Assessment of Local Anaesthesia Effectiveness in Symptomatic Irreversible Pulpitis

NCT06862570 | Completed Phase 2 FDA Drug

• 1 other identifier: LOCAL ANAESTHESIA
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Symptomatic Irreversible Pulpitis

Keywords

Lignocaine, Articaine and Supplemental Buccal Infiltration

Outcome Measures

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

  5-10 minutes after administrating supplemental buccal infiltration

Study Arms (2)

2% LIGNOCAINE WITH EPINEPHRINE

EXPERIMENTAL

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)

4% ARTICAINE WITH EPINEPHRINE

EXPERIMENTAL

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

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

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

Also known as: HD caine Plus

2% LIGNOCAINE WITH EPINEPHRINE

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

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

Also known as: Orabloc

4% ARTICAINE WITH EPINEPHRINE

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• 28 Military Dental Centre Lahore: lead

Study Sites (1)

Zahra Zubir

Lahore, Punjab Province, 042, Pakistan

Location

Related Publications (6)

• 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.

  PMID: 29397214 BACKGROUND

• 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.

  PMID: 35656683 BACKGROUND

• Oghabi N, Renton T. Optimizing Local Anaesthetic Practice: Addressing Misconceptions and Minimizing Anaesthetic Failures. Dent Update. 2022;49(1):32-38.

  BACKGROUND

• 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.

  PMID: 34274944 BACKGROUND

• 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.

  PMID: 31302768 BACKGROUND

• 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.

  PMID: 34137527 BACKGROUND

MeSH Terms

Interventions

Lidocaine; Epinephrine; Carticaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zahra Zubair, BDS

  28 Military Dental Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Zahra Zubair

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 6, 2025
• Study Start: December 19, 2022
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: 6 months after publication
• Access Criteria: zahra\ zubair@hotmail.com

Locations

PA (1)