]>
IRCT20180804040693N1 IRCT 2018-08-24 Laser Research Center of Dentistry, Tehran University of Medical Sciences The effect of laser on soft tissue anesthesia Clinical assessment of laser application (Photobiomodulation) for reversal of soft-tissue local anesthesia in children 2018-09-23 anticipated 34 Complete https://irct.ir/trial/33072 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Supportive, Randomization description: After reviewing the inclusion and exclusion criteria, each patient randomly using simple randomization and individual (open envelope sealed) divided into two groups of treated with laser and without laser in two treatment sessions with an interval of 7 to 10 days (split- mouth). There are 9 envelopes from each of the four modes (right with laser radiation, right without laser radiation, left with laser radiation, left without laser radiation). We ask a patient to choose an envelope from 36 envelopes and the envelope will be opened by the person responsible for the laser radiation at the same time, Blinding description: For blind clinical care and the outcome evaluator and researcher, a separate person is responsible for laser radiation. So these people are blind at all stages of the laser radiation protocol. For blind the patient, at a meeting without laser treatment, the extinguishing laser appears symbolically with the same distance and the same duration of exposure. For blind analyzer, first analysis is done and then grouped into groups. N/A The effect of laser in reversing local anesthesia. Intervention 1: Intervention group: Laser therapy with an 810 nm wavelength laser diode (Fox, ARC laser Germany) with a 0.5 cm2 cross-section handpiece with a density of 6 J / cm2, a power of 200 mw, and an irradiation time of 15 seconds per continuous wave in soft tissue at the injection side (Infiltration point and anesthetized points on the lower lip). Intervention 2: Control group: The Laser when it's off is symbolically illuminated with the same distance and the same duration. Yes - There is a plan to make this available What will be shared: information about the main outcome When: Starting the access period from 1399 To whom: Researchers working in academic and scientific institutions Conditions: further research Where to obtain: Email to z-hosseini@razi.tums.ac.ir How to obtain: Explain the use of documentation that will be Comments:
public Zahra Hosseini
North Kargar Ave.,Tehran
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5950 z-hosseini@razi.tums.ac.ir Tehran University of Medical Sciences scientific Zahra Hosseini
North Kargar Ave.,Tehran
Tehran Iran (Islamic Republic of) 1439955991 +98 21 8801 5950 z-hosseini@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) A child aged 4 to 8 years who is able to understand and respond to soft tissue sensation Complete the informed consent form by the parent or legal guardian of the patient Children who are ranked 3 or 4 on Frankl Rating Requiring treatment by injection under anesthetic infiltration of mandibular primary first molar 4 years 8 years Both History of allergy to the substance of numbness and sulfite Receiving any pain medication at least 24 hours before treatment Any systemic conditions that prevent dental treatment under local anesthesia Y48.3 Local anaesthetics (Adverse effect in therapeutic use) Treatment - Other Placebo Intervention group: Laser therapy with an 810 nm wavelength laser diode (Fox, ARC laser Germany) with a 0.5 cm2 cross-section handpiece with a density of 6 J / cm2, a power of 200 mw, and an irradiation time of 15 seconds per continuous wave in soft tissue at the injection side (Infiltration point and anesthetized points on the lower lip) Control group: The Laser when it's off is symbolically illuminated with the same distance and the same duration Time of soft tissue local anesthesia. Timepoint: Assessment of sensation of soft tissue every 15 minutes. Method of measurement: Palpation with explorer in trained child. Trauma to soft tissue. Timepoint: At the end of the treatment and 24 hours later. Method of measurement: Observation. Laser Research Center of Dentistry, Tehran University of Medical Sciences Approved 2018-07-21 Ethics committee of tehran University of Medical Sciences N Kargar, Tehran Tehran Tehran Iran (Islamic Republic of)