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IRCT20210914052474N2 IRCT 2023-01-04 Shahid Beheshti University of Medical Sciences the effect low level laser on reversing the effect of inferior alveolar nerve block Evaluation of the effect of 808 nm low level laser on reversing the effect of inferior alveolar nerve block in 6-9 years old children 2023-02-20 anticipated 34 Complete https://irct.ir/trial/67732 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study was conducted in a split-mouth manner, and sealed envelopes were used for randomization. In this way, envelopes are first randomly selected to determine the side under laser radiation. Then envelopes are selected to determine the type of intervention (or control) in the first session, Blinding description: Patient is blinded by putting shield glasses on his/her eyes and thus he/she is unaware about the activation of the laser device. Result assessor is unaware about which method is used in the session and will only enters the pain score and so on he/she is blinded. The data is given to the analyzer by certain codes and he analyzes only the codes without knowing about their nature. N/A anesthesia. Intervention 1: Intervention group: low level laser konftec 808 nm 6.3 J, 23s on every point will be used on 12 point (6 point intra-oral and 6 point extra-oral) 45 minutes after block injection. Intervention 2: Control group: off mod laser will be located on 12 points like intervention group. Yes - There is a plan to make this available What will be shared: the recorded date can be shared based on the studied indicators after identifying the samples individuals. these data include the numbers and scores reported from sensitivity to touch and trauma due to biting. When: starting 6 months after publication To whom: researchers working in academic and scientific institutes can apply for access to data. Conditions: performing statistical analysis to compare data with other studies this field is one of the conditions for access to data, so the analysis must be appropriate to the type of data received from the applicant. Where to obtain: The applicant can apply for access to the data via email zahra_kia_ss@yahoo.com. How to obtain: after submitting the request by e-mail, the applicant will be able to access the information within one week after submitting the request, if has the request conditions. Comments:
public Fateme Shekarchi
Shahid Beheshti Dental school, Daneshjoo Blvd, Velenjak
Tehran Iran (Islamic Republic of) 1234567891 +98 21 2217 5350 zahra_kia_ss@yahoo.com Shahid Beheshti University of Medical Sciences scientific Fateme Shekarchi
Shahid Beheshti Dental school, Daneshjoo Blvd, Velenjak
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2217 5350 zahra_kia_ss@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Children 6-9 years old without systemic disease Children with Frankel level 3 and 4 Patients who need pulpotomy of left and right mandibular primary molars under inferior alveolar nerve block. 6 years 9 years Both history of sensitivity to anesthetics and sulfate errors in the injection of anesthesia during the study. Treatment - Devices Placebo Intervention group: low level laser konftec 808 nm 6.3 J, 23s on every point will be used on 12 point (6 point intra-oral and 6 point extra-oral) 45 minutes after block injection. Control group: off mod laser will be located on 12 points like intervention group The duration of the anesthesia. Timepoint: 45 minutes after injection and then every 10 minutes. Method of measurement: touching by a sharp object. Shahid Beheshti University of Medical Sciences Approved 2022-11-14 Ethics committee of Shahid Beheshti University of Medical Sciences no. 3, Nikkhu alley, Tabriziar ave., Mirdamad Blvd. Tehran Tehran Ireland