Comparing the effectiveness of a numbing injection with and without an oral painkiller for toothache treatment in lower molar teeth A randomized clinical trial

Comparative evaluation of anaesthetic efficacy of 0.5 percentage bupivacaine with oral diclofenac potassium vs 0.5 percentage bupivacaine on inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular first molar A prospective randomized clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/107927

Enrollment

Registered

2026-04-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Bupivacaine 0.5 percentage plus Diclofenac Potassium 50 mg: Bupivacaine o.5 percentage manufactured from anavin Anawin 0.5 percentage Injection is a prescription medication used as a lo

Eligibility

Inclusion criteria

Inclusion criteria: Healthy patients over 18 years old with Symptomatic irreversible pulpitis in first mandibular molar tooth Patients who had not taken any analgesics within 6 hours before endodontic treatment. Patient willing to participate

Exclusion criteria

Exclusion criteria: History of allergies or sensitivity to Diclofenac Potassium History of known allergies or sensitivity to bupivacaine History of anti-coagulant drug therapy History of central nervous system depressants therapy Pregnant or lactating females, History of active peptic ulcer within the preceding 12 months, Bleeding problems or bleeding disorders Not willing to participate. History of significant medical problems (American Society of Anaesthesiologists class III or higher) History of ventricular arrhythmias, hypotension, hypertension, bradycardia, hemodynamic instability, and cardiovascular collapse

Design outcomes

Primary

Measure	Time frame
The primary outcome is the assessment of anaesthetic efficacy by comparing pain scores between the two groups using the Heft-Parker Visual Analog Scale (VAS). Successful anaesthesia is defined as the absence of pain or mild pain (0-4 on the VAS) during access cavity preparation and the first file placement in the distal canal. Failure is recorded if the patient experiences moderate to severe pain (5 or more than 5 on the VAS) at any point during the procedure.Timepoint: Pain scores will be assessed at the following four time points: 1. Baseline (5 minutes before premedication) 2. 20 minutes after inferior alveolar nerve block administration 3. During access cavity preparation 4. During first file placement in the distal canal of the mandibular first molar Additionally, patients will be followed up at 24-48 hours post-treatment to evaluate flare-ups and post-operative pain.	—

Measure

Time frame

The primary outcome is the assessment of anaesthetic efficacy by comparing pain scores between the two groups using the Heft-Parker Visual Analog Scale (VAS). Successful anaesthesia is defined as the absence of pain or mild pain (0-4 on the VAS) during access cavity preparation and the first file placement in the distal canal. Failure is recorded if the patient experiences moderate to severe pain (5 or more than 5 on the VAS) at any point during the procedure.Timepoint: Pain scores will be assessed at the following four time points: 1. Baseline (5 minutes before premedication) 2. 20 minutes after inferior alveolar nerve block administration 3. During access cavity preparation 4. During first file placement in the distal canal of the mandibular first molar Additionally, patients will be followed up at 24-48 hours post-treatment to evaluate flare-ups and post-operative pain.

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Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactVivek Kalluri

Government dental college and hospital mumbai

abrars79@gmail.com7499423469

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026