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IRCT20180228038901N1 IRCT 2018-04-30 Vice chancellor for research, Tabriz University of Medical Sciences Efficacy of Mannitol on the success rate of anesthesia in mandibular posterior teeth IANB Aneasthetic success of Articaine\Epinephrine with combination of Mannitol in comparison with Articaine\Epinephrine for inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: A randomized controlled clinical trial 2018-04-04 anticipated 124 Complete https://irct.ir/trial/30072 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will have 62 patients in each group (31 women and 31 men) who will be randomly assigned into two groups. The randomization unit will be individual and the randomization tool will be Randlist software. Each patient entering the study will be assigned a number from 1 to 62 (for male and female) as a special code and they will be randomly put into two groups according to sorted numbers which will be set by software. The person who will randomize will not be aware of how to study, Blinding description: Pulp condition realizing tests and injection by one person and providing an access cavity and recording pain will be done by another person.Groups data will be coded and reported as A,B to analyzer,so the analyzer and pain recorder are not aware of the study technique. 3 Symptomatic irreversible pulpitis. Intervention 1: Intervention group1:IANB(Inferior alveolar nerve block) standard injection using Articaine 4% solution(DENTACAIN,Exir,Iran ) will be done . After 15 minutes of block anesthesia and numbness of the lips, the teeth will be isolated and the access cavity will be done. Intervention 2: Intervention group 2: under sterile conditions, 1.9 mL of 4% Articaine with 1:200,000 epinephrine will be drawn from standard dental cartridges (DENTACAIN,Exir,Tehran,Iran) into a sterile 3-mL Luer-Lok disposable syringe (AVA,Tehran.,Iran). 1.1 mL of 0.5 mol/L mannitol will be added to this syringe, which will be withdrawn from a 500-mL solution of a 20% supersaturated mannitol solution (American Regent Laboratories, Inc, Shirley, NY) by using a sterile disposable syringe.To mixing the solution the combined Articaine/mannitol formulation in the syringe will be then inverted 20 times.Before the mannitol be added to the syringe containing the Articaine with epinephrine, the 50- mL vial will be heated in a water bath (Teledyne Hanau, Buffalo, NY) to 80_C for 15 minutes to remove any crystals present in the supersaturated solution .A standard IAN block will be done by using a 27-gauge, 1½-inch needle (AVA,Tehran,Iran), enclosed to the Luer-Lok syringe. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Sahar Shakouei
3rd floor, No. 2 Cental Building ,Tabriz University of Medical Science,Golgasht St
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 5965 sshakouie@hotmail.com Dental and Periodontal Research Center scientific Sahar Shakouei
3rd floor, No2 Central Building , Tabriz University of Medical Sciences, Golgasht St
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 5965 sshakouie@hotmail.com Faculty of Dentistry Iran (Islamic Republic of) patients without relevant medical conditions patients older than 18 Patients not taking beta-blockers patients not being medicated with any opioids preoperatively patients without drug abusing No pregnant or nursing mothers Those without a contraindication for the use of Mannitol Those known not to be allergic to one of the study medications Those without orofacial infection 18 years 65 years Both subjects with negative response to cold testing Teeth with periradicular disease(unlike a widened periodontal ligament) K04.0 Pulpitis Treatment - Other Treatment - Other Intervention group1:IANB(Inferior alveolar nerve block) standard injection using Articaine 4% solution(DENTACAIN,Exir,Iran ) will be done . After 15 minutes of block anesthesia and numbness of the lips, the teeth will be isolated and the access cavity will be done. Intervention group 2: under sterile conditions, 1.9 mL of 4% Articaine with 1:200,000 epinephrine will be drawn from standard dental cartridges (DENTACAIN,Exir,Tehran,Iran) into a sterile 3-mL Luer-Lok disposable syringe (AVA,Tehran.,Iran). 1.1 mL of 0.5 mol/L mannitol will be added to this syringe, which will be withdrawn from a 500-mL solution of a 20% supersaturated mannitol solution (American Regent Laboratories, Inc, Shirley, NY) by using a sterile disposable syringe.To mixing the solution the combined Articaine/mannitol formulation in the syringe will be then inverted 20 times.Before the mannitol be added to the syringe containing the Articaine with epinephrine, the 50- mL vial will be heated in a water bath (Teledyne Hanau, Buffalo, NY) to 80_C for 15 minutes to remove any crystals present in the supersaturated solution .A standard IAN block will be done by using a 27-gauge, 1½-inch needle (AVA,Tehran,Iran), enclosed to the Luer-Lok syringe The amount of pain. Timepoint: During access cavity preparation and entrance in to the pulp chamber and the root canal. Method of measurement: Using Visual Analog Scale. Vice chancellor for research, Tabriz University of Medical Sciences Approved 2018-03-12 Ethics committee of Tabriz University of Medical Sciences 3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)