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Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Sponsor: Jamia Millia Islamia
Summary
The goal of this clinical trial is to learn whether giving extra (supplemental) local anaesthetic injections at the start of treatment, rather than only after the standard injection fails, makes numbing of painful lower molar teeth more successful and lowers the overall cost of care in adults with symptomatic irreversible pulpitis (a severe toothache caused by an inflamed nerve) attending a public-sector dental hospital in India. The main questions it aims to answer are: * Does adding an articaine buccal infiltration, alone or together with an intraligamentary injection, to the standard inferior alveolar nerve block (IANB) increase the number of patients who can have their root canal treatment started without pain and without rescue injections? * What is the extra cost per additional successful anaesthesia of each upfront strategy compared with IANB followed by rescue injections only when needed? Researchers will compare three groups: IANB with rescue injections only if needed (control), IANB plus upfront articaine buccal infiltration, and IANB plus upfront articaine buccal infiltration and intraligamentary injection. Participants will: * Receive a standard IANB, followed (depending on their group) by one or two additional injections before treatment starts * Rate their pain during access and cleaning of the tooth on a visual analogue scale; rescue injections will be given if pain is moderate or severe * Have the time taken and the injections used recorded by an independent observer * Answer a short questionnaire about travel, time and earnings lost for each visit * Receive a phone call 24 hours later about pain and any side effects
Official title: Cost-Effectiveness of Upfront Articaine Buccal Infiltration, Alone or Combined With Intraligamentary Injection, Versus Inferior Alveolar Nerve Block With Rescue in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Pragmatic, Single-Centre, Three-Arm Randomised Trial With Embedded Economic Evaluation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
234
Start Date
2026-10-30
Completion Date
2027-06-15
Last Updated
2026-10-30
Healthy Volunteers
No
Conditions
Interventions
Inferior Alveolar Nerve Block With 2% Lidocaine With 1:80,000 Adrenaline
Conventional IANB with 1.8 mL 2% lidocaine with 1:80,000 adrenaline, 27-gauge long needle, injected over about 60 seconds after 60 seconds of topical 20% benzocaine. Lip numbness checked at 15 minutes; the IANB is repeated once if absent. Given to all participants before allocation is revealed.
Upfront Buccal Infiltration With 4% Articaine With 1:100,000 Adrenaline
1.8 mL 4% articaine with 1:100,000 adrenaline given as buccal infiltration opposite the root apices of the study tooth after lip numbness from the IANB is confirmed and before access; access begins after 5 minutes.
Upfront Intraligamentary Injection With 2% Lidocaine With 1:80,000 Adrenaline
Intraligamentary injection of 0.2 mL 2% lidocaine with 1:80,000 adrenaline at each of the mesial and distal roots (0.4 mL total) using a 30-gauge short needle with firm back-pressure, given after the articaine buccal infiltration and before access; access begins after 5 minutes.
Standardised Stepwise Rescue Anaesthesia Ladder
Triggered when the patient reports pain above 54 mm on the 170-mm Heft-Parker VAS, or asks to stop, during access or instrumentation. Steps already given in the allocated arm are skipped: (1) articaine buccal infiltration 1.8 mL; (2) intraligamentary injection 0.2 mL per root; (3) intrapulpal injection 0.2-0.4 mL under pressure; (4) session abandoned, analgesic prescribed, temporary dressing placed and visit rebooked within 7 days. Intraosseous injection is not used. Total dose stays within weight-based maximum limits.
Locations (1)
Jamia Millia Islamia
New Delhi, National Capital Territory of Delhi, India