A Phase 4 interventional study of Inferior Alveolar Nerve Block With 2% Lidocaine With 1:80,000 Adrenaline and Upfront Buccal Infiltration With 4% Articaine With 1:100,000 Adrenaline in Irreversible Pulpitis and Anesthesia, Local, sponsored by Jamia Millia Islamia. Not yet recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Jamia Millia Islamia · Phase 4, Interventional, and Health services research
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:
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:
Background: Inferior alveolar nerve block (IANB) alone often fails to provide pain-free pulpectomy in mandibular molars with symptomatic irreversible pulpitis (SIP). Supplemental injections are effective as rescue after IANB failure (for example, success of 84% with articaine buccal infiltration and 48% with intraligamentary injection after failed IANB), but no trial has measured their cost or tested whether giving them upfront saves resources. The main costs of failed anaesthesia are dentist and assistant chair time spent re-testing, re-injecting and waiting, abandoned sessions that need a second visit, and patient costs of repeat visits (travel, lost wages, companion time).
Design: Pragmatic, single-centre, parallel-group, three-arm superiority randomised trial (1:1:1) with an embedded within-trial economic evaluation, conducted in the outpatient endodontic and emergency clinics of the Department of Conservative Dentistry and Endodontics, Faculty of Dentistry, Jamia Millia Islamia, New Delhi. Treatment is delivered by faculty and postgraduate residents after a one-day standardisation session. The first 30 patients form an internal pilot.
Interventions: All participants receive topical 20% benzocaine and a conventional IANB with 1.8 mL 2% lidocaine with 1:80,000 adrenaline. Lip numbness is checked at 15 minutes (IANB repeated once if absent). Allocation is revealed only after lip numbness is confirmed. Arm A (control): no supplemental injection; access begins immediately. Arm B: 1.8 mL 4% articaine with 1:100,000 adrenaline buccal infiltration; access after 5 minutes. Arm C: the same buccal infiltration plus intraligamentary injection of 0.2 mL 2% lidocaine with 1:80,000 adrenaline at the mesial and distal roots (0.4 mL total); access after 5 minutes. All arms then follow the same standardised rescue ladder if pain exceeds 54 mm on the 170-mm Heft-Parker VAS: (1) articaine buccal infiltration, (2) intraligamentary injection, (3) intrapulpal injection, (4) session abandoned and rebooked within 7 days; steps already given are skipped. Intraosseous injection is not used.
Randomisation and blinding: Computer-generated permuted blocks of variable size (3 and 6), stratified by operator grade (faculty or resident) and preoperative Aggarwal Index risk category, with central web-based concealment. Patients and operators cannot be blinded; pain is patient-reported using a standard script, an independent time-motion observer records all timestamps and resource use, and the statistician and health economist analyse data with coded arm labels.
Economic evaluation: Bottom-up micro-costing of each patient's resource use (dentist and assistant minutes by grade, cartridges, needles, equipment, overheads and rebooked visits) valued with public-sector unit costs, in Indian rupees at 2026 prices, following the HTAIn reference case where applicable. The primary perspective is the public provider; a societal perspective adds patient costs. The time horizon is the index visit plus any rebooked visit within 7 days. Incremental cost-effectiveness ratios (cost per additional initial-strategy success) and net monetary benefit are estimated with 5,000 non-parametric bootstrap replicates, cost-effectiveness planes and acceptability curves, with sensitivity analyses on unit prices, staff costs, syringe type, rebooked-visit costs and overheads.
Sample size: Assuming 30% success in Arm A and 55% in Arms B and C, two comparisons against control at two-sided alpha 0.025 each and 80% power require 74 per arm; allowing 5% attrition gives 78 per arm (234 in total).
Analysis: Intention to treat. Primary clinical comparisons (Arm B vs A, Arm C vs A) by risk difference with 97.5% confidence intervals and logistic regression adjusted for stratification factors. Pre-specified subgroups: Aggarwal Index category and operator grade.
316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.
This study's planned enrollment of 234 is above the median of 64 across 288 interventional studies indexed under Pulpitis.
Browse Pulpitis studies →Jamia Millia Islamia is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Analgesic or NSAID intake in the previous 12 hours, alcohol use and dental apprehension are recorded and adjusted for in the analysis rather than used as exclusion criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topical 20% benzocaine followed by conventional IANB with 1.8 mL 2% lidocaine with 1:80,000 adrenaline. No supplemental injection; access begins immediately after lip numbness is confirmed. If pain exceeds 54 mm on the HP VAS during access or instrumentation, the standardised rescue ladder is followed: (1) articaine buccal infiltration 1.8 mL, (2) intraligamentary injection 0.2 mL per root, (3) intrapulpal injection, (4) session abandoned and rebooked within 7 days.
Drug: Inferior Alveolar Nerve Block With 2% Lidocaine With 1:80,000 Adrenaline · Procedure: Standardised Stepwise Rescue Anaesthesia Ladder
Topical 20% benzocaine followed by conventional IANB with 1.8 mL 2% lidocaine with 1:80,000 adrenaline. After lip numbness is confirmed, 1.8 mL 4% articaine with 1:100,000 adrenaline is given as buccal infiltration opposite the root apices; access begins after 5 minutes. If pain exceeds 54 mm on the HP VAS, the rescue ladder is followed, skipping steps already given: (2) intraligamentary injection 0.2 mL per root, (3) intrapulpal injection, (4) session abandoned and rebooked within 7 days.
Drug: Inferior Alveolar Nerve Block With 2% Lidocaine With 1:80,000 Adrenaline · Drug: Upfront Buccal Infiltration With 4% Articaine With 1:100,000 Adrenaline · Procedure: Standardised Stepwise Rescue Anaesthesia Ladder
Topical 20% benzocaine followed by conventional IANB with 1.8 mL 2% lidocaine with 1:80,000 adrenaline. After lip numbness is confirmed, 1.8 mL 4% articaine with 1:100,000 adrenaline buccal infiltration, followed by intraligamentary injection of 0.2 mL 2% lidocaine with 1:80,000 adrenaline at the mesial and distal roots (0.4 mL total) with a 30-gauge short needle; access begins after 5 minutes. If pain exceeds 54 mm on the HP VAS, the rescue ladder is followed, skipping steps already given: (3) intrapulpal injection, (4) session abandoned and rebooked within 7 days.
Drug: Inferior Alveolar Nerve Block With 2% Lidocaine With 1:80,000 Adrenaline · Drug: Upfront Buccal Infiltration With 4% Articaine With 1:100,000 Adrenaline · Drug: Upfront Intraligamentary Injection With 2% Lidocaine With 1:80,000 Adrenaline · Procedure: Standardised Stepwise Rescue Anaesthesia Ladder
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.
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.
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.
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.
Initial-Strategy Anaesthetic Success
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.
Time frame: Perioperative
Incremental Cost-Effectiveness Ratio (Public-Provider Perspective)
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.
Time frame: Day 1
Anaesthetic Chair Time
Minutes from the start of the first injection to the end of canal instrumentation (or session abandonment), recorded by an independent time-motion observer.
Time frame: Perioperative
Total Visit Time
Minutes from the patient being seated to leaving the chair, summed across the index visit and any rebooked visit for the same tooth, recorded by an independent time-motion observer.
Time frame: Perioperative
Number of Injections and Anaesthetic Cartridges Used
Count per participant of injections (by type) and local anaesthetic cartridges (by drug), including repeat IANB and rescue injections.
Time frame: Perioperative
Number of Rescue Steps
Number and type of rescue steps of the standardised rescue ladder required per participant.
Time frame: Perioperative
Patient satisfaction
5-Point Likert scale will be used
Time frame: Day 1
Plan to share: Yes — De-identified individual participant data underlying the published results, including clinical outcomes, time-motion and resource-use data, and patient cost data.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning after publication of the primary results and for 5 years thereafter.
Access criteria: Available to researchers who provide a methodologically sound proposal, on reasonable request to the principal investigator, subject to a data-sharing agreement and compliance with the Digital Personal Data Protection Act, 2023.
Start is estimated for Oct 2026; primary completion for May 2027, 7 months later.
Of 15 phase 4 interventional studies under Pulpitis, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 13. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Jamia Millia Islamia