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IRCT20230210057378N1 IRCT 2023-03-18 Qazvin University of Medical Sciences Comparing anesthetic efficacy of 4% Articaine and 2% Lidocaine in mandibular bone grafts Comparing anesthetic efficacy of 4% Articaine and 2% Lidocaine as buccal infiltration in mandibular ramus block harvesting for bone augmentation in implant patients requirin bone augmentation 2023-03-11 anticipated 20 Complete https://irct.ir/trial/68521 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be divided into two groups of 4% Artecaine and 2% Lidocaine in the form of blocked randomization. Blocking and sequencing of samples will be done with random allocation software. In order to conceal the random allocation process, the names of the groups are placed in envelopes, numbered on these envelopes from 1 to ... and arranged in a box in order. The researcher who performs the random allocation will not be aware of the contents of the envelopes. The contents of the envelopes indicate the study groups (intervention or placebo) and after ensuring that the sample enters the research and obtaining written consent, the first envelope is taken in order of number and according to the contents of the envelope in are included in one of the study groups, Blinding description: This study will be done in a double-blind manner. In this way, the examined patients and the observer will be unaware of the type of intervention. Patients will be given a full explanation of the intervention to be performed with details, but the type of local anesthetic used will remain hidden from them. The type of local anesthetic is determined according to the sealed letter that has been prepared in advance, but the therapist, who is also a researcher, is unaware of the type of local anesthetic and will only know whether it is group one or two. Grouping is done randomly as described above. Cartridges containing anesthetic solutions, with the type of solution and its specifications written on it, are covered with a opaque cover so that only their expiration date is known. On the opaque cover, the anesthetic group (one or two) is written. 3 Severe bone defects in the jaws. Intervention 1: Control group: Lidocaine local anesthetic 2% - Persocaine-E (lidocaine) 2% manufactured by Daroopakhsh company - each cartridge contains 1.8 ml anesthetic solution - 12.5 micrograms epinephrine - 38 mg lidocaine hydrochloride. For each patient, an anesthetic cartridge is injected in the posterior buccal of the mandible in the form of infiltration. Intervention 2: Intervention group: Articaine local anesthetic 4%- Artheek 4% manufactured by New Stetic Company - each cartridge contains 1.8 ml anesthetic solution - 18 micrograms of epinephrine - 72 mg of articaine hydrochloride. For each patient, an anesthetic cartridge is injected in the posterior buccal of the mandible in the form of infiltration. Yes - There is a plan to make this available What will be shared: All potential data will be shared after de-identifying individuals. When: The access period starts 6 months after the results are published To whom: All people, including researchers working in academic and scientific institutions and those working in the industry Conditions: The data/documentation can be used for scientific purposes, for use in other articles, and for dentists to increase their clinical knowledge. Where to obtain: To receive information about the data, please email Mr. Amir Hasanpour as the responsible researcher. E-mail address: ahasanpour23@gmail.com How to obtain: Send an email to the address listed above Comments:
public Amir Hasanpour
No3, 5th Velayat alley, Talim Ave, Matahari Blvd
الوند Iran (Islamic Republic of) 3414754615 +98 28 3366 4815 ahasanpour23@gmail.com Qazvin University of Medical Sciences scientific Farshid Rayati
No. 3, 5th Velayat alley, Talim Ave, Motahari Blvd
Qazvin Iran (Islamic Republic of) 3414754615 +98 28 3366 4815 Farshidrayati@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) People between 18 and 65 years old Systemically healthy people Having the ability to fill out questionnaires People with bone defects in the edentulous area and candidate for bone graft People who need implants in the upper jaw or the opposite side of the bone removal area in the lower jaw (contralateral) 18 years 65 years Both Presence of an abscess or any pathological lesion at the injection site History of diabetes, cardiovascular diseases, hypertension and kidney diseases History of allergy to Lidocaine or Articaine local anesthetics Consumption of alcohol or any pain reliever Mentally unable to give informed consent pregnancy and breastfeeding Treatment - Drugs Treatment - Drugs Control group: Lidocaine local anesthetic 2% - Persocaine-E (lidocaine) 2% manufactured by Daroopakhsh company - each cartridge contains 1.8 ml anesthetic solution - 12.5 micrograms epinephrine - 38 mg lidocaine hydrochloride. For each patient, an anesthetic cartridge is injected in the posterior buccal of the mandible in the form of infiltration. Intervention group: Articaine local anesthetic 4%- Artheek 4% manufactured by New Stetic Company - each cartridge contains 1.8 ml anesthetic solution - 18 micrograms of epinephrine - 72 mg of articaine hydrochloride. For each patient, an anesthetic cartridge is injected in the posterior buccal of the mandible in the form of infiltration. Percentage of people who have pain during surgery. Timepoint: The presence of pain during surgery and throughout its duration. Method of measurement: Asking the patient about the presence or absence of pain. Qazvin University of Medical Sciences Approved 2023-03-18 Ethics committee of Qazvin University of Medical Sciences Bahonar Blvd Qazvin Qazvin Iran (Islamic Republic of)