Comparative analysis of postoperative pain in symptomatic irreversible pulpitis teeth following single cone obturation Using three Different Sealers: A Randomized Clinical Trial

Assessment and Comparison of Post-Endodontic Treatment Pain in Teeth with Irreversible Pulpitis Using Bioceramic Sealers (EndoSeal TCS and NeoSeal) vs. Resin-Based Sealer (AH Plus

A Phase 2 randomized, double-blind clinical trial with parallel groups, including a control group, was conducted on 75 patients. The randomization process was carried out using the rand function in Microsoft Excel.

Double-blinding ensures unbiased pain assessment using the VAS scale. The study aims to identify optimal sealers for minimizing post-endodontic pain and guiding clinicians toward more effective treatment choices. Conducted at Tehran University’s Dental School

This study evaluates post-treatment pain in patients aged 18–50 with symptomatic irreversible pulpitis in the first molars of the maxilla or mandible. Inclusion criteria involve adequate oral hygiene, prolonged positive responses to cold and electric pulp testing, and the absence of radiographic periapical lesions. Patients with complex anatomy, systemic diseases, or allergies to treatment materials are excluded.

The two types of bioceramic sealers, Neosealer and Endoseal TCS, are being compared with the resin-based sealer AH Plus, as control group.

Pain intensity, the number of analgesic tablets consumed, the type of sealer prescribed, and the time of pain assessment.

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.

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.