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IRCT20230125057218N1 IRCT 2023-10-10 Mashhad University of Medical Sciences Comparison of anesthetic adhesive with anesthetic gel during intraoral injection Comparison of mucosal patch and gel containing benzocaine for mucosal anesthesia during needle insertion 2023-11-17 anticipated 35 Complete https://irct.ir/trial/71206 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: In this study permuted block technique randomizes patients between groups within a set of study participants, called a block. In this study, if any patient receives one of the treatments of gel (A) or patch (B) in the first intervention, he must receive the other treatment in the second intervention. Therefore, random allocation will be done only for 36 people. For this purpose, random allocation sequence of people will be used using Random Allocation Software and block size of four. So there will be 9 blocks of 4, then the list of blocks will be written and numbers will be assigned to them (AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)- BAAB) (6)) Then a number is selected between 1 and 9 (for example, 1, 4, 8, etc.) Allocation of all samples will continue. 3 Amount of pain. Intervention 1: Intervention group: Benzocaine patch is used to reduce the pain of patients during anesthesia injection. In this study, In this study a patch that adheres to the mucous membrane containing benzocaine, a product of Merc KGaA Germany, is used, which is pasted for 10 minutes in the target area before injection with a slight pressure of the finger, and not only numbs the mucous membrane, but also leaves a color that Defines the area of the anesthetized mucosa. Intervention 2: Control group: Benzocaine gel is used to reduce the pain of patients during anesthesia injection. Yes - There is a plan to make this available What will be shared: The details of the participants, such as age, sex, and the teeth studied, will be published by hiding the identity of the people. When: Access to information will be from 2025 onwards. To whom: Researchers working in academic and scientific institutions who need this information can have access . Conditions: It is not prohibited to mention the source. Where to obtain: They can refer to Mashhad Faculty of Dentistry library or Mashhad University of Medical Sciences library website. How to obtain: Information will be available in thesis format. Comments:
public Rasoul Sahebalam
Vakil Abad Blvd., Faculty of Dentistry, Department of Pediatric Dentistry
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 sahebalamr@mums.ac.ir Mashhad University of Medical Sciences scientific Rasoul Sahebalam
Vakil Abad Blvd., Faculty of Dentistry, Department of Pediatric Dentistry
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 sahebalamr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients who required two similar injection in the upper jaw bilaterally The two injections should be given within a short period of time. no limit no limit Both Mentally retarded patients Patients with systemic disease Dissatisfaction of parents or the patient himself Non-cooperative patients Other Other Intervention group: Benzocaine patch is used to reduce the pain of patients during anesthesia injection. In this study, In this study a patch that adheres to the mucous membrane containing benzocaine, a product of Merc KGaA Germany, is used, which is pasted for 10 minutes in the target area before injection with a slight pressure of the finger, and not only numbs the mucous membrane, but also leaves a color that Defines the area of the anesthetized mucosa. Control group: Benzocaine gel is used to reduce the pain of patients during anesthesia injection. Amount of pain. Timepoint: Immediately after injection. Method of measurement: SEM pain assessment index(Sounds, Eyes, Motor scale). Mashhad University of Medical Sciences Approved 2023-04-16 Ethics committee of Mashhad University of Medical Sciences,Dental Faculty Vakil Abad Blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)