Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Eligibility

Primary outcome measure(s)

• Initial-Strategy Anaesthetic Success — Perioperative
  Proportion of participants in whom access cavity preparation, pulp extirpation and canal instrumentation are completed with no or mild pain (Heft-Parker visual analogue scale \[HP VAS\] 54 mm or less on the 170-mm scale, where 0 = no pain and 170 = worst pain) and without any rescue injection.
• Incremental Cost-Effectiveness Ratio (Public-Provider Perspective) — Day 1
  Difference in mean cost per patient divided by the difference in proportion of initial-strategy success, for Arm B vs Arm A and Arm C vs Arm A. Costs are micro-costed per patient (dentist and assistant time, cartridges, needles, equipment, overheads and rebooked visits) in Indian rupees at 2026 prices using public-sector unit costs. Reported as INR per additional initial-strategy success, with net monetary benefit across willingness-to-pay values of INR 0 to 2,000 per additional success.

Trial sites (1)

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