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IRCT20191015045116N1 IRCT 2020-04-12 Tehran University of Medical Sciences Comparison of the efficacy of non-needle and needle anesthesia (common dental anesthesia) Efficacy and acceptance of a new local anesthesia technique (needleless injection) with the conventional technique in the management of maxillary deciduous teeth 2020-03-15 anticipated 25 Complete https://irct.ir/trial/45694 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization process in this study is a quadruple block design. In this way, we have four modes for intervention, including the left maxillary anesthesia needle / left maxillary anesthesia needle / right maxilla anesthesia needleless needle / right maxilla anesthesia needle needle. These four options are placed in separate envelopes in a package and placed in the first session of the intervention in front of the child and are randomly selected by the child and given to the practitioner and the intervention is performed. The second session is on the opposite side and the second method is done, Blinding description: In this study the supervisor does the injection and during the injection the FLACC questionnaire is filled by the secretary who has no information about the dental work and the type of anesthesia, so this person is blind. Also, the student doing the restoration work (which is the same student working on this thesis) will be blind because he does not know in what way the child is numb. N/A Efficacy and acceptance of a new local anesthesia technique (needleless injection). Intervention 1: Intervention group: Intervention group is a group that is anesthetized with a needleless anesthesia. In this method, a compression anesthesia device called Madajet is used, which does not have a needle and can be sterilized. Milk Spray, which each time sprays 0.1 ml of anesthetic into a small area of ​​tissue (the only area we want to anesthetize), which is lent to a needle because of its jet depth. Anesthesia is injected at three points: the mesococcal / distal buccal and palatal. Intervention 2: Control group: Control group: There are groups that are anesthetized with the usual anesthetic. The usual injection of anesthesia with a needle is as follows: The anesthetic is injected with a sterile syringe and the needle (which is available in different gauges) is injected deep into the vestibule. Lidocaine anesthesia is 2% and epinephrine is 1 in 80,000 for the drug distribution company. Yes - There is a plan to make this available What will be shared: All potential data is shared after unidentifiable people. When: Start of access period from 1399 To whom: All applicants Conditions: Can be used in all situations. Where to obtain: Tehran University of Medical Sciences How to obtain: There is no specific process. Comments:
public Ghazaleh Baniebrahimi
Complex Golchin Laleh 60 Ave Laleh Alley Aqdessia South Golchin
tehran Iran (Islamic Republic of) 1696617814 +98 21 2248 8305 ghazalebaniebrahimi@gmail.com Tehran University of Medical Sciences scientific Ghazaleh Baniebrahimi
Golchin Laleh complex 60 Ave Laleh Alley South Golchin Aqdessia
tehran Iran (Islamic Republic of) 1696617814 +98 21 2248 8305 ghazalebaniebrahimi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Children aged 6 to 12 years. These children have decayed primary molar on both sides of the maxilla. These decayed primary molars require restorative treatment. The repair of these decayed primary molars requires anesthesia. 6 years 12 years Both children who are so uncooperative that the university refuses to accept them. Children who have any systemic or infectious or viral diseases. Treatment - Devices Treatment - Devices Intervention group: Intervention group is a group that is anesthetized with a needleless anesthesia. In this method, a compression anesthesia device called Madajet is used, which does not have a needle and can be sterilized. Milk Spray, which each time sprays 0.1 ml of anesthetic into a small area of ​​tissue (the only area we want to anesthetize), which is lent to a needle because of its jet depth. Anesthesia is injected at three points: the mesococcal / distal buccal and palatal. Control group: Control group: There are groups that are anesthetized with the usual anesthetic. The usual injection of anesthesia with a needle is as follows: The anesthetic is injected with a sterile syringe and the needle (which is available in different gauges) is injected deep into the vestibule. Lidocaine anesthesia is 2% and epinephrine is 1 in 80,000 for the drug distribution company. The pain and discomfort questionnaire (FLACC) is rated as 3 (0 1 2) as to whether the condition (face / legs / child activity / crying during injection and child sympathy). Timepoint: The FLACC questionnaire is filled in at the time of anesthesia injection and during the regenerative treatment. Method of measurement: The pain and discomfort questionnaire (FLACC) is rated as 3 (0 1 2) as to whether the condition (face / legs / child activity / crying during injection and child sympathy). Tehran University of Medical Sciences Approved 2019-07-29 Ethics Committee of the Faculty of Dentistry, University of Tehran Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. tehran Tehran Iran (Islamic Republic of)