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IRCT20210720051947N1 IRCT 2021-08-22 Boushehr University of Medical Sciences Comparison of two needle tip designs ,Sebtoject and NOP on pain perception during injections Comparison of two needle tip designs, Sebtoject and NOP, on pain perception during inferior alveolar nerve block injections in 6 to 8 years old children 2021-08-01 anticipated 30 Complete https://irct.ir/trial/57638 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: This study is two period cross over clinical trail. Based on this study the patients were presented in 2 frequency, 2 periods and 2 symbols, BA & AB. In AB group, the first period ( A intervention) received septoject intervention and the second one (B intervention) received NOP intervention. But in BA group right inverse the former, we observe in the first period NOP intervention and in the second one septoject intervention for injecting the analgesia medicine. The population of this study in the first period, randomly were divided in 2 equal groups and for this purpose we used of permuted block randomization method. The permuted block randomization was downloaded from http://randomization.com freely, Blinding description: The population of the study randomly was divided in 2 equal group, A & B. Group A in the first visit received septoject needle and in the second one, NOP needle for injecting the analgesia medicine. Group B right inverse, patients in the first visit received NOP needle and in the second section, septoject for injecting the analgesia medicine ( cross design A&B). It is better to mention that just the dentist knows the order of permuted block randomization and participants' arrival; so evaluator should not observe the kind of intervention and the scale of block. We can say that attribution of data will be hidden until the end of study. N/A Inferior alveolar nerve block injections. Intervention 1: Intervention group: the group of patients that receive NOP. This needle is made in South Korea and because of silicone cover beside trihedral needle's top, cause less bleeding and trauma or even eliminate it during injection. Intervention 2: Control group: the group receive sebtoject 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 more information
public Sima Jokar
Bushehr University of Medical Sciences., Bushehr ., bushehr province
Bushehr Iran (Islamic Republic of) 7518759577 +98 77 3332 3226 s.jokar@bpums.ac.ir Boushehr University of Medical Sciences scientific Sima Jokar
Bushehr University of Medical Sciences., Bushehr ., bushehr province
Bushehr Iran (Islamic Republic of) 7518759577 +98 77 3332 3226 s.jokar@bpums.ac.ir Boushehr University of Medical Sciences Iran (Islamic Republic of) Informing parents and gaining informed consent to participate in the study Children are 6 to 8 years old The patient has two stages of treatment (visit twice) 6 years 8 years Both Withdrawal from the study History of allergy to anesthetic solution or contraindication to anesthesia History of systemic diseases or special conditions that endanger public health Taking painkillers in the last two months Treatment - Devices N/A Intervention group: the group of patients that receive NOP. This needle is made in South Korea and because of silicone cover beside trihedral needle's top, cause less bleeding and trauma or even eliminate it during injection. Control group: the group receive sebtoject needle. Pain intensity score. Timepoint: Measurements immediately after the first and second injections. Method of measurement: 1: Face criterion 2: Objective evaluation with SEM scale. Boushehr University of Medical Sciences Approved 2021-03-07 Ethics committee of Bushehr University of Medical Sciences Rishehr, Bandar Bushehr, Bushehr province Bushehr Boushehr Iran (Islamic Republic of)