IRCT20250510065680N1 IRCT 2025-07-01 Tehran University of Medical Sciences Comparison of Different Types of Bioceramic Sealers on Post-Treatment Pain in Symptomatic Teeth Comparative analysis of postoperative pain in symptomatic irreversible pulpitis teeth following single cone obturation Using three Different Sealers: A Randomized Clinical Trial 2025-08-23 anticipated 75 Complete https://irct.ir/trial/83702 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Total Score Calculation The total score for each patient is determined by summing the points assigned to the type of medication, time of consumption, and dosage. This cumulative score is referred to as the "Analgesic Consumption Score." Stratified Randomization Patients are classified into different groups based on their analgesic consumption score before randomization: - Group 1: Low score (0–3) - Group 2: Moderate score (4–6) - Group 3: High score (7–10) Patients are further divided into subgroups based on two main factors: 1. Degree of analgesic consumption (as explained above) 2. Gender (male or female) Randomization Process For each possible combination of gender and analgesic consumption level, an envelope containing three sheets labeled with treatment groups A, B, and C is prepared. Considering both factors (gender and analgesic consumption level), the possible combinations are as follows: - Female, low analgesic consumption - Female, moderate analgesic consumption - Female, high analgesic consumption - Male, low analgesic consumption - Male, moderate analgesic consumption - Male, high analgesic consumption Thus, the total number of possible combinations is six. Preparation of Envelopes For each of the six combinations above, a separate envelope is prepared, each containing three sheets labeled A, B, and C. Consequently, a total of six envelopes must be prepared. Treatment Group Selection Process When a patient—e.g., a female with high analgesic consumption—arrives, they receive the envelope corresponding to their combination ("Female, high analgesic consumption") and select one of the sheets inside. If the patient selects Group A, subsequent patients with the same characteristics (female, high analgesic consumption) will only be able to choose between Groups B and C. This process continues until the number of patients in each treatment group reaches 25. Final Patient Distribution Ultimately, patients will be evenly distributed across the three treatment groups, ensuring that each group consists of 25 patients. This approach helps prevent biases related to gender or analgesic consumption levels, Blinding description: The patient is unaware of the type of sealer used. Likewise, the operator remains blinded to the sealer type until the obturation phase, ensuring that their performance is not influenced by the specific sealer applied. Furthermore, in the post-treatment pain analysis, the operator does not participate in recording the patient's pain levels after the procedure. Instead, this task is conducted by a third-party evaluator to maintain objectivity and eliminate potential bias. 3 Comparison of post endodontic pain with various sealers. Intervention 1: Intervention group 1 : Endoseal Tcs Sealer. Intervention 2: Intervention group 2: Neosealer bioceramic sealer. Intervention 3: Control group: AH plus sealer. 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 "The release plan has not been determined yet, and this does not mean that there is no intention for it.