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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)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250815066862N1
Enrollment
210
Registered
2025-08-26
Start date
2025-09-06
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Steroidal and Non-Steroidal Anti-Inflammatory , Symptomatic Irreversible Pulpiti.

Interventions

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

Sponsors

Khoram-Abad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Maryam Dalaei Moghaddam

Khoram-Abad University of Medical Sciences

maryam.dalaei@yahoo.com+98 66 3320 7826

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026