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IRCT20260309068976N1 IRCT 2026-08-08 Esfahan University of Medical Sciences Comparison of three different materials used for nerve treatment of lower second baby teeth in children? Evaluation of clinical and radiographic success of MTA، cold ceramic and 3-mix in the pulpotomy of mandibular second molars: randomized clinical trial 2026-07-30 anticipated 120 Recruiting https://irct.ir/trial/89420 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated to one of the three treatment groups (MTA, Cold Ceramic, or 3Mix) using block randomization with a 1:1:1 allocation ratio. A computer-generated randomization sequence with fixed or variable block sizes will be prepared by an independent researcher not involved in patient recruitment or treatment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes that will be opened only after the participant has been enrolled, Blinding description: participants, healthcare providers (Physicians, nurses, physiotherapists, etc.) who care for participants during the trial, data collectors, and outcome assessors. N/A Pulpotomy، Triple antibiotic paste، clinical Trial، primary teeth، bioceram، MTA Angelus. Intervention 1: Intervention group 1: Pulpotomy of mandibular second primary molars using Cold Ceramic as the pulpotomy agent. Following coronal pulp removal and hemostasis, Cold Ceramic is placed over the radicular pulp, and the tooth is restored according to the study protocol. Intervention 2: Intervention group 2: Pulpotomy of mandibular second primary molars using Mineral Trioxide Aggregate (MTA) as the pulpotomy agent. After coronal pulp removal and hemostasis, MTA is placed over the radicular pulp, followed by restoration according to the study protocol. Intervention 3: Intervention group 3: Pulpotomy of mandibular second primary molars using 3Mix antibiotic paste as the pulpotomy agent. After coronal pulp removal and hemostasis, 3Mix paste is applied over the radicular pulp, followed by restoration according to the study protocol. 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 further information
public Nazanin Nasr
Hezar Jarib Ave.
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 nsrnazanin2000@gmail.com Esfahan University of Medical Sciences scientific Maryam Hajiahmadi
Hezar Jarib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 118 9573 dr.maryamhajiahmadi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 5-8 year old children having at least 1 primary second molar with the indication of pulpotomy The teeth must not have pathological signs such as spontaneous pain, pathological luxation, internal resorption ,External resorption,PDL widening, inter-radicular radiolucency , Calcific metamorphosis. Does not have a periapical lesion 5 years 8 years Both Systemic problems Physical and mental limitations Inability to properly restore the tooth, Sensitivity to therapeutic materials Patient's failure to attend follow-up appointments Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Pulpotomy of mandibular second primary molars using Cold Ceramic as the pulpotomy agent. Following coronal pulp removal and hemostasis, Cold Ceramic is placed over the radicular pulp, and the tooth is restored according to the study protocol. Intervention group 2: Pulpotomy of mandibular second primary molars using Mineral Trioxide Aggregate (MTA) as the pulpotomy agent. After coronal pulp removal and hemostasis, MTA is placed over the radicular pulp, followed by restoration according to the study protocol. Intervention group 3: Pulpotomy of mandibular second primary molars using 3Mix antibiotic paste as the pulpotomy agent. After coronal pulp removal and hemostasis, 3Mix paste is applied over the radicular pulp, followed by restoration according to the study protocol. Clinical success of pulpotomy in mandibular second primary molars treated with Mineral Trioxide Aggregate (MTA), Cold Ceramic, or 3Mix antibiotic paste, assessed by the absence of spontaneous pain, swelling, sinus tract, pathological mobility, and tenderness to percussion. Timepoint: 3,6,12 months. Method of measurement: Clinical scoring table. Radiographic success of pulpotomy in mandibular second primary molars treated with Mineral Trioxide Aggregate (MTA), Cold Ceramic, or 3Mix antibiotic paste, assessed by the absence of furcation/periapical radiolucency and pathological internal or external root resorption. Timepoint: 6,12 months. Method of measurement: Radiographic scoring table. Esfahan University of Medical Sciences Approved 2026-07-27 Faculties of Dentistry, Health and Modern Medical Technologies, Isfahan University of Medical Scienc Hazar Jarib Ave. Esfahan Isfehan Iran (Islamic Republic of)