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IRCT20200301046656N1 IRCT 2021-01-21 Shahid Beheshti University of Medical Sciences Anesthetic Efficacy of Modified Infiltration Technique in mandibular molars Primary and Supplementary Anesthetic Efficacy of Modified Infiltration Technique with 4% Articaine versus Inferior Alveolar Nerve Block with 2% lidocaine in Mandibular molars with Irreversible Pulpitis: A Randomized Clinical Trial 2021-01-31 anticipated 84 Complete https://irct.ir/trial/53111 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization table will be provided by the statistician. The permuted block randomization method will be used for randomizing the participants. In each block, randomization sequences will be generated using Microsoft Excel software. The statistician will be blinded to the study's aims and methods of injections, Blinding description: The investigator will leave the treatment room after evaluating the inclusion and exclusion criteria. Then, the practitioner will carry out the injection after opening the allocated opaque and sealed envelope just before the injection. afterward, the practitioner will use a rubber dam to blind the investigator and tell the investigator to come back to the treatment room and collect the required information. The code on the envelopes, that distinguishes the type of injection using the randomization sequence, will be recorded in the patients' profiles. The investigator will be blinded to the type of injection. Due to the different methods of the two injections, completely blinding the practitioner and patients will not be applicable. The statistician will be blinded to the aims and steps of the present study. 3 Irreversible pulpitis. Intervention 1: Intervention group: Subperiosteal group. In this group, patients will receive an anesthetic subperiosteal injection of 1.8 mL articaine 4% with 1:100.000 epinephrine with an extra short 27-gauge needle. This injection will be carried out in both the mesial and distal parts. Intervention 2: Control group: Inferior alveolar nerve block group. In this group, patients will receive an inferior alveolar nerve block with 1.8 mL lidocaine 2% with 1:100.000 epinephrine using a long 27-gauge needle. Intervention 3: Supplementary modified infiltration technique group: in this group, patients will receive an Inferior alveolar nerve block anesthesia, and after the numbness of the lower lip, they will receive a subperiosteal injection of 1.8 mL 4% articaine with 1:100.000 epinephrine, with a 27-gauge, extra short needle. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Nazanin Zargar
Dental school, Shahid Beheshti University of Medical Sciences, Daneshjou Blvd., Evin Ave, Shahid Chamran Highway, Tehran, Iran.
tehran Iran (Islamic Republic of) 1983963113 +98 21 2217 5350 nzargar48@gmail.com Shahid Beheshti University of Medical Sciences scientific Nazanin Zargar
Dental school, Shahid Beheshti University of Medical Sciences, Daneshjou Blvd., Evin Ave, Shahid Chamran Highway, Tehran, Iran.
tehran Iran (Islamic Republic of) 1983963113 +98 21 2217 5350 nzargar48@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) having a first/second mandibular molar tooth diagnosed with irreversible pulpitis absence of any systemic disease absence pregnancy or nursing for female participants occurrence of periapical lesion on preoperative radiograph(s) absence of any inflammation or lesion/wound in anesthetic injection's area absence of a history of any allergic reaction to the materials used in the present study 18 years 65 years Both more than 0.5 mm mobility on occluso-gingival and/or bucco-lingual and/or mesio-distal direction. taking analgesic medications less than a day before the beginning of the treatment absence of vital pulpal tissue upon access cavity preparation K04.02 Irreversible pulpitis Treatment - Other Treatment - Other Treatment - Other Intervention group: Subperiosteal group. In this group, patients will receive an anesthetic subperiosteal injection of 1.8 mL articaine 4% with 1:100.000 epinephrine with an extra short 27-gauge needle. This injection will be carried out in both the mesial and distal parts. Control group: Inferior alveolar nerve block group. In this group, patients will receive an inferior alveolar nerve block with 1.8 mL lidocaine 2% with 1:100.000 epinephrine using a long 27-gauge needle. Supplementary modified infiltration technique group: in this group, patients will receive an Inferior alveolar nerve block anesthesia, and after the numbness of the lower lip, they will receive a subperiosteal injection of 1.8 mL 4% articaine with 1:100.000 epinephrine, with a 27-gauge, extra short needle. Patient's perceived pain score. Timepoint: before the injection, while injecting, access cavity preparation, and initial filing. Method of measurement: 170 mm Heft Parker Visual anlogue scale. Shahid Beheshti University of Medical Sciences Approved 2020-01-28 the Ethics Committee of Shahid Beheshti University of Medical Sciences the Ethics Committee of Shahid Beheshti University of Medical Sciences, Evin, Tehran. tehran Tehran Iran (Islamic Republic of)