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)

Primary Objective: Compare pre-treatment oral steroids and NSAIDs on success of inferior alveolar nerve block anesthesia in symptomatic irreversible pulpitis of mandibular molars. Secondary Objectives: Determine anesthesia success in control and each drug group (prednisolone, dexamethasone, naproxen, piroxicam, diclofenac). Compare success among groups.

A randomized, double-blind, parallel-group, community-based, pragmatic clinical trial with a control group.

This study will be conducted at the endodontics specialist’s clinic and includes patients referred for endodontic treatment. Sampling will be convenience-based according to inclusion criteria until the required sample size is reached. Eligible participants will be stratified based on gender, age, and pain severity, and then randomly assigned into six groups using the blockrand package in R software. Patients’ pain levels will be recorded at four different stages of the procedure using the Heft-Parker VAS scale, and anesthesia success will be defined based on pain intensity.

Inclusion Criteria: Systemically healthy (ASA I) patients aged 18-60 with symptomatic irreversible pulpitis in mandibular molars, no periapical changes (Periapical Index ≤ 2), able to use pain scale. Exclusion Criteria: Teeth with trauma, open apex, pulp necrosis; systemic disease; immunodeficiency; pregnancy; allergies; recent (within 12h) antibiotic, analgesic or sedative use; long-term medication; unable to consent.

Six groups received oral premedication: naproxen 500 mg, dexamethasone 4 mg, prednisolone 20 mg, piroxicam 20 mg, diclofenac 50 mg, and placebo (dextrose).

Pain during procedure; success of anesthesia

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.

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.

De-identified individual participant data (including age, gender, treatment allocation, and pain scores on Heft-Parker VAS), study protocol, case report forms (CRFs), and statistical analysis plan.

Data will be available within 6 months after completion of the study and publication of the primary results.Data will be available for at least 3 years after publication of the study results.

Access to the data will be granted only to qualified researchers upon written request and approval by the ethics committee.

The data will be available exclusively for research and scientific purposes in the field of dentistry, endodontics, and pain management. Use of the data requires maintaining patient confidentiality, de-identification of all information, and prior approval by the ethics committee. Data sharing for non-scientific or commercial purposes will not be permitted.

Requests should be directed to the principal investigator, Dr. Maryam Dalaei Moghaddam (Faculty Member, Faculty of Dentistry, Lorestan University of Medical Sciences, Khorramabad, Iran).

Upon receiving a written request from a researcher, the application will be reviewed by the university ethics committee. If approved, de-identified data will be provided to the applicant in Excel or SPSS format. Access will be granted only for legitimate scientific and research purposes.