Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial

NCT07130760 | Recruiting DMC

• 1 other identifier: ILA VS AINB PULP
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

This multicenter randomized trial compares the clinical effectiveness of intraligamentary injection versus inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis in mandibular molars. The goal is to determine which technique provides better pain control during endodontic treatment.

Conditions

Symptomatic Irreversible Pulpitis (SIP); Dental Pain; Inferior Alveolar Nerve Block Failure; Local Anesthesia

Keywords

Inferior alveolar nerve block; Pulpitis Mandibular molars; Emergency dental treatment; Symptomatic irreversible pulpitis; Randomized clinical trial; Endodontics; Dental pain; Local anesthesia; Intraligamentary anesthesia

Outcome Measures

Primary Outcomes (1)

• Pain during endodontic access

  Pain intensity experienced by the patient during endodontic access after the assigned anesthetic technique.

  Immediately after access cavity preparation (within 30 minutes of anesthesia)

Secondary Outcomes (4)

• Need for supplementary anesthesia

  During access or initial root canal instrumentation (within first 45 minutes)

• Patient satisfaction immediately after treatment

  End of visit (within 1 hour)

• Postoperative pain at 7 days

  Day 7 post-treatment

• Patient satisfaction at 7 days

  Day 7 post-treatment

Study Arms (2)

Intraligamentary Injection Group

EXPERIMENTAL

Patients in this arm will receive intraligamentary anesthesia prior to endodontic access.

Procedure: Intraligamentary Injection

Inferior Alveolar Nerve Block Group

ACTIVE COMPARATOR

Patients in this arm will receive standard inferior alveolar nerve block prior to endodontic access.

Procedure: Inferior Alveolar Nerve Block

Interventions

Intraligamentary Injection PROCEDURE

Intraligamentary local anesthesia will be administered using a standard dental syringe with 2% lidocaine and 1:100,000 epinephrine.

Also known as: Intraligamental anesthesia (ILA), Periodontal ligament injection (PDL injection), Intraligamentary anesthetic technique

Intraligamentary Injection Group

Inferior Alveolar Nerve Block PROCEDURE

Inferior alveolar nerve block will be performed with 2% lidocaine and 1:100,000 epinephrine using the conventional technique.

Also known as: Inferior alveolar nerve anesthesia, Inferior dental block

Inferior Alveolar Nerve Block Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Presenting with symptomatic irreversible pulpitis in a mandibular molar
• Vital response to cold testing
• Ability to understand and provide informed consent
• Available for follow-up and data collection

You may not qualify if:

• Known allergy to lidocaine or epinephrine
• Pregnancy or breastfeeding
• Use of analgesics or anti-inflammatory drugs in the previous 6 hours
• Non-vital or previously treated teeth
• Significant systemic disease (ASA III or above)
• History of psychiatric or neurological disorders affecting pain perception

Sponsors & Collaborators

• Aula Dental Avanzada: lead

Study Sites (2)

Clínica Dental 4

Ferrol, A coruña, 15402, Spain

RECRUITING

Clínica Dental Esteve

Alicante, Alicante, 03001, Spain

RECRUITING

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Guillem Esteve-Pardo, PhD

CONTACT

34965215755; guillem@clinicaesteve.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of which anesthetic technique is administered. Operators cannot be blinded due to the nature of the procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - DDS, PhD (Bioengineering)

Model Details: Participants will be randomly assigned to receive either intraligamentary injection or inferior alveolar nerve block prior to endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: August 19, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)