginning of the ramus, and the flap is gently separated from the bone using a periosteal elevator. By removing the bone around the tooth if needed and sectioning the tooth using a trend and fissure bur, we remove the tooth in several parts using an elevator. Then we curettage the sac and wash it with normal saline and place 1 cc of placebo hydrogel in the sac and suture it with 4 zero polyglycolic acid (P.G.A) thread. We prescribe antibiotics metronidazole 250 mg (1 tablet every 8 hours) and amoxicillin 500 mg (1 tablet every 8 hours) to the patients. Also, the patient is told to take ibuprofen 400 mg in case of pain. Yes - There is a plan to make this available What will be shared: The data includes non-identifiable information of the patients such as gender, age, VAS data about the patients' pain and the number of painkillers they take. Also, the details of the hydrogel production can be provided and shared if the conditions mentioned below are followed. When: Access to study data begins 3 months after publication of results To whom: The data will be available to researchers working in academic and scientific institutions. Conditions: The given data can be used for any statistical analysis, but the use of the hydrogel formulation data for manufacturing or commercialization depends on informing the researchers of this study. Where to obtain: In order to access the data, they can contact Mr. Erfan Khorasani and the email mentioned below. e.khorasani@qums.ac.ir How to obtain: After mentioning the details of data usage by the requester and also providing valid identification information, within one week to ten working days, the data will be provided to them via email. Comments:
public Erfan Khorasani
Qazvin dental school, Bahonar Blvd, Qazvin
Qazvin Iran (Islamic Republic of) 3419759811 009833353061 e.khorasani@qums.ac.ir Qazvin University of Medical Sciences scientific Pejman Janbaz Asiabar
Qazvin dental school, Bahonar Blvd, Qazvin
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3335 3061 pejmanjanbaz@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) patients with impacted mesioangular mandibular wisdom teeth class B and C of Pell and Gregory classification Growth of at least 1/2 to 2/3 of the wisdom tooth root 18 years no limit Both Patients with other than mesioangular depression and other Pell and Gregory classes Continuous use of opioid and non-steroidal pain medications The presence of any systemic disease Allergy to bupivacaine or carbomer Treatment - Drugs Placebo Intervention group: Carbomer-based hydrogel was prepared by the pharmaceutical department of Shahid Beheshti Faculty of Pharmacy with a ratio of 7.5 mg/cc of the active ingredient in antiseptic conditions with sterile materials, and after the completion of the manufacturing process, the hydrogel was poured into sterile falcon tubes and sterilized by gamma radiation. and finally its lid is sealed with cellulose until consumption. The hydrogel containing bupivacaine is measured using a spectrophotometer to measure the release rate of the drug at zero, 40 minutes, 24 and 48 hours. In wisdom tooth surgery, before starting, the patient's pain level, if any, is stated and marked on the VAS chart. Then the inferior alveolar nerve (IAN) block injection will be done using 3% prilocaine and directly. Long buccal injection is also performed using 2% lidocaine. Then, after 10 minutes, a pocket-shaped flap is cut from the mesial of the first molar on the buccal side to the beginning of the ramus, and the flap is gently separated from the bone using a periosteal elevator. By removing the bone around the tooth if needed and sectioning the tooth using a round and fissure bur, we remove the tooth in several parts using an elevator. Then we curettage the sac and wash it with normal saline and put 1 cc of hydrogel containing bupivacaine in the sac and sew it with 4 zero polyglycolic acid (P.G.A) thread. We prescribe antibiotics metronidazole 250 mg (1 tablet every 8 hours) and amoxicillin 500 mg (1 tablet every 8 hours) to the patients. Also, the patient is told to take ibuprofen 400 mg in case of pain. Control group: Placebo hydrogel based on carbomer was prepared by the Pharmaceuticals Department of Shahid Beheshti Faculty of Pharmacy in antiseptic conditions with sterile materials and after the completion of the manufacturing process, the hydrogel was poured into sterile falcon tubes and sterilized with gamma rays and finally closed with cellulose. It is sealed until consumption. In wisdom tooth surgery, before starting, the patient's pain level, if any, is stated and marked on the VAS chart. Then the inferior alveolar nerve (IAN) block injection will be done using 3% prilocaine and directly. Long buccal injection is also performed using 2% lidocaine. Then, after 10 minutes, a pocket-shaped flap is cut from the mesial of the first molar on the buccal side to the beginning of the ramus, and the flap is gently separated from the bone using a periosteal elevator. By removing the bone around the tooth if needed and sectioning the tooth using a trend and fissure bur, we remove the tooth in several parts using an elevator. Then we curettage the sac and wash it with normal saline and place 1 cc of placebo hydrogel in the sac and suture it with 4 zero polyglycolic acid (P.G.A) thread. We prescribe antibiotics metronidazole 250 mg (1 tablet every 8 hours) and amoxicillin 500 mg (1 tablet every 8 hours) to the patients. Also, the patient is told to take ibuprofen 400 mg in case of pain. Patient's post operation pain scale. Timepoint: measure pain in 2, 6, 12, 24, 48 and 72 hours after surgery. Method of measurement: Visual Analogue Scale. Painkiller usage. Timepoint: 2, 6, 12, 24, 48 and 72 hours after surgery. Method of measurement: self statement. Qazvin University of Medical Sciences Approved 2023-07-12 Research Ethics committee of Qazvin university of medical sciences Research and Technology Deputy, 1st sub-district, Mavedat Alley, Beheshti Blvd, Qazvin Qazvin Qazvin Iran (Islamic Republic of)