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CompletedNCT06862570LA AGENTSUpdated Mar 6, 2025

Assessment of Local Anaesthesia Effectiveness in Symptomatic Irreversible Pulpitis

A Phase 2 interventional study of 2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml) and 4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml) in Symptomatic Irreversible Pulpitis, sponsored by 28 Military Dental Centre Lahore. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-06.

Sponsored by 28 Military Dental Centre Lahore · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2023, 3 years 4 months ago, and no results have been posted to the registry.
  • Registered 2 years 2 months after the study started (first participant enrolled Dec 2022, registered Feb 2025).
Phase
Phase 2
Study type
Interventional
Enrollment
123
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This study aims to evaluate the comparative efficacy of two different local anaesthetic agents for supplemental buccal infiltration after a failed inferior alveolar nerve block in achieving profound pulpal anaesthesia for symptomatic irreversible pulpitis using 2% lignocaine and 4% articaine with vasoconstrictor epinephrine.

Alternate hypothesis:

There is a mean difference in local anaesthesia effectiveness of 2% lignocaine and 4% articaine containing epinephrine when used for buccal infiltration in pulpectomy of symptomatic irreversible pulpitis of mandibular posterior teeth after a failed inferior alveolar nerve block

Read the detailed description

Patients diagnosed with symptomatic irreversible pulpitis are included in this study. Teeth will be divided into two groups after a failed inferior alveolar nerve block using 2% lignocaine containing 1:100,000 epinephrine. A sample size of 123, with the first group consisting of 62 patients, 2 cartridges of 32mg of 2% lignocaine with 1:100,000 epinephrine will be used for supplemental buccal infiltration. In group 2 of 61 patients, 40mg of 4% articaine with 1:100,000 epinephrine will be used. During the root canal treatment, a subjective assessment of lip anesthesia is recorded. An electric pulp tester is used for the evaluation of the presence or absence of pulpal anesthesia. A verbal analogue scale is also used to evaluate the presence or absence of pain.

After taking a brief history, informed consent will be taken. A rubber dam will be used. Electric pulp tester will be used on the control contralateral tooth, the experimental tooth preoperatively; after giving nerve block and achieving Lip numbness, the experimental tooth will again be evaluated with Electric pulp tester. An access cavity will be made. If there is still no pulpal anesthesia, supplemental anesthesia will be administered and Electric pulp tester will be used again.

A questionnaire containing a numerical rating scale will be given to each patient to record the intensity of pain felt after giving supplemental anesthesia.

02

Conditions studied

  • Symptomatic Irreversible Pulpitis

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Keywords

  • Lignocaine, Articaine and Supplemental Buccal Infiltration
03

In context

Pulpitis

302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.

This study's enrollment of 123 is above the median of 62 across 275 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

28 Military Dental Centre Lahore is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Patients with ages ranging from 18-to 55 years
  2. Male/ Female
  3. Mandibular posterior teeth with symptomatic irreversible pulpitis
  4. Ability to understand the use of the pain scale
  5. Patients with adequate oral hygiene and willing to participate in the study

Exclusion criteria

Exclusion Criteria:

  1. Any type of medication consumed before treatment
  2. Patients who do not show profound lip numbness after giving inferior alveolar block
  3. Periapical pathologies ( periapical abscess, sinus tract, periapical cyst, pulpal necrosis)
  4. External resorption
  5. Unfavorable location of the tooth, internal ankylosis, trismus, severe tooth malposition.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
123 participants (actual)

Study arms

  • Experimental
    2% LIGNOCAINE WITH EPINEPHRINE

    1.8 ml of 2% Lignocaine with 1:100,000 epinephrine (36 mg/ml Lignocaine HCL, epinephrine bitartrate 0.0324 mg/ml)

    Drug: 2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml)

  • Experimental
    4% ARTICAINE WITH EPINEPHRINE

    1.7 ml of 4% Articaine with 1:100,000 epinephrine (40mg/ml Articaine HCL, epinephrine bitartrate 0.018mg/ml)

    Drug: 4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml)

Interventions

  • Drug2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml)

    2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml)

    Also known as: HD caine Plus

  • Drug4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml)

    4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml)

    Also known as: Orabloc

06

What researchers measure

Primary outcomes

  1. Assessment of Local anaesthsia effectiveness in symptomatic irreversible pulpitis after afailed inferior alveolar nerve block using supplemental buccal infiltration

    Numeric Rating scale to assess absence or presence of pain after supplemental buccal infiltration

    Time frame: 5-10 minutes after administrating supplemental buccal infiltration

07

Study locations

1 site
  • Zahra Zubir
    Lahore, Punjab 042, Pakistan
08

References and documents

Publications

  • Shapiro MR, McDonald NJ, Gardner RJ, Peters MC, Botero TM. Efficacy of Articaine versus Lidocaine in Supplemental Infiltration for Mandibular First versus Second Molars with Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial. J Endod. 2018 Apr;44(4):523-528. doi: 10.1016/j.joen.2017.10.003. Epub 2018 Feb 1. PubMed 29397214 ↗
  • Janiani P, Gurunathan D. Effectiveness of Pre-administered Natural Sweet-tasting Solution for Decreasing Pain Associated with Dental Injections in Children: A Split-mouth Randomized Controlled Trial. J Contemp Dent Pract. 2021 Dec 1;22(12):1434-1437. PubMed 35656683 ↗
  • Oghabi N, Renton T. Optimizing Local Anaesthetic Practice: Addressing Misconceptions and Minimizing Anaesthetic Failures. Dent Update. 2022;49(1):32-38.
  • Martin E, Nimmo A, Lee A, Jennings E. Articaine in dentistry: an overview of the evidence and meta-analysis of the latest randomised controlled trials on articaine safety and efficacy compared to lidocaine for routine dental treatment. BDJ Open. 2021 Jul 17;7(1):27. doi: 10.1038/s41405-021-00082-5. PubMed 34274944 ↗
  • Dianat O, Mozayeni MA, Layeghnejad MK, Shojaeian S. The efficacy of supplemental intraseptal and buccal infiltration anesthesia in mandibular molars of patients with symptomatic irreversible pulpitis. Clin Oral Investig. 2020 Mar;24(3):1281-1286. doi: 10.1007/s00784-019-03006-8. Epub 2019 Jul 13. PubMed 31302768 ↗
  • Khan Q, Noor N, Anayat N, Khan TS, Ahmed M. Comparison Of Anaesthetic Efficacy Of Articaine And Lidocaine In Nonsurgical Endodontic Treatment Of Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis. A Randomized Clinical Trial. J Ayub Med Coll Abbottabad. 2021 Apr-Jun;33(2):192-197. PubMed 34137527 ↗

Individual participant data

Plan to share: Yes — Gender, tooth no.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06862570
Lead sponsor
28 Military Dental Centre Lahore
Responsible party
Zahra Zubair (Dr Zahra Zubair, 28 Military Dental Centre Lahore) — Principal investigator
First posted
Mar 6, 2025
Start date
Dec 19, 2022
Primary completion
May 19, 2023
Completion
May 19, 2023
Last update
Mar 6, 2025

Study contacts

Zahra Zubair, BDS
principal investigator · 28 Military Dental Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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