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IRCT20131205015665N8 IRCT 2025-09-05 Esfahan University of Medical Sciences Evaluation of palatal mucosa anesthesia due to infiltration of lidocaine compared to articaine Evaluation of palatal mucosa anesthesia due to infiltration of lidocaine compared to articaine in the buccal region of maxilla 2025-09-06 anticipated 34 Complete https://irct.ir/trial/85303 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Blinding description: anesthesia during maxillary dental procedures. The study will be conducted as a randomized, double-blind, crossover clinical trial at the School of Dentistry, Isfahan University of Medical Sciences, Iran. Participants will be candidates for bilateral maxillary implant placement, with both sides scheduled for surgery in a single session, as performing bilateral maxillary implant surgery in one session is a common practice. During the session, buccal injections of both anesthetic agents (articaine and lidocaine) will be administered with an appropriate washout period to ensure that the effect of the first anesthetic is eliminated. Injections will be performed in the buccal region of the maxillary canine and first molar on both sides, and participants will be blinded to the type of anesthetic used. Considering that systemic conditions and pain thresholds may vary between treatment sessions, both sides will be evaluated within the same session while observing the washout period. A computerized injection device will be used to standardize the injection rate. Randomization will be performed and managed using an online software. For operator blinding, anesthetic cartridges will be color-coded (e.g., blue and red) so that the operator is unaware of the type of anesthetic. Prior to each injection, and after drying the buccal mucosa of the maxillary canine and first molar, a lidocaine gel will be applied to the site for one minute using an applicator. 3 Comparative evaluation of the effectiveness of articaine and lidocaine for achieving palatal anesthesia.. Intervention 1: Intervention group: Participants are randomly assigned to receive articaine anesthesia on one side of the maxilla (left or right) which half a cartridge (equivalent to 0.9 mL) was injected at the canine region and the same amount at the first maxillary molar region using the infiltration technique. Intervention 2: Control group: Participants randomly receive lidocaine on the contralateral side of the maxilla (e.g., the left side if articaine was administered on the right) which half a cartridge (equivalent to 0.9 mL) was injected at the canine region and the same amount at the first maxillary molar region using the infiltration technique. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: Access period starts 6 months after results are published To whom: Only for researchers working in academic and scientific institutions Conditions: .No other condition Where to obtain: Address: Faculty of Dentistry, Isfahan University of Medical Sciences, Tel: 03137925521 How to obtain: .10 day after sending the request,data will be accessible Comments:
public Dr. Milad Etemadi
Hezar Jarib
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5521 etemadi@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Milad Etemadi
Hezar Jarib
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5521 etemdi@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) All people who are candidates for implants on both sides of the maxilla 18 years no limit Both Age less than 18 years History of trauma or nasal surgery History of psychiatric disorder Congenital anomalies Peripheral neuropathy or presence of sensory deficits in the facial area prior to surgery Uncontrolled systemic conditions Treatment - Drugs Treatment - Drugs Intervention group: Participants are randomly assigned to receive articaine anesthesia on one side of the maxilla (left or right) which half a cartridge (equivalent to 0.9 mL) was injected at the canine region and the same amount at the first maxillary molar region using the infiltration technique. Control group: Participants randomly receive lidocaine on the contralateral side of the maxilla (e.g., the left side if articaine was administered on the right) which half a cartridge (equivalent to 0.9 mL) was injected at the canine region and the same amount at the first maxillary molar region using the infiltration technique. The amount of change in pain threshold. Timepoint: Before and 5 minutes after injection. Method of measurement: Light Touch (Semmes Weinstein monofilament) test. The amount of change in sensory threshold. Timepoint: Before and 5 minutes after injection. Method of measurement: Light Touch (Semmes Weinstein monofilament) test. Esfahan University of Medical Sciences Approved 2025-07-26 Ethics Committee of Isfahan University of Medical Sciences Hezar Jerib Street Isfahan Isfehan Iran (Islamic Republic of)