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IRCT20190702044078N1 IRCT 2020-05-23 Arak University of Medical Sciences Effect of Needle Gauge on Pain and Anxiety During Dental Anesthesia Comparison of the Effect of Needle Gauge on Pain and Anxiety of Children During Palatal Infiltration Anesthesia 2019-11-22 anticipated 60 Complete https://irct.ir/trial/40543 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: Randomization method: Simple Randomization Unit: Individual Randomization tool: To place the subjects in two groups based on the needle gauge priority in the injection of anesthesia using SPSS software version 16 and to select the maxillary quadrant in the third session of 60 completely identical envelopes with half of them zero And in half number one is used. During the first treatment session, the envelope will be moved, then a envelope will be selected for each child. If the number is zero the treatment is on the right and if the number is one the treatment is on the left. Hiding is done by uniform and black envelopes, Blinding description: The present study is a double-blind study because the patient and the dentist assistant (questionnaire information recorder) are unaware of how individuals are assigned to groups and the type of intervention performed at each session to treat individuals(use 27 or 30 gauge needle). N/A . Intervention 1: Intervention group: Anesthesia injection of palatal infiltration with gauge 30 needle. Anesthetizing agent used for all patients is Lidocaine 2% E_80, Daroupakhsh, that with C-Kject needle by conventional infiltration of palatal with ICT injection device of the Genoss company at 0.2 ml will be injected. Intervention 2: Intervention group: Intervention group: Anesthesia injection of palatal infiltration with gauge 27 needle. Anesthetizing agent used for all patients is Lidocaine 2% E_80, Daroupakhsh, that with C-Kject needle by conventional infiltration of palatal with ICT injection device of the Genoss company at 0.2 ml will be injected. Yes - There is a plan to make this available What will be shared: All data are publishable. When: One year after publishing results To whom: All researcher in university and research centers Conditions: There are no conditions Where to obtain: Dr Hamid Sarlak How to obtain: Request a person by email Investigating university affiliation of the requesting person send information via email the maximum time of this process is one month Comments:
public Hamid Sarlak
Fifth Floor, Mir Ahmad Building, Azod Corner, Shahid Beheshti Street
Arak Iran (Islamic Republic of) 3813634159 +98 86 3222 3794 Dr.hamidsarlak@yahoo.com Arak University of Medical Sciences scientific Zohre Salimi
Narges Hostel, Basij Square, Sardasht
Arak Iran (Islamic Republic of) 3819693345 +98 26 3272 1601 zohre.salizs@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) All patients should be candidates for double-sided pulpotomy and stainless steel crown (SSC) in the first or second primary maxillary molars of the same type They are genetically, systemic and able to learn healthy They have no history of dental treatment and hospitalization In Frankel cooperation scale should be in positive or definitely positive position 4 years 8 years Both Existence of severe pain or obvious need for treatment on a side earlier of opposite side that excludes the study from a random state Prevention Prevention Intervention group: Anesthesia injection of palatal infiltration with gauge 30 needle. Anesthetizing agent used for all patients is Lidocaine 2% E_80, Daroupakhsh, that with C-Kject needle by conventional infiltration of palatal with ICT injection device of the Genoss company at 0.2 ml will be injected. Intervention group: Intervention group: Anesthesia injection of palatal infiltration with gauge 27 needle. Anesthetizing agent used for all patients is Lidocaine 2% E_80, Daroupakhsh, that with C-Kject needle by conventional infiltration of palatal with ICT injection device of the Genoss company at 0.2 ml will be injected. Pulse rate. Timepoint: Heart rate at each treatment session (third and fourth sessions) is measured three times and recorded by the dentist's assistant: 1. After sitting the child on the unit (one minute before injection) 2. 10 seconds after local anesthetic injection 3. During the pulp exposure. Method of measurement: To test the heart rate, the digital electronical device OXY300 (Microlife AG, Widnau, Switzerland) will be used by placing the probe on the child's left hand finger. Face pain rating. Timepoint: After injection of anesthesia. Method of measurement: The subjective evaluation of pain is performed by the FPR scale after the injection of an anesthesia drug, which is recorded by the child using its scoring image, and determined score by the next session in the presence of another gauge are compared. Evaluation of pain by eye, movement and sound (SEM). Timepoint: During injection of anesthesia. Method of measurement: The Objective scale used to measure pain is the SEM scale that evaluates the sound, eyes, and movements of the child according to the score table. The score is measured and recorded by the dentist's assistant during injection of anesthesia with a needle gauge and at the next meeting with another gauge and will be compared. Arak University of Medical Sciences Approved 2019-08-04 Ethics committee of Arak university of medical sciences Academic complex of the Great prophet, Basij squre, Sardasht Arak Markazi Iran (Islamic Republic of)