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IRCT20090609002016N10 IRCT 2018-10-13 Kerman University of Medical Sciences Investigating the influence of temperature change of analgesia liquid on analgesia success The influence of Lidocaine temperature change on injection pain and analgesia success in maxillary central incisors 2018-11-08 anticipated 100 Complete https://irct.ir/trial/31517 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: In this study, the volunteers are divided into Intervention 1 or Intervention 2 groups in crosswise manner, to determine the group to which the volunteers are assigned, the table of random numbers is used to extract some numbers. Numbers 1 to 10 are written on a piece of paper and the papers are folded. Each volunteer picks a paper, the odd numbers represent intervention 1 and the even numbers represent the intervention 2. Naturally, the second time (with a two week interval) receives a different intervention from the first series, Blinding description: In this study, three persons are kept blinded to the studied groups: 1. The injector, 2. The volunteer, 3. The person who evaluates the analgesia success after injection. Blinding process of the injector: the fourth person has prepared analgesia liquids with different temperatures. These liquids are kept in syringes covered with paper wraps and are delivered to the injector so that he cannot understand the liquid temperatures. Blinding process of the analgesia success evaluator: the person who evaluates the analgesia is different with the injector. the evaluator is not informed of the injected analgesia temperature. The pain caused by the injection is graded with a visual analogue scale (VAS), pain score from zero (no pain) to ten (severe pain) which is reported to evaluator by volunteer. Blinding process of the volunteer: before the study, the volunteer is informed of the nature of the study, his blindness during the study, and his questions are answered. Each volunteer randomly picks a paper between 1 to 10 the odd numbers represent intervention 1 and the even numbers represent the intervention 2. The volunteers does not know the temperature of the analgesia liquid and their groups. 2-3 Anesthesia injection pain. Intervention 1: Intervention group1: Injection single dose of Lidocaine 2% with Epinephrine 1:80000 (Iran, Tehran, Darupakhsh) at 37 C temperature to 50 volunteer. Intervention 2: Intervention group 2: Injection single dose of Lidocaine 2% with Epinephrine 1:80000 (Iran, Tehran, Darupakhsh) at room temperature to 50 volunteer. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Masoud Parirokh
School of Dentistry, Shafa Street
Kerman Iran (Islamic Republic of) 7618759689 +98 342118074 m_parirokh@kmu.ac.ir Kerman University of Medical Sciences scientific Masoud Parirokh
Headquarter Builidng of Kerman Medical Sciences University, Jomhori Eslami Bloubvared
Kerman Iran (Islamic Republic of) 7618759689 +98 34 1245 7931 m_parirokh@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Age more than 18 years No consumption of analgesic and antidepressant medications during recent 48 hours No contraindications or sensitivity for injecting lidocaine with epinephrine Having no systemic disease 18 years no limit Both No response to the cold test Having sensitivity to percussion Having sensitivity to palpation Previous history of root canal therapy Internal or external resorption Treatment - Other Treatment - Other Intervention group1: Injection single dose of Lidocaine 2% with Epinephrine 1:80000 (Iran, Tehran, Darupakhsh) at 37 C temperature to 50 volunteer Intervention group 2: Injection single dose of Lidocaine 2% with Epinephrine 1:80000 (Iran, Tehran, Darupakhsh) at room temperature to 50 volunteer Pain during injection. Timepoint: At the time of local anesthetic injection. Method of measurement: Using visual analoug scale (VAS). Success rate of anesthetic depth. Timepoint: After injection of local anesthesia. Method of measurement: Pulp tester. Kerman University of Medical Sciences Approved 2018-02-26 The Ethic Committee of Kerman University of Medical Sciences Vice-chancellor for Research, Building of Kerman University of Medical Sciences, Tahmaseb-abad cross, Jahad Street Kerman Kerman Iran (Islamic Republic of)