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IRCT20250815066862N1 IRCT 2025-08-26 Khoram-Abad University of Medical Sciences Effects of Oral Steroidal and Non-Steroidal Anti-Inflammatory Drugs on Pain Severity following Inferior Alveolar Nerve Block in Comparing the Effects of Oral Steroidal and Non-Steroidal Anti-Inflammatory Drugs on Pain Severity Following Inferior Alveolar Nerve Block in Mandibular Molars with Symptomatic Irreversible Pulpiti(A Double-Blind Randomized Clinical Trial) 2025-09-06 anticipated 210 Complete https://irct.ir/trial/85552 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sequence Generation and Allocation Concealment: To minimize bias in the allocation of participants to study groups, the random sequence will be generated by an independent individual who is not involved in the conduct of the trial. Participants will be assigned to six treatment groups using the SPSS software and a computer-generated random number generator. The generated sequence will be kept confidential with restricted access to ensure allocation concealment. Therefore, the research team will remain unaware of the group assignment of each participant in advance, Blinding description: This study will use a double-blind design, meaning that both participants and outcome assessors will be unaware of the treatment group assignments. The interventions are designed to be similar in appearance and administration to prevent identification of the groups. The purpose of blinding is to minimize bias during data collection and analysis. The medications/interventions used in the groups will have identical appearance, packaging, and administration to ensure that neither participants nor assessors can identify the assigned groups. 3 Oral Steroidal and Non-Steroidal Anti-Inflammatory , Symptomatic Irreversible Pulpiti. Control group (Placebo):Oral premedication with one capsule containing dextrose as placebo, administered one hour before anesthesia, single oral dose. Capsules are identical in shape, size, and color to the intervention drugs, prepared in sealed, sequentially numbered envelopes.Intervention group 1 (Naproxen):Oral premedication with one 500 mg naproxen tablet (manufactured by [Company/Country]), administered one hour before anesthesia, single oral dose.Intervention group 2 (Dexamethasone):Oral premedication with one 4 mg dexamethasone tablet (manufactured by [Company/Country]), administered one hour before anesthesia, single oral dose.Intervention group 3 (Prednisolone):Oral premedication with one 20 mg prednisolone tablet (manufactured by [Company/Country]), administered one hour before anesthesia, single oral dose.Intervention group 4 (Piroxicam):Oral premedication with one 20 mg piroxicam capsule (manufactured by [Company/Country]), administered one hour before anesthesia, single oral dose.Intervention group 5 (Diclofenac):Oral premedication with one 50 mg diclofenac potassium tablet (manufactured by [Company/Country]), administered one hour before anesthesia, single oral dose.. 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 At this stage, no final decision has been made regarding the sharing of individual participant data (IPD) due to ethical considerations, confidentiality concerns, and the need for further approval from the university ethics committee. The data sharing plan may be updated in the future once a clear policy is established.
public Dr. Maryam Dalaei Moghaddam
Shafipoor blvd
Khorramabad Iran (Islamic Republic of) 6814989468 +98 66 3320 7826 maryam.dalaei@yahoo.com Khoram-Abad University of Medical Sciences scientific Dr.maryam dalaei moghaddam
Shafipoor blvd
Khorramabad Iran (Islamic Republic of) 6814989468 +98 66 3320 7826 maryam.dalaei@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Systemically healthy patients (ASA 1) aged 18 to 60 years with molars with symptomatic irreversible pulpitis (with a history of moderate to severe pain and pain lasting more than 45 seconds on pulp sensibility test) No periapical changes on radiographs (periapical index ≥ 2) Participants who understood the method of using the pain scale. 18 years 60 years Both Systemic disease, immunodeficiency, pregnancy, history of allergy to local anesthetic solutions or any experimental drug The patient is unable to provide informed consent. Taking antibiotics, painkillers, and sedatives up to twelve hours before root canal treatment as part of a study and long-term use of medications. Teeth with trauma, open apex, pulp necrosis (no bleeding observed after access cavity preparation). Treatment - Drugs Control group (Placebo):Oral premedication with one capsule containing dextrose as placebo, administered one hour before anesthesia, single oral dose. Capsules are identical in shape, size, and color to the intervention drugs, prepared in sealed, sequentially numbered envelopes.Intervention group 1 (Naproxen):Oral premedication with one 500 mg naproxen tablet (manufactured by [Company/Country]), administered one hour before anesthesia, single oral dose.Intervention group 2 (Dexamethasone):Oral premedication with one 4 mg dexamethasone tablet (manufactured by [Company/Country]), administered one hour before anesthesia, single oral dose.Intervention group 3 (Prednisolone):Oral premedication with one 20 mg prednisolone tablet (manufactured by [Company/Country]), administered one hour before anesthesia, single oral dose.Intervention group 4 (Piroxicam):Oral premedication with one 20 mg piroxicam capsule (manufactured by [Company/Country]), administered one hour before anesthesia, single oral dose.Intervention group 5 (Diclofenac):Oral premedication with one 50 mg diclofenac potassium tablet (manufactured by [Company/Country]), administered one hour before anesthesia, single oral dose. 1. Success of Inferior Alveolar Nerve Block Anesthesia:The proportion of patients experiencing no pain or mild pain (0–54 mm) measured by the Heft-Parker Visual Analog Scale (VAS) during root canal treatment.2. Pain Intensity During Procedure:The level of pain reported by patients at different stages of treatment (before medication, after local anesthesia, during access cavity preparation, and during file placement) measured by the Heft-Parker VAS. Timepoint: Pain intensity will be measured using the Heft-Parker VAS at four specific time points during the root canal treatment:1. Before premedication administration (baseline)2. After administration of local anesthesia3. During access cavity preparation4. During file placement in the root canals. Method of measurement: Method of measuring the primary outcome variable:Pain intensity is measured using the Heft-Parker Visual Analog Scale (VAS), which consists of a 170-mm line divided into four categories: no pain (0 mm), mild pain (0–54 mm), moderate pain (55–114 mm), and severe pain (115–170 mm). Patients are trained to mark their pain level on this scale. Pain scores are recorded at each treatment stage and used to determine the success or failure of the anesthesia. Khoram-Abad University of Medical Sciences Approved 2025-08-13 Ethics committee of Khorramabad University of Medical Sciences Shafiepoor blvd Khorramabad Lorestan Iran (Islamic Republic of)