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IRCT20260617069848N1 IRCT 2026-07-29 Tabriz University of Medical Sciences Comparison of two adjunctive methods for improving anesthetic success in Root Canal Treatment of teeth with severe pulpal inflammation Evaluation of effect of submucosal injection of Dexamethasone in comparison with buccal infiltration of Articaine for inferior alveolar nerve block success improvement in mandibular first molars with symptomatic irreversible pulpitis: a randomized double-blind clinical trial 2026-08-02 anticipated 96 Recruiting https://irct.ir/trial/91020 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To Randomize the samples and Allocation of patients into two groups, a list containing 96 sequential numbers (Sample size) from 1 to 96 will be provided. Of these 96 numbers, 48 will be assigned to the control group and 48 to the intervention group, and the order of these allocations in the list will be determined completely at random, without following any specific or predictable pattern. For example, the first number may be assigned to the control group, and the subsequent number to the intervention group. This process will continue until all 96 allocations have been assigned. The final group-allocation list will be accessible only to the student responsible for conducting the study. When each eligible patient presents for treatment, the operator will communicate only the patient's enrollment number to the student. The solution corresponding to the assigned group (articaine for the control group or dexamethasone for the intervention group) will then prepared according the allocation corresponding to that number in the pre-prepared list and provided to the operator. Thus, patients will be allocated to the study groups, Blinding description: To ensure blinding, two operators are involved in the study. One operator is responsible for administering the anesthesia and the assigned supplementary intervention (Dexamethasone for intervention group and Articaine for control group), while the second operator performs the root canal treatment and assessed pain intensity throughout the procedure. N/A Symptomatic irreversible pulpitis. Intervention 1: Intervention group: Receiving 1.8 ml of Lidocaine 2% with Epinephrine 1:80000 (Lignocaine 2% with Epinephrine Sahand Daroo pharmaceutical company) and 1ml of Dexamethasone (Dexadic 8mg/2ml Caspian pharmaceutical company), equal to 36mg of Lidocaine and 4 mg of Dexamethasone. Intervention 2: Control group: Receiving 1.8 ml of Lidocaine 2% with 1:80000 Epinephrine (Lignocaine 2% with Epinephrine Sahand Daroo pharmaceutical company) and 1.8 ml of Articaine 4% with Epinephrine 1:200000 (Dentacain 200 with Epinephrine Exir pharmaceutical company), equal to 36mg of Lidocaine and 72mg of Articaine. 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 The final decision regarding data sharing will be made after completion of the study, taking into consideration ethical requirements and participant confidentiality
public Shaghayegh Ghadimi
Faculty of dentistry of Tabriz, University of medical science of Tabriz, Golgasht St., Azadi Blvd.
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3335 5965 Ghadimi.shaghayegh4356@gmail.com Tabriz University of Medical Sciences scientific Shaghayegh Ghadimi
Faculty of Dentistry of Tabriz, University of medical science of Tabriz, Golgasht St., Azadi Blvd.
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3335 5965 Ghadimi.shghayegh4356@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Healthy patients classified as ASA I , ASA II: People without severe systemic diseases that can affect the outcome of anesthesia or treatment Ages between 18-55 y,o: This range was selected in order to reduce the effects of age on neural system's response to anesthesia and inflammation Lower Molars diagnosed with irreversible pulpitis: Based on clinical examinations, it is considered as teeth with spontaneous pain, pain in response to thermal stimulant and sensitivity to cold and electrical test Moderate to severe pain (VASā‰„4): Confirming that the patient needs effective anesthesia Teeth without Abscess, Fistula or widespread infection: Presence of severe infection can have negative impacts on anesthesia's effectiveness and response to treatment Positive response to cold and electrical test: Confirmation of relatively healthy pulpal nerve and presence of active pulpitis Capable of cooperation and fully acknowledging the process of treatment and examinations: Patients should be able and willing to follow the instructions and examinations Informed written consent letter: According to principles of Medical Research Ethics 18 years 55 years Both Allergic reactions to Dexamethasone, Lidocaine, Articaine or Epinephrine: including previous or known reactions Uncontrolled systemic diseases: Including poorly controlled type 1 and 2 diabetes, cardiovascular, Liver, Renal diseases or Immunodeficiencies that can affect the process of treatment Pregnant or nursing women: Considering the limitation of using drugs in these two groups Consumption of Corticosteroids or potent Anti-Inflammations in recent two weeks: In order to prevent the systemic effects of drug interference on the results Presence of Acute infection, Abscess or active Fistula at the site of treatment: Can reduce the effectiveness of anesthesia Teeth with root or crown fracture that require complicated treatments: Confirming the integrity of structure and reducing the confounding factors in analysis of anesthesia History of unsuccessful Endodontic treatment of the intended tooth: Other factors might be involved in failure Patients that are not capable to cooperate or follow the instructions: Including patients with mental disorders or severe physical disability Consumption of Narcotics or Alcohol: Can affect the sensitivity to pain and response to anesthesia Patients under medications or particular psychological treatments that can affect the sensitivity to pain and response to anesthesia: For example Antidepressant or Anxiolytic drugs Patients with previous trauma to Molars Calcification of pulp and root canals Patients with Contraindications (Relative or Absolute) to Dexamethasone Patients that have consumed painkillers in the recent 12 hours K04.0 Pulpitis Treatment - Drugs Treatment - Drugs Intervention group: Receiving 1.8 ml of Lidocaine 2% with Epinephrine 1:80000 (Lignocaine 2% with Epinephrine Sahand Daroo pharmaceutical company) and 1ml of Dexamethasone (Dexadic 8mg/2ml Caspian pharmaceutical company), equal to 36mg of Lidocaine and 4 mg of Dexamethasone Control group: Receiving 1.8 ml of Lidocaine 2% with 1:80000 Epinephrine (Lignocaine 2% with Epinephrine Sahand Daroo pharmaceutical company) and 1.8 ml of Articaine 4% with Epinephrine 1:200000 (Dentacain 200 with Epinephrine Exir pharmaceutical company), equal to 36mg of Lidocaine and 72mg of Articaine Percentage of patients with successful anesthesia during the root canal treatment. Timepoint: During the preparation of access cavity and initial instrumentation of root canal. Method of measurement: Pain intensity reported by patient and lack of need for repetition of the administration of anesthesia. Pain intensity during treatment based on VAS. Timepoint: During the preparation of access cavity and initial instrumentation of root canal. Method of measurement: Visual Analogue Scale in range of 0 to 10. Pain intensity during treatment based on ESM. Timepoint: During the preparation of access cavity and initial instrumentation of root canal. Method of measurement: Observing signs of ESM including opening or closing eyes, making sounds, body motions. 1 score for each one. Need for repetition of anesthesia. Timepoint: During root canal treatment. Method of measurement: The requirement for re-administration of anesthesia by the operator. recorded as a Yes/No. Tabriz University of Medical Sciences Approved 2026-06-08 Ethics committee of Shiraz University of Medical Sciences University of medical science of Tabriz, Golgasht St., Azadi Blvd. Tabriz East Azarbaijan Iran (Islamic Republic of)