]>
IRCT20171020036896N9 IRCT 2021-06-05 Kerman University of Medical Sciences Clinical success and pain of two anesthetics methods of Inferior Alveolar Nerve Block and crestal anesthesia and two anesthetics materials of lidocaine and articaine in the crestal anesthesia for pulpotomy treatment of primary molars Comparison of two anesthetics methods of Inferior Alveolar Nerve Block and crestal anesthesia and two anesthetics materials of lidocaine and articaine in the crestal anesthesia for pulpotomy treatment of primary molars 2021-04-20 anticipated 90 Complete https://irct.ir/trial/54287 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the simple randomization method (flip the coin) will be used. In such a way that one of the study groups will be considered as heads and the other group will be considered as tails. Then the same number of coins will be thrown based on the sample size. Finally, to prevent disclosure of random sequencing, the allocation concealment will be used, Blinding description: The patient is not aware of local anesthetic agent and technique at the time of treatment. Statistics consultant is not aware of local anesthetic agent and technique at the time of treatment too. 2 Condition 1: The comparison of effect of inferior alveolar nerve block and crestal local anesthesiain in pulpotomy of primary teeth. Condition 2: The effect of crestal local anesthesia using lidocaine in pulpotomy of primary teeth. Condition 3: The effect of crestal local anesthesia using articaine in pulpotomy of primary teeth. Intervention 1: Intervention group 1: In this group, in the first session, pulpotomy of a mandibular primary molar will be performed by injecting inferior alveolar nerve block using lidocaine 2% with epinephrine 1: 100,000 (produced by Iran Pharmaceutical Company) and in the second session, pulpotomy of a primary molar will be performed on the other side of the mandible by crestal local injection using lidocaine 2% with epinephrine 1: 100000 (produced by Iran Pharmaceutical Company). Before and after the local anesthetic injection, changes in the child's pulse is measured using a pulse oximeter in both sessions. After an appropriate time (10 minutes) to determine the time of onset of anesthesia, IANB anesthesia is tested with a catheter after the child's lip feels numb, and CA anesthesia is tested immediately after injection into the second papilla. Then the caries removal process and preparation of the access cavity begin and the child's reaction is measured at the moment of pulp exposure. Before the treatment, the assistant will explain the Visual Analogue Scale (VAS) to the child and how to display the amount of discomfort on it, and immediately while preparing the access cavity in dentin or in case of need for pulp treatment at the time of pulp exposure. The child is asked to rate one of the smileys from zero (painless) to 10 (unbearable pain) based on the intensity of the pain he feels. The result is then recorded on the child form. Intervention 2: Intervention group 2: In this group, in the first session, pulpotomy of a mandibular primary molar will be performed by crestal local injection using lidocaine 2% with epinephrine 1: 100,000 (produced by Iran Pharmaceutical Company) and in the second session, pulpotomy of a primary molar will be performed on the other side of the mandible by crestal local injection using articaine 4% with epinephrine 1: 100000 (produced by Iran Pharmaceutical Company). Before and after the local anesthetic injection, changes in the child's pulse is measured using a pulse oximeter in both sessions. To determine the time of onset of anesthesia, CA anesthesia is tested immediately after injection into the second papilla. Then the caries removal process and preparation of the access cavity begin and the child's reaction is measured at the moment of pulp exposure. Before the treatment, the assistant will explain the Visual Analogue Scale (VAS) to the child and how to display the amount of discomfort on it, and immediately while preparing the access cavity in dentin or in case of need for pulp treatment at the time of pulp exposure. The child is asked to rate one of the smileys from zero (painless) to 10 (unbearable pain) based on the intensity of the pain he feels. The result is then recorded on the child form. 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 Because what you have read is in addition to analyzing additional scientific application
public Parisa Jafari
Shafa Ave
Kerman Iran (Islamic Republic of) 7618759689 +98 34 8074 3211 Parisajafaridnt@gmail.com Kerman University of Medical Sciences scientific Parisa Jafari
Shafa Ave
Kerman Iran (Islamic Republic of) 7618759689 +98 34 8074 3211 Parisajafaridnt@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Children who need a bilateral pulpotomy of deciduous molars (D or E) in the mandible based on clinical signs and radiography and at the diagnosis of a pediatric dentist. Age category 4 to 8 years Parents' consent to participate in the study 4 years 8 years Both Having a history of systemic disease Having severe fear and anxiety Using painkillers to control toothache Having acute dental infections Having deciduous molars that have more than two thirds of their roots analyzed Treatment - Drugs Treatment - Drugs Intervention group 1: In this group, in the first session, pulpotomy of a mandibular primary molar will be performed by injecting inferior alveolar nerve block using lidocaine 2% with epinephrine 1: 100,000 (produced by Iran Pharmaceutical Company) and in the second session, pulpotomy of a primary molar will be performed on the other side of the mandible by crestal local injection using lidocaine 2% with epinephrine 1: 100000 (produced by Iran Pharmaceutical Company). Before and after the local anesthetic injection, changes in the child's pulse is measured using a pulse oximeter in both sessions. After an appropriate time (10 minutes) to determine the time of onset of anesthesia, IANB anesthesia is tested with a catheter after the child's lip feels numb, and CA anesthesia is tested immediately after injection into the second papilla. Then the caries removal process and preparation of the access cavity begin and the child's reaction is measured at the moment of pulp exposure. Before the treatment, the assistant will explain the Visual Analogue Scale (VAS) to the child and how to display the amount of discomfort on it, and immediately while preparing the access cavity in dentin or in case of need for pulp treatment at the time of pulp exposure. The child is asked to rate one of the smileys from zero (painless) to 10 (unbearable pain) based on the intensity of the pain he feels. The result is then recorded on the child form. Intervention group 2: In this group, in the first session, pulpotomy of a mandibular primary molar will be performed by crestal local injection using lidocaine 2% with epinephrine 1: 100,000 (produced by Iran Pharmaceutical Company) and in the second session, pulpotomy of a primary molar will be performed on the other side of the mandible by crestal local injection using articaine 4% with epinephrine 1: 100000 (produced by Iran Pharmaceutical Company). Before and after the local anesthetic injection, changes in the child's pulse is measured using a pulse oximeter in both sessions. To determine the time of onset of anesthesia, CA anesthesia is tested immediately after injection into the second papilla. Then the caries removal process and preparation of the access cavity begin and the child's reaction is measured at the moment of pulp exposure. Before the treatment, the assistant will explain the Visual Analogue Scale (VAS) to the child and how to display the amount of discomfort on it, and immediately while preparing the access cavity in dentin or in case of need for pulp treatment at the time of pulp exposure. The child is asked to rate one of the smileys from zero (painless) to 10 (unbearable pain) based on the intensity of the pain he feels. The result is then recorded on the child form. Pain. Timepoint: Immediately after the crestal injection, the child's pain is measured by the VAS (Visual Analogue Scale) during the opening of the dental pulp. Method of measurement: The child's pain is measured by the VAS (Visual Analogue Scale). Changes in the heart rate to determine the amount of pain experienced by the child during the crestal injection. Timepoint: Changes in a child's heart rate are made by using a pulse oximeter 5 seconds before and immediately after the local anesthetic injection. Method of measurement: Changes in a child's heart rate are made by using a pulse oximeter 5 seconds before and immediately after the local anesthetic injection. Kerman University of Medical Sciences Approved 2021-03-01 Ethics Committee of Kerman University of Medical Sciences shafa street kerman Kerman Iran (Islamic Republic of)