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IRCT20251003067492N1 IRCT 2025-10-12 Sanandaj University of Medical Sciences Comparison of pain intensity following endodontic retreatment of mandibular molars with Gutta-Percha, Mineral Trioxide Aggregate (MTA), and Cold Ceramic: A randomized clinical trial Evaluation of postoperative pain intensity after retreatment of mandibular molar teeth obturated with gutta-percha, Mineral Trioxide Aggregate (MTA), and Cold Ceramic 2025-11-16 anticipated 60 Complete https://irct.ir/trial/86642 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This is a randomized, single-blind, parallel, interventional clinical trial, phase 2/3, conducted on 60 patients, Randomization description: The study will be conducted in three treatment groups, as detailed below: 1. Group A : Root canal obturation with Gutta-Percha using Cold Lateral Compaction (CLC) technique. 2. Group B: Root canal obturation with MTA (Angelus, Brazil): the apical one-third is filled with an MTA plug, and the coronal two-thirds are filled using the Backfill technique. 3. Group C: Root canal obturation with Cold Ceramic (Samin, Iran), First, the apical plug is placed, followed by the coronal backfill. • Randomization in this study will be performed using the block randomization method to allocate participants into groups. The final sample size will include 60 participants. The blocks consist of three units and are arranged in a combination of A, B, and C. The final number of blocks is six, and their sequence is as follows: 1. ABC 2. ACB 3. BAC 4. BCA 5. CBA 6. CAB To select the blocks, a random number table is used. In this method, we start from the first number in the table and move from left to right. Whenever a number between 1 and 6 appears, the corresponding block is selected, and numbers outside this range are ignored, Blinding description: Patients will not be aware of the type of canal filling material used. 2-3 Postoperative pain after retreatment of mandibular molar teeth. Intervention 1: Intervention group: Obturation with Gutta-Percha using Cold Lateral Compaction (CLC). Intervention 2: Intervention group: Obturation with Mineral Trioxide Aggregate (MTA) (Angelus, Brazil): the apical one-third is filled with an MTA plug, and the coronal two-thirds are filled using Backfill. Intervention 3: Intervention group: Obturation with Cold Ceramic (Samin, Iran): an apical plug is placed followed by coronal Backfill. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identification of individual participants. When: Access will begin after the publication of the results. To whom: Researchers affiliated with academic and scientific institutions Conditions: Researchers will have access to the data under any circumstances. Where to obtain: For further information, you can contact the corresponding author via the following email: [ahmadyanierfan1@gmail.com] How to obtain: After sending a request via email to the corresponding author, the requester will have unlimited access to the data. Comments:
public Erfan Ahmadyani
Pasdaran, Kurdistan University of Medical Sciences
Sanandaj Iran (Islamic Republic of) 6617713491 +98 937 938 6232 Ahmadyanierfan1@gmail.com Sanandaj University of Medical Sciences scientific Erfan Ahmadyani
Pasdaran, Kurdistan University of Medical Sciences
Sanandaj Iran (Islamic Republic of) 6617713491 +98 937 938 6232 Ahmadyanierfan1@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Patients with asymptomatic mandibular molars requiring endodontic retreatment. Presence of periapical radiolucency on the target tooth. Patients aged over 18 years and under 60 years. Patients able and willing to provide informed consent. 18 years 60 years Both Presence of uncontrolled systemic diseases. Presence of non-odontogenic or chronic pain. N/A N/A N/A Intervention group: Obturation with Gutta-Percha using Cold Lateral Compaction (CLC). Intervention group: Obturation with Mineral Trioxide Aggregate (MTA) (Angelus, Brazil): the apical one-third is filled with an MTA plug, and the coronal two-thirds are filled using Backfill. Intervention group: Obturation with Cold Ceramic (Samin, Iran): an apical plug is placed followed by coronal Backfill Pain intensity after retreatment of mandibular molars obturated with three root canal filling materials: Gutta-percha, Mineral Trioxide Aggregate, and Cold Ceramic. Timepoint: 8, 24, 48, and 72 hours after treatment. Method of measurement: Visual Analog Scale (VAS) questionnaire. Sanandaj University of Medical Sciences Approved 2025-09-30 Ethics Committee of Kurdistan University of Medical Sciences Pasdaran Ave, Kurdistan University of Medical Sciences Sanandaj Kurdistan Iran (Islamic Republic of)