Irreversible PulpitisPhase 4UPFRONT-SIPNCT07907120
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
A Phase 4 study testing Inferior Alveolar Nerve Block With 2% Lidocaine With 1:80,000 Adrenaline, Upfront Buccal Infiltration With 4% Articaine With 1:100,000 Adrenaline and Upfront Intraligamentary Injection With 2% Lidocaine With 1:80,000 Adrenaline in people with Irreversible Pulpitis and Anesthesia, Local, run by Jamia Millia Islamia at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irreversible Pulpitis, Anesthesia, Local
- What is being tested?
- Inferior Alveolar Nerve Block With 2% Lidocaine With 1:80,000 Adrenaline, Upfront Buccal Infiltration With 4% Articaine With 1:100,000 Adrenaline and Upfront Intraligamentary Injection With 2% Lidocaine With 1:80,000 Adrenaline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteIndia
- Study dates
- 30 Oct 2026to 15 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older, ASA physical status I or II
- Mandibular first or second molar with symptomatic irreversible pulpitis: spontaneous or lingering pain and a prolonged, intense response to cold testing, confirmed by bleeding pulp tissue on access
- Moderate to severe preoperative pain (Heft-Parker visual analogue scale above 54 mm on the 170-mm scale)
- Restorable tooth planned for root canal treatment
- Able to rate pain on the Heft-Parker visual analogue scale and to give written informed consent
Who cannot join
- Allergy or sensitivity to amide local anaesthetics or sulphites
- Pregnancy or lactation
- Uncontrolled hypertension, recent myocardial infarction or other conditions contraindicating adrenaline
- Anticoagulant therapy or bleeding disorders
- Necrotic pulp (no response to cold testing) or acute apical abscess with swelling
- Previous pulpal access on the study tooth
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Jamia Millia Islamia
New Delhi, National Capital Territory of Delhi, 110025
Vivek Aggarwal, 01126981818, drvivekaggarwal@gmail.com
About this study
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
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:
Read more
- 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
Read the detailed description
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.
- Conditions
- Irreversible Pulpitis, Anesthesia, Local
- Being tested
- Inferior Alveolar Nerve Block With 2% Lidocaine With 1:80,000 Adrenaline, Upfront Buccal Infiltration With 4% Articaine With 1:100,000 Adrenaline, Upfront Intraligamentary Injection With 2% Lidocaine With 1:80,000 Adrenaline, Standardised Stepwise Rescue Anaesthesia Ladder
- Keywords
- Inferior Alveolar Nerve Block, Articaine, Buccal Infiltration, Intraligamentary Injection, Supplemental Anesthesia, Cost-Effectiveness Analysis, Pragmatic Clinical Trial, Endodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior Alveolar Nerve Block With 2% Lidocaine With 1:80,000 AdrenalineDrug
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 AdrenalineDrug
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 AdrenalineDrug
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 LadderProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Arm A: IANB With Stepwise Rescue (Control) | Active comparator | 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. Receives: Drug: Inferior Alveolar Nerve Block With 2% Lidocaine With 1:80,000 Adrenaline; Procedure: Standardised Stepwise Rescue Anaesthesia Ladder |
| Arm B: IANB + Upfront Articaine Buccal Infiltration | Experimental | 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. Receives: 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 |
| Arm C: IANB + Upfront Intraligamentary Injection + Articaine Buccal Infiltration | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Perioperative
Number of Rescue Steps
Number and type of rescue steps of the standardised rescue ladder required per participant.
Measured: Perioperative
Patient satisfaction
5-Point Likert scale will be used
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, single-centre, three-arm parallel-group superiority randomised trial (1:1:1) with an embedded within-trial economic evaluation. Arm A (IANB with stepwise rescue, control) is compared with Arm B (IANB + upfront articaine buccal infiltration) and Arm C (IANB + upfront articaine buccal infiltration + intraligamentary injection). All arms follow the same standardised rescue ladder.
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jamia Millia Islamia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vivek Aggarwal, Jamia Millia Islamia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907120
- Sponsor's protocol ID
- Supplemental Anaesthesia cost
- Acronym
- UPFRONT-SIP
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results, including clinical outcomes, time-motion and resource-use data, and patient cost data.
Publications
Kanaa MD, Whitworth JM, Meechan JG. A prospective randomized trial of different supplementary local anesthetic techniques after failure of inferior alveolar nerve block in patients with irreversible pulpitis in mandibular teeth. J Endod. 2012 Apr;38(4):421-5. doi: 10.1016/j.joen.2011.12.006. Epub 2012 Feb 2.
PubMed 22414822
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07907120
- Acronym / sponsor ID
- UPFRONT-SIP / Supplemental Anaesthesia cost
- Conditions
- Irreversible Pulpitis, Anesthesia, Local
- Keywords
- Inferior Alveolar Nerve Block, Articaine, Buccal Infiltration, Intraligamentary Injection, Supplemental Anesthesia, Cost-Effectiveness Analysis, Pragmatic Clinical Trial, Endodontics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Jamia Millia IslamiaUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Pragmatic, single-centre, three-arm parallel-group superiority randomised trial (1:1:1) with an embedded within-trial economic evaluation. Arm A (IANB with stepwise rescue, control) is compared with Arm B (IANB + upfront articaine buccal infiltration) and Arm C (IANB + upfront articaine buccal infiltration + intraligamentary injection). All arms follow the same standardised rescue ladder.
| Arm | Type | Receives |
|---|---|---|
| Arm A: IANB With Stepwise Rescue (Control) | Active comparator | Drug: Inferior Alveolar Nerve Block With 2% Lidocaine With 1:80,000 Adrenaline, Procedure: Standardised Stepwise Rescue Anaesthesia LadderTopical 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. |
| Arm B: IANB + Upfront Articaine Buccal Infiltration | Experimental | 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 LadderTopical 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. |
| Arm C: IANB + Upfront Intraligamentary Injection + Articaine Buccal Infiltration | Experimental | 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 LadderTopical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older, ASA physical status I or II
- Mandibular first or second molar with symptomatic irreversible pulpitis: spontaneous or lingering pain and a prolonged, intense response to cold testing, confirmed by bleeding pulp tissue on access
- Moderate to severe preoperative pain (Heft-Parker visual analogue scale above 54 mm on the 170-mm scale)
- Restorable tooth planned for root canal treatment
- Able to rate pain on the Heft-Parker visual analogue scale and to give written informed consent
Key exclusion criteria (7 listed)
- Allergy or sensitivity to amide local anaesthetics or sulphites
- Pregnancy or lactation
- Uncontrolled hypertension, recent myocardial infarction or other conditions contraindicating adrenaline
- Anticoagulant therapy or bleeding disorders
- Necrotic pulp (no response to cold testing) or acute apical abscess with swelling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inferior Alveolar Nerve Block With 2% Lidocaine With 1:80,000 AdrenalineConventional 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. | Drug | Arm A: IANB With Stepwise Rescue (Control), Arm B: IANB + Upfront Articaine Buccal Infiltration, Arm C: IANB + Upfront Intraligamentary Injection + Articaine Buccal Infiltration |
| Upfront Buccal Infiltration With 4% Articaine With 1:100,000 Adrenaline1.8 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. | Drug | Arm B: IANB + Upfront Articaine Buccal Infiltration, Arm C: IANB + Upfront Intraligamentary Injection + Articaine Buccal Infiltration |
| Upfront Intraligamentary Injection With 2% Lidocaine With 1:80,000 AdrenalineIntraligamentary 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. | Drug | Arm C: IANB + Upfront Intraligamentary Injection + Articaine Buccal Infiltration |
| Standardised Stepwise Rescue Anaesthesia LadderTriggered 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. | Procedure or surgery | Arm A: IANB With Stepwise Rescue (Control), Arm B: IANB + Upfront Articaine Buccal Infiltration, Arm C: IANB + Upfront Intraligamentary Injection + Articaine Buccal Infiltration |
Primary outcome
Initial-Strategy Anaesthetic Success
Time frame: 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)
Time frame: 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.
5 secondary outcomes
Anaesthetic Chair Time
Time frame: Perioperative
Total Visit Time
Time frame: Perioperative
Number of Injections and Anaesthetic Cartridges Used
Time frame: Perioperative
Number of Rescue Steps
Time frame: Perioperative
Patient satisfaction
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 22414822Kanaa MD, Whitworth JM, Meechan JG. A prospective randomized trial of different supplementary local anesthetic techniques after failure of inferior alveolar nerve block in patients with irreversible pulpitis in mandibular teeth. J Endod. 2012 Apr;38(4):421-5. doi: 10.1016/j.joen.2011.12.006. Epub 2012 Feb 2.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results, including clinical outcomes, time-motion and resource-use data, and patient cost data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inferior Alveolar Nerve Block With 2% Lidocaine With 1:80,000 Adrenaline, Upfront Buccal Infiltration With 4% Articaine With 1:100,000 Adrenaline and Upfront Intraligamentary Injection With 2% Lidocaine With 1:80,000 Adrenaline in people with Irreversible Pulpitis and Anesthesia, Local, run by Jamia Millia Islamia at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vivek Aggarwal (01126981818, drvivekaggarwal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial-Strategy Anaesthetic Success (time frame: Perioperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07907120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.