]>
IRCT20191004044977N1 IRCT 2019-12-17 Yazd University of Medical Sciences Anesthesia of mandibular primary molars Comparison of effectiveness of articaine and lidocaine on depth of anaesthesia in mandibular primary molars teeth 2019-12-21 anticipated 30 Complete https://irct.ir/trial/42725 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method was blocked. Randomization unit was individual. Randomization tool was sealed envelops. For allocation concealment, two sealed envelops were used for every patient in the first appointment; one determined extraction side and another was for drug type, Blinding description: The principle investigator who is aware of type of intervention would inject and extract tooth.The blinded dentist would collect the data . Considering blinding of data collector and the patient in every appointment this study is double blinded. Also the statistics analyst is not aware of type of intervention for each patient. 3 Condition 1: Effectivness of articaeine during mandibular primary molar extraction. Condition 2: Effectivness of lidocaine during mandibular primary molar extraction. Intervention 1: Intervention group: Injection of 1/8 ml of 4% articaine with 1:100000 epinephrin in buccal infiltration. Intervention 2: Control group: Injection of 1/8 ml of 2% lidocaine with 1:100000 epinephrin in buccal infiltration. Yes - There is a plan to make this available What will be shared: Undetectable information such as age, sex, type of tooth under extraction (first or second molar), amount of root remaining to be extracted and previous dental treatments history will be published. Study outcomes will also be published, including changes in blood pressure, pulse rate, wong Baker Facial Pain Scale and Face Leg Activity Cry Consolability Scale. When: Starting 9 months after publication To whom: The data are only available for people working in academic institutions. Conditions: Use of this data is permitted for systematic review and meta-analysis . Similar clinical trials can also use to criticiza the present study and its results in their discussion. Where to obtain: Send an email to 1 : mrezaei2024@gmail.com 2: zbahrololoom@yahoo.com How to obtain: After the request via one of the two methods listed above, if the request matches the sharing information mentioned before, this information will be available to the applicant within one month. Comments:
public Maedeh Rezaei
Dahe fajr Ave, Imam Reza Square, Dentistry Faculty of Shahid Sadoughi university of medical science
Yazd Iran (Islamic Republic of) ۸۹۱۴۸-۱۵۶۶۹ +98 35 3621 4257 mrezaei2024@gmail.com Yazd University of Medical Sciences scientific Maedeh Rezaei
Dahe Fajr Ave, Imam Reza Sqare, Dentistry Faculty of Shahid Sadoughi university of medical science
Yazd Iran (Islamic Republic of) ۸۹۱۴۸-۱۵۶۶۹ +98 35 3621 4257 mrezaei2024@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Children aged 6 to 9 years old who require bilateral extraction of primary mandibular molars Children with grade 3 or 4 of frankl behavior rating scale Unrestorable primary mandibular molars Primary mandibular molars with at least on third of the roots Children whithout systemic disease or drug allergy Children with ability of communication in persian language Children without learning disability 6 years 9 years Both Ukncooperative children Teeth with acute abcess Use of analgesics before treatment Failure in complete anaesthesia after injection Y48.3 Y48.3 local anaesthesia local anaesthesia Treatment - Drugs Treatment - Drugs Intervention group: Injection of 1/8 ml of 4% articaine with 1:100000 epinephrin in buccal infiltration Control group: Injection of 1/8 ml of 2% lidocaine with 1:100000 epinephrin in buccal infiltration Score of self-reported pain by children during mandibular primary molars extraction based on Wong Baker Facial Scale after anaesthesia with articaine or lidocaine. Timepoint: After tooth extraction. Method of measurement: Wong Baker Facial Pain Scale. Calculated Score of child pain by investigartore during mandibular primary molars extraction based on Face Leg Activity Cry Consolability Scale after anaesthesia with articaine or lidocaine. Timepoint: During tooth extraction. Method of measurement: Face Leg Activity Cry Consolability Scale. Blood pressure changes before and after tooth extraction. Timepoint: before and after tooth extraction. Method of measurement: Blood pressure monitor. Pulse rate changes before and after tooth axtraction. Timepoint: before and after tooth extraction. Method of measurement: Pulse oximeter. Yazd University of Medical Sciences Approved 2019-09-17 Ethics committee of Shahid sadoughi University of Medical Sciences Dahe Fajr Ave, Imam Reza Square, Denistry Faculty Yazd Yazd Iran (Islamic Republic of)