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IRCT20150720023253N5 IRCT 2022-05-10 Shahid Beheshti University of Medical Sciences The effect of AH26 and Resil sealers on pain after endodontic treatment The effect of AH26 and Resil resin sealers on postoperative pain after endodontic treatment in patient with irreversible pulpitis: A randomized controlled clinical trial study 2022-05-10 anticipated 100 Complete https://irct.ir/trial/61780 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The permuted block randomization method randomly divides 100 patients into two groups. Eighteen blocks, each with four subjects, are assumed. The statistician generates the random sequence for each block using the Excel software (Microsoft Corporation, Redmond, WA, USA). Following the random sequence, a nurse places the sealer and VAS diagrams into similar opaque bags labeled for each block and opens only after chemo-mechanical preparation and before the obturation. The investigator is unaware of the coding details, Blinding description: A research assistant not involved in the treatment performs allocation by random permuted block and stratification by gender. Computer-generated randomized patient codes concealed in opaque envelopes are revealed just before obturation. The envelopes are opened by an assistant not involved in the research, but only when the endodontic sealer is going to be inserted into the root canal. Patients are randomized for the endodontic sealer used (AH26, Resil). Each patient can contribute a maximum of two teeth only when they are on opposite sides of the mouth. Patients are blinded to the treatment allocation, and clinicians are also blinded to the treatment allocation up to obturation. The operator knows which sealer will be used right before filling the root canal. The patients are blinded to the sealer. 3 Irreversible pulpitis. Intervention 1: Intervention group: After canal preparation and selecting the gutta-percha cone, the AH26 resin sealer is placed in the canals for obturation. Intervention 2: Intervention group: After canal preparation and selecting the gutta-percha cone, the Resil resin sealer is placed in the canals for obturation. 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 more information.
public Dr. Nazanin Zargar
Shahid Beheshti University of Medical Sciences., Daneshjou Blvd., Velenjak., Tehran
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2217 5350 nzargar48@yahoo.com Shahid Beheshti University of Medical Sciences scientific Dr. Nazanin Zargar
Shahid Beheshti University of Medical Sciences., Daneshjou Blvd., Velenjak., Tehran
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2217 5350 nzargar@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 60 years Patients who do not have systemic problems and immunosuppression and are not treated with medication. Patients who are not allergic to the medicines used during endodontic treatment and local anesthetics. Patients with a long-term positive pulp response to the cold test and EPT (moderate to severe responses (vas = 40-100)) or long and delayed responses. Patients diagnosed with irreversible pulpitis in the first or second mandibular molars. Patients with healthy periapical tissue (confirmed by radiography and clinic) 18 years 60 years Both Symptomatic teeth that need emergency endodontic treatment. Teeth that have been treated in two sessions. Patients who have been taking analgesics or antibiotics for the past seven days. Patients with periodontal disease (probe depths greater than 4 mm). Teeth with open apex, apical resorption, or canal calcification. Patients who have multiple teeth in need of endodontic treatment. Teeth that have been treated with crown. Patients taking antibiotics after treatment for any reason. Patients with allergies to nonsteroidal anti-inflammatory drugs Patients who are pregnant or breastfeeding. Overfilling treatments (gutta-percha or sealer extrusion beyond radiographic apex). Under filing treatments (more than 2 mm shorter than radiographic apex). Teeth with severe crown destruction need core build-up crowns. K04.0 Pulpitis Treatment - Drugs Treatment - Drugs Intervention group: After canal preparation and selecting the gutta-percha cone, the AH26 resin sealer is placed in the canals for obturation. Intervention group: After canal preparation and selecting the gutta-percha cone, the Resil resin sealer is placed in the canals for obturation. Number of pain after root canal treatment. Timepoint: 6,12,24,48 hours after treatment and 3,4,5,6 and 7 days after treatment. Method of measurement: visual analog scale. Dosage of analgesics consumption. Timepoint: 6,12,24,48 hours after treatment and 3,4,5,6 and 7 days after treatment. Method of measurement: Number of medicaments taken. Shahid Beheshti University of Medical Sciences Approved 2021-12-26 Ethics Committee of Shahid Beheshti University of Medical Sciences, School of Dentistry Shahid Beheshti University of Medical Sciences., Daneshjou Blvd., Velenjak., Tehran Tehran Tehran Iran (Islamic Republic of)