Articaine Versus Lidocaine for Supplemental Buccal Infiltration in Lower First Molars With Irreversible Pulpitis

NCT07869394 | Completed Phase 4

• 1 other identifier: ARTLID-SUPP-IANB-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Local anesthetic is used to numb a tooth before a root canal treatment. In lower back teeth with irreversible pulpitis (a painful, inflamed tooth nerve), the standard numbing injection near the jaw nerve, called an inferior alveolar nerve block, often does not numb the tooth enough. When this happens, patients may feel pain during treatment, and dentists often give an extra injection beside the tooth. This study compares two numbing medicines used for that extra injection: 4% articaine and 2% lidocaine, both with epinephrine. Articaine is a newer medicine that may pass through bone more easily, but it is not clear whether it works better than lidocaine in this situation. Adults aged 18 to 50 with a painful lower first molar needing a root canal first receive the standard nerve block with lidocaine. Patients who still feel pain when the dentist begins opening the tooth then receive an extra injection beside the tooth, with either articaine or lidocaine. Which medicine is given is decided by chance, and neither the patient nor the dentist knows which one it is.

Conditions

Irreversible Pulpitis; Failed Inferior Alveolar Nerve Block

Keywords

Articaine; Lidocaine; Supplemental Infiltration; Buccal Infiltration; Inferior Alveolar Nerve Block

Outcome Measures

Primary Outcomes (1)

• Success of Pulpal Anesthesia With Supplemental Buccal Infiltration

  Proportion of participants in whom access cavity preparation and initial instrumentation were completed without pain after supplemental buccal infiltration. Success was defined as no reported pain and no need for additional anesthesia. Pain was assessed using the Heft-Parker Visual Analog Scale (0-170 mm), with higher scores indicating greater pain intensity.

  Immediately after initial instrumentation during the single treatment visit.

Secondary Outcomes (1)

• Pain Intensity During Access Cavity Preparation (Heft-Parker VAS)

  Immediately after completion of access cavity preparation and initial instrumentation during the single treatment visit.

Study Arms (2)

Articaine Supplemental Buccal Infiltration

EXPERIMENTAL

All participants first receive an inferior alveolar nerve block with 1.8 mL of 2% lidocaine with 1:100,000 epinephrine. Participants who report pain during access cavity preparation (failed block) receive a supplemental buccal infiltration next to the mandibular first molar with 1.8 mL of 4% articaine with 1:100,000 epinephrine, using a 30-gauge short needle. Anesthetic success is judged by whether access preparation and initial instrumentation can be completed without pain.

Drug: Articaine 4% with epinephrine 1:100,000

Lidocaine Supplemental Buccal Infiltration

ACTIVE COMPARATOR

All participants first receive an inferior alveolar nerve block with 1.8 mL of 2% lidocaine with 1:100,000 epinephrine. Participants who report pain during access cavity preparation (failed block) receive a supplemental buccal infiltration next to the mandibular first molar with 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, using a 30-gauge short needle. Anesthetic success is judged by whether access preparation and initial instrumentation can be completed without pain.

Drug: Lidocaine 2% with Epinephrine 1:100,000

Interventions

Articaine 4% with epinephrine 1:100,000 DRUG

Supplemental buccal infiltration of 1.8 mL of 4% articaine with 1:100,000 epinephrine, given next to the mandibular first molar with a standard aspirating dental syringe and a 30-gauge short needle. It is given only to participants who report pain during access cavity preparation after an inferior alveolar nerve block with 2% lidocaine.

Also known as: Articaine Hydrochloride, Articaine with Adrenaline

Articaine Supplemental Buccal Infiltration

Lidocaine 2% with Epinephrine 1:100,000 DRUG

Supplemental buccal infiltration of 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, given next to the mandibular first molar with a standard aspirating dental syringe and a 30-gauge short needle. It is given only to participants who report pain during access cavity preparation after an inferior alveolar nerve block with 2% lidocaine.

Also known as: Lidocaine Hydrochloride, Lignocaine with Adrenaline

Lidocaine Supplemental Buccal Infiltration

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 50 years
• Systemically healthy (ASA I or II)
• Mandibular first molar with symptomatic irreversible pulpitis, diagnosed by a history of spontaneous pain, prolonged response to cold testing (EndoFrost), and bleeding pulpal tissue on access cavity preparation
• Radiographic absence of periapical radiolucency, apart from widening of the periodontal ligament
• Able to provide written informed consent

You may not qualify if:

• Pregnancy or lactation
• History of allergy to amide-type local anesthetics
• Acute apical abscess
• Necrotic pulp
• Periodontal pathology
• Retreatment cases
• Use of analgesics or anti-inflammatory drugs, or other medications that could alter pain perception, within 12 hours before treatment

Sponsors & Collaborators

• Rehman Medical Institute - RMI: lead

Study Sites (1)

Rehman Medical Institute

Peshawar, Pakistan

Location

MeSH Terms

Interventions

Carticaine; Epinephrine; Lidocaine

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Anesthetic cartridges were masked and coded by a second investigator not involved in the clinical procedures. Allocation was concealed in sequentially numbered, opaque, sealed envelopes opened by an independent assistant. The operator and patient did not know which anesthetic was used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Trainee

Model Details: Two-arm parallel trial. All participants first receive an inferior alveolar nerve block with 2% lidocaine. Those who experience pain during access preparation are randomized to a supplemental buccal infiltration with either 4% articaine or 2% lidocaine, each with 1:100,000 epinephrine.

Study Record Dates

• First Submitted: October 2, 2026
• First Posted: October 9, 2026
• Study Start: March 3, 2026
• Primary Completion: August 7, 2026
• Study Completion: August 27, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)