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IRCT20171219037960N1 IRCT 2018-04-22 The dental clinic of the International Branch of Guilan University of Medical Sciences (IB-GUMS) Evaluation of the "Water On Tray" anesthetic technique efficacy Comparison of inferior alveolar nerve block success rate in mandible in Halsted technique and "Water On Tray" technique in the patients referred to the dental clinic. 2017-10-23 anticipated 90 Complete https://irct.ir/trial/28358 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In Water On Tray technique, because of the bent needle to 90 degrees and the possibility of approximate perpendicular injection, while the bone contact remains, The Halsted problem solved.The main idea and the name of this technique are adapted from the liquids nature, spreading on a surface-once they pour; on the other words, the anesthetic solution spreads on the ramus surface after injection and deliver to the inferior alveolar nerve and the lingual nerve, Randomization description: Each of the subjects, if they have inclusion criteria, will enter in one the injection groups via the result of the coin toss(Lion will be Halsted and Line will be WOT), Blinding description: After receiving consent, all surveyors are informed that they are likely categorized in the studied group randomly, with considering the fact that no excessive danger exists and only the injection method is different. N/A The comparison of inferior alveolar nerve block success rate in mandible in Halsted technique and Water ON Tray technique. Intervention 1: Intervention group: In this group, we conduct the inferior alveolar nerve block with the long needle (25mm, gauge 27) which bent by own cap (to achieve an approximate perpendicular surface on the medial surface of the ramus) Also, the tip of the needle remains the contact to the bone, during the injection. The main idea and the name of the technique are adapted from the liquids nature, which spread on a board as soon as the pour; In this technique, the anesthetic solution will spread on the ramus surface after injection and receive to the inferior alveolar nerve and the lingual nerve. The used cartridge contains 2% lidocaine with 1:80000 epinephrine. Intervention 2: Control group: The control group undergoes Halsted technique, according to the method which mentioned in Malamed SF. Handbook of local anesthesia. 6th ed-2013. In this method, the needle is straight and doesn`t contact bone during injection. In this group, like the interventional group, we use the long needle (25mm, gauge 27) and the cartridge contains 2% lidocaine and 1:80000 epinephrine. Yes - There is a plan to make this available What will be shared: The subjects are coded and just the data will present to the investigators. When: 6 month after publication To whom: The Universities of medical sciences and valid research organizations Conditions: Repeat the research project in the other place or the other situation or complete the project. Where to obtain: Via the chief investigator`s email How to obtain: Via organizational email and present the documents based on investigation in official organization Comments:
public Seyed Hadi Hoseini
Fouman - Saravan Rd
Rasht Iran (Islamic Republic of) 41941-73774 +98 13 3348 6406 drhadihoseini@gums.ac.ir Rasht University of Medical Sciences scientific Seyed Hadi Hoseini
Fouman - Saravan Rd
Rasht Iran (Islamic Republic of) 41941-73774 +98 13 3348 6406 drhadihoseini@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Patients which need the dental treatment in mandible All of the subjects of this study are in ASA I classification. All of the subjects must have the vital first mandibular premolar in the side of injection, in order to conducted electric pulp test. 15 years 40 years Both Certain noncardiovascular disease (e.g., thyroid dysfunction, diabetes, sulfite sensitivity). Consuming MAO inhibitors Consuming of Tricyclic Antidepressant Consuming of Phenothiazines The subjects who state the acute pain as the chief complaint throughout history Treatment - Other Treatment - Other Intervention group: In this group, we conduct the inferior alveolar nerve block with the long needle (25mm, gauge 27) which bent by own cap (to achieve an approximate perpendicular surface on the medial surface of the ramus) Also, the tip of the needle remains the contact to the bone, during the injection. The main idea and the name of the technique are adapted from the liquids nature, which spread on a board as soon as the pour; In this technique, the anesthetic solution will spread on the ramus surface after injection and receive to the inferior alveolar nerve and the lingual nerve. The used cartridge contains 2% lidocaine with 1:80000 epinephrine. Control group: The control group undergoes Halsted technique, according to the method which mentioned in Malamed SF. Handbook of local anesthesia. 6th ed-2013. In this method, the needle is straight and doesn`t contact bone during injection. In this group, like the interventional group, we use the long needle (25mm, gauge 27) and the cartridge contains 2% lidocaine and 1:80000 epinephrine. The rate of the inferior alveolar nerve block in the first injection via Water On Tray technique. Timepoint: The numbness evaluation conducts every 30 seconds after 2 minutes. Method of measurement: We ask the subjects about the lack of feeling the stick test (Dental explorer for extraoral evaluation and the 25 gauge needle for intraoral), then the moment record as the numbness time in the minute unite. The pain rate during the injection. Timepoint: After injection. Method of measurement: Asking the patient according to Numeric Scale Rate of pain. The dental clinic of the International Branch of Guilan University of Medical Sciences (IB-GUMS) Approved 2017-11-25 Ethics committee of Guilan University of Medical Sciences across from the 17th Shahrivar Hospital-Shahid Siadati St-Namjou St. Rasht Guilan Iran (Islamic Republic of)