Comparison of pain after endodontic treatment using AH Plus sealer and CC sealer

Comparison of pain after endodontic treatment using AH Plus sealer and CC sealer

Randomized controlled clinical trial using a simple random allocation method on 80 patients

80 patients with molars or premolars with irreversible pulpitis who refer to Shahid Sadoughi Dental School and meet the inclusion criteria will participate. All patients will be treated in a single session by the residents of the specialized department. First, the pain level before treatment is recorded based on the Verbal Rating Scale (VRS) as well as the periapical condition of the tooth in question, and patients are assigned to one of two groups, A or B, using a simple random assignment method. The patient is advised to take painkillers if they experience unbearable pain. Patients will be followed up by telephone at intervals of 6, 24, 48, and 72 hours after treatment to record the level of pain based on a verbal rating scale.

Inclusion criteria: Patients with mandibular molars or premolars with irreversible pulpitis. The tooth must be restorable. The root apex must be closed. Exclusion criteria: Patients' refusal to provide informed consent. Having another painful tooth in the same side of the mouth. The patient not being in a normal state of intelligence.

Intervention group: After cleaning and shaping the root canal using rotary files and normal saline irrigation, gutta-percha and CC sealer(Samin, Iran)are used to obturation the root canal space in the same session. Control group: After cleaning and shaping the root canal using rotary files and normal saline irrigation, gutta-percha and AH Plus (Dentsply Sirona, USA) sealer are used to obturation the root canal space in the same session.

Pain after root canal treatment

For randomization, the simple allocation method will be used, and in this study, the unit of randomization is the individual. To perform randomization, an allocation list will be generated in advance. For this purpose, using PASS software (version 2021) and selecting the "Simple Randomization" option, a random sequence for 80 participants will be generated. The software output will specify which of the two groups—'A' (recipient of AH Plus sealer) or 'B' (recipient of CC sealer)—each of the sequence numbers 1 to 80 belongs to. This list will be stored in an Excel file and will be accessible only to a research assistant who has no involvement in the enrollment and intervention processes. After determining the eligibility of each patient for entering the study and obtaining informed consent, the aforementioned assistant, based on the order of patient enrollment (first patient = number 1, second patient = number 2, etc.), will only announce the sequence number assigned to that patient. Then, based on the pre-generated list, the type of sealer (AH Plus or CC) will be determined, and the treatment will be performed by the endodontist. This method eliminates the possibility of predicting future group allocation.