]>
IRCT20180930041187N1 IRCT 2019-02-05 Shahid Beheshti University of Medical Sciences Comparison of two methods of intraosseous injection and lower alveolar nerve block in the first mandibular molars with irreversible pulpitis. Evaluation of the Anesthetic Efficacy of Intraosseous Anesthesia By Quicksleeper 5 computer-controlled system Versus inferior alveolar nerve Block in first Mandibular Molars with Irreversible Pulpitis. 2019-02-04 anticipated 64 Complete https://irct.ir/trial/34186 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals after obtaining consent to participate in this research are divided by stratified balanced block randomization method Into four groups (A, B, C and D) with 16 people in every group. N/A Asymptomatic irreversible pulpitis. Intervention 1: Intervention group: For the first group (18 to 40 years old), Intraosseous injection technique would be used to achieve primary pulpal anesthesia using a QuickSleeper 5 device product by (Dental Hi Tec). Intervention 2: Intervention group: For the second group (40 to 60 years old), Intraosseous injection technique would be used to achieve primary pulpal anesthesia using a QuickSleeper 5 device product by (Dental Hi Tec). Intervention 3: Intervention group: For the third group (18 to 40 years old), inferior alveolar nerve block technique (conventional technique) would be used to achieve primary pulpal anesthesia. Intervention 4: Intervention group: For the fourth group (40 to 60 years old), inferior alveolar nerve block technique (conventional technique) would be used to achieve primary pulpal anesthesia. Yes - There is a plan to make this available What will be shared: All collected deidentified individual Participant Data. When: Starting 3 months after publication To whom: Available for researchers working in academic and scientific institutions. Conditions: There is no limitation for what types of analyses will be used. Where to obtain: Saeed Gharibian / saeed.gharibian@gmail.com / 00989120236300 How to obtain: The applicant sends a request by sending an e-mail to the above-mentioned email; after reviewing his/her request, the data file will be sent to him/her within a maximum of one month. Comments:
public Saeed Gharibian bejestani
No. 7,Mehr Ave., bostan dovom Street., Pasdaran Street., Tehran City
Tehran Iran (Islamic Republic of) 1664869593 +98 21 2276 3836 saeed.gharibian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr Shiva Shojaeian
Dental school, Shahid Beheshti University,Daneshju Blv, Evin Blv, Chamran Highway
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2240 3075 shiva_sh84@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The age of the patient is over 18 years and under the age of 60 years Patient Satisfaction to enter the study Patients have the ability to read and understand the consent and sign it Patients should have at least one first vital mandibular molar without spontaneous pain and positive response to Electrical Pulp Tester and prolonged response to the cold test The absence of periapical radiolucency or any periapical lesions in radiography Patients without any systemic diseases Absence of acute inflammation and advanced periodontal disease at the first mandibular molar and adjacent Molar and premolar teeth and injection area 18 years 60 years Both History of any cardiovascular disease and high blood pressure Lactate or pregnant women Any history of alergy to anesthetic solutions Using analgesic drugs since 12 hours before the treatment Mobility more than 0.5 mm Probing more than 3 mm in mesial and distal Severe dental pain that needs emergency treatment Non vital coronal pulp tissue Teeth with full crown No lip numbness after the Inferior Alveolar Nerve Block injection No pulp exposure after removing caries lack of cooperation or interest of patient to continue the study K04.0 Asymptomatic irreversible pulpitis Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group: For the first group (18 to 40 years old), Intraosseous injection technique would be used to achieve primary pulpal anesthesia using a QuickSleeper 5 device product by (Dental Hi Tec). Intervention group: For the second group (40 to 60 years old), Intraosseous injection technique would be used to achieve primary pulpal anesthesia using a QuickSleeper 5 device product by (Dental Hi Tec). Intervention group: For the third group (18 to 40 years old), inferior alveolar nerve block technique (conventional technique) would be used to achieve primary pulpal anesthesia. Intervention group: For the fourth group (40 to 60 years old), inferior alveolar nerve block technique (conventional technique) would be used to achieve primary pulpal anesthesia. Success of the Anesthesia. Timepoint: After the Injection and during root canal therapy (RCT). Method of measurement: Vitality pulp test (Electrical pulp tester and endo ice) before RCT and questioning from patients during RCT. Pain during injection. Timepoint: During injection of Anesthetic solution and immediately after completion of injection. Method of measurement: Heft-parker visual Analogue Scale. Pain. Timepoint: Before injection (during vital pulp tests), after injection (during the evaluation of anesthesia success). Method of measurement: Heft-parker visual Analogue Scale. Pulse. Timepoint: Before injection , after injection. Method of measurement: Pulse-oximeter. Onset of Anesthesia. Timepoint: After the injection with 1-minute intervals for a period of 15 minutes. Method of measurement: Vitality pulp test (pulp tester and endo ice). Duration of Anesthesia. Timepoint: From the beginning to the end of the treatment session. Method of measurement: Asking from the patients. Anxiety. Timepoint: Before injection. Method of measurement: Visual Analogue Scale for Anxiety. Student Researcher Approved 2017-08-01 Ethics Committee of the Dental Research Institute, Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Dental School, Daneshjoo boulevard, Shahriari square, Velenjak Tehran Tehran Iran (Islamic Republic of)