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

NCT ID: NCT07130760

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-20

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Symptomatic irreversible pulpitis in mandibular molars presents a clinical challenge due to the difficulty in achieving profound anesthesia. This prospective, randomized, controlled clinical trial evaluates two anesthetic techniques-intraligamentary injection (ILA) versus inferior alveolar nerve block (IANB)-to compare their efficacy in eliminating pain during endodontic access. Patients will be enrolled from multiple dental centers following standardized inclusion and exclusion criteria. Pain will be assessed using validated scales. Statistical analysis will be conducted to determine significant differences in anesthetic success between groups.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be unaware of which anesthetic technique is administered. Operators cannot be blinded due to the nature of the procedures.

Study Groups

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Intraligamentary Injection Group

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

Group Type EXPERIMENTAL

Intraligamentary Injection

Intervention Type PROCEDURE

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

Inferior Alveolar Nerve Block Group

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

Group Type ACTIVE_COMPARATOR

Inferior Alveolar Nerve Block

Intervention Type PROCEDURE

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

Interventions

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Intraligamentary Injection

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

Intervention Type PROCEDURE

Inferior Alveolar Nerve Block

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

Intervention Type PROCEDURE

Other Intervention Names

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Intraligamental anesthesia (ILA) Periodontal ligament injection (PDL injection) Intraligamentary anesthetic technique Inferior alveolar nerve anesthesia Inferior dental block

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aula Dental Avanzada

OTHER

Sponsor Role lead

Responsible Party

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Guillem Esteve-Pardo

Principal Investigator - DDS, PhD (Bioengineering)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clínica Dental 4

Ferrol, A coruña, Spain

Site Status RECRUITING

Clínica Dental Esteve

Alicante, Alicante, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Guillem Esteve-Pardo, PhD

Role: CONTACT

34965215755

Facility Contacts

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Pedro Barreiro-Gabeiras, DDS

Role: primary

34981358375

Guillem Esteve-Pardo, PhD

Role: primary

34965215755

Other Identifiers

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ILA VS AINB PULP

Identifier Type: -

Identifier Source: org_study_id

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