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IRCT20170101031697N5 IRCT 2021-01-07 Bandare-abbas University of Medical Sciences Comparison of the effect of articaine infiltrated anesthesia with lidocaine block anesthesia in the treatment of mandibular second molar palpotomy Comparison of the anesthetic efficacy of Articaine infiltration versus lidocaine inferior alveolar nerve block in pulp therapy of lower second primary molars 2020-12-26 anticipated 76 Complete https://irct.ir/trial/53246 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: In this study, randomization of participants as an individual unit and simple randomization, which will be divided into two equal groups based on the random division command in SPSS software, Blinding description: Participant: The participant's blindness is such that before injecting anesthesia, the person is asked to open his mouth, at which time the injector waits for a minute and then injects. This causes the patient not to notice the injection. Impact Assessor: The outcome assessor will not be aware of the type of injection when evaluating the patient. 2-3 Local anesthesia. Intervention 1: Intervention group: the first session of lidocaine infraalveolar nerve block injection and the second session of articaine infiltration injection. In this group, in order to pulpotomy of second primary mandibular molar in one session, after preparing radiography and performing the initial steps for treatment, infra alveolar nerve block injection using carpol lidocaine 2% with epinephrine 1: 100000, for a child at one minute will be done. After the appropriate time (10 minutes) and ensuring complete anesthesia by using the lip anesthesia index, we begin the process of removing the caries and preparing the access cavity, and the child's reaction will be measured at the moment of pulp exposure. Before the test, we explain the VAS (Visual Analogue Scale) diagram and how to show the amount of discomfort on it to the child and immediately ask the child during the cutting of the cavity in the dentin or in cases of pulp treatment at the moment of pulp exposure to mark the appropriate face on the VAS chart, depending on the amount of pain or discomfort. The same child will be treated for the pulpotomy of second primary mandibular molar in opposite side in the next session, one week after the first session. After preparing the radiography and performing the initial steps for treatment, infiltration injection in the vicinity of the target tooth using carpool articaine 4% with epinephrine 1: 100000, will be performed for the child in one minute. After the appropriate time (10 minutes) and ensuring complete anesthesia by using the lip anesthesia index, we begin the process of caries removal and preparation of the access cavity, and the child's reaction will be measured at the moment of pulp exposure. Explain the Visual Analogue Scale and how to display the amount of discomfort on it to the child and immediately when cutting the cavity in the dentin or in cases of need for pulp treatment at the moment of pulp exposure, we ask the child to mark the appropriate face on the VAS chart, depending on the amount of pain or discomfort. Intervention 2: Intervention group: The first session of articaine infiltration injection and the second session of lidocaine infra alveolar nerve block injection. In this group, in order to pulpotomy of second primary mandibular molar in one session, after preparing radiography and performing the initial steps for treatment, infiltration injection in the vicinity of the target tooth using 4% carpool articaine with 1: 100000 epinephrine, for the child It will be done in one minute. After the appropriate time (10 minutes) and ensuring complete anesthesia by using the lip anesthesia index, we begin the process of removing the caries and preparing the access cavity, and the child's reaction will be measured at the moment of pulp exposure. Before the test, we explain the VAS (Visual Analogue Scale) diagram and how to show the amount of discomfort on it to the child and immediately ask the child during the cutting of the cavity in the dentin or in cases of pulp treatment at the moment of pulp exposure to mark the appropriate face on the VAS chart, depending on the amount of pain or discomfort, and the same child will be treated for the opposite side of the mandible in the next session, one week after the first session. After preparing radiography and performing the initial steps for treatment, infra alveolar nerve block injection using carpol lidocaine 2% with epinephrine 1: 100000, for a child at one minute will be done. After the appropriate time (10 minutes) and ensuring complete anesthesia by using the lip anesthesia index, we begin the process of removing the caries and preparing the access cavity, and the child's reaction will be measured at the moment of pulp exposure. Before the test, we explain the VAS (Visual Analogue Scale) diagram and how to show the amount of discomfort on it to the child and immediately ask the child during the cutting of the cavity in the dentin or in cases of pulp treatment at the moment of pulp exposure to mark the appropriate face on the VAS chart, depending on the amount of pain or discomfort. Yes - There is a plan to make this available What will be shared: The information obtained from this study can be shared without the ability to identify participants. When: From October 2021 To whom: Researchers and referees Conditions: Obtaining a written permit and mentioning the name in the sources and references Where to obtain: Sara Bakhshaei saraesmaili43@gmail.com How to obtain: The request must first be emailed and answered after review and approval. Comments:
public Sara Esmaeili
Dental Clinic of Bandar Abbas School of Dentistry, Shahid Naser St, Imam Khomeini Blvd
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3334 5009 saraesmaili43@gmail.com Bandare-abbas University of Medical Sciences scientific Sara Esmaeili
Dental Clinic of Bandar Abbas School of Dentistry, Shahid Naser St, Imam Khomeini Blvd
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3334 5009 saraesmaili43@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Healthy children four to ten years old who need treatment for the pulp molars of the mandible on both sides. 4 years 10 years Both Children who have any sores or mucosal lesions during treatment sessions in the buccal vestibule. Y48.3 Local anaesthetics Treatment - Drugs Treatment - Drugs Intervention group: the first session of lidocaine infraalveolar nerve block injection and the second session of articaine infiltration injection. In this group, in order to pulpotomy of second primary mandibular molar in one session, after preparing radiography and performing the initial steps for treatment, infra alveolar nerve block injection using carpol lidocaine 2% with epinephrine 1: 100000, for a child at one minute will be done. After the appropriate time (10 minutes) and ensuring complete anesthesia by using the lip anesthesia index, we begin the process of removing the caries and preparing the access cavity, and the child's reaction will be measured at the moment of pulp exposure. Before the test, we explain the VAS (Visual Analogue Scale) diagram and how to show the amount of discomfort on it to the child and immediately ask the child during the cutting of the cavity in the dentin or in cases of pulp treatment at the moment of pulp exposure to mark the appropriate face on the VAS chart, depending on the amount of pain or discomfort. The same child will be treated for the pulpotomy of second primary mandibular molar in opposite side in the next session, one week after the first session. After preparing the radiography and performing the initial steps for treatment, infiltration injection in the vicinity of the target tooth using carpool articaine 4% with epinephrine 1: 100000, will be performed for the child in one minute. After the appropriate time (10 minutes) and ensuring complete anesthesia by using the lip anesthesia index, we begin the process of caries removal and preparation of the access cavity, and the child's reaction will be measured at the moment of pulp exposure. Explain the Visual Analogue Scale and how to display the amount of discomfort on it to the child and immediately when cutting the cavity in the dentin or in cases of need for pulp treatment at the moment of pulp exposure, we ask the child to mark the appropriate face on the VAS chart, depending on the amount of pain or discomfort. Intervention group: The first session of articaine infiltration injection and the second session of lidocaine infra alveolar nerve block injection. In this group, in order to pulpotomy of second primary mandibular molar in one session, after preparing radiography and performing the initial steps for treatment, infiltration injection in the vicinity of the target tooth using 4% carpool articaine with 1: 100000 epinephrine, for the child It will be done in one minute. After the appropriate time (10 minutes) and ensuring complete anesthesia by using the lip anesthesia index, we begin the process of removing the caries and preparing the access cavity, and the child's reaction will be measured at the moment of pulp exposure. Before the test, we explain the VAS (Visual Analogue Scale) diagram and how to show the amount of discomfort on it to the child and immediately ask the child during the cutting of the cavity in the dentin or in cases of pulp treatment at the moment of pulp exposure to mark the appropriate face on the VAS chart, depending on the amount of pain or discomfort, and the same child will be treated for the opposite side of the mandible in the next session, one week after the first session. After preparing radiography and performing the initial steps for treatment, infra alveolar nerve block injection using carpol lidocaine 2% with epinephrine 1: 100000, for a child at one minute will be done. After the appropriate time (10 minutes) and ensuring complete anesthesia by using the lip anesthesia index, we begin the process of removing the caries and preparing the access cavity, and the child's reaction will be measured at the moment of pulp exposure. Before the test, we explain the VAS (Visual Analogue Scale) diagram and how to show the amount of discomfort on it to the child and immediately ask the child during the cutting of the cavity in the dentin or in cases of pulp treatment at the moment of pulp exposure to mark the appropriate face on the VAS chart, depending on the amount of pain or discomfort. Pain when exposing the pulp. Timepoint: When exposing the pulp. Method of measurement: Using the Visual Analogue Scale chart. Pain during injection start. Timepoint: During injection start. Method of measurement: Using the Visual Analogue Scale chart. Bandare-abbas University of Medical Sciences Approved 2020-12-23 Ethics Committee of Bandar Abbas University of Medical Sciences Ethics Committee of Bandar Abbas University of Medical Sciences,Research Deputy Building, Shahid Mohammadi Hospital, Jomhoori Islami Blvd. Bandar Abbas Hormozgan Iran (Islamic Republic of)