Menu
Recruiting NCT07130760

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

No phase Interventional Symptomatic Irreversible Pulpitis (SIP) Dental Pain Inferior Alveolar Nerve Block Failure Local Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intraligamentary Injection, Inferior Alveolar Nerve Block.
Who it may be relevant to
Registry conditions: Symptomatic Irreversible Pulpitis (SIP), Dental Pain, Inferior Alveolar Nerve Block Failure, Local Anesthesia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Is Intraligamentary Injection the Anesthesia of Choice for Symptomatic Irreversible Pulpitis in Mandibular Molars? A Multicenter Randomized Comparative Trial.

Overview

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

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.

Interventions

  • Procedure Intraligamentary Injection
    Intraligamentary local anesthesia will be administered using a standard dental syringe with 2% lidocaine and 1:100,000 epinephrine.
  • Procedure Inferior Alveolar Nerve Block
    Inferior alveolar nerve block will be performed with 2% lidocaine and 1:100,000 epinephrine using the conventional technique.

Primary outcome measures

  • Pain during endodontic access [Time frame: Immediately after access cavity preparation (within 30 minutes of anesthesia)]
Secondary outcome measures (4)
  • Need for supplementary anesthesia [Time frame: During access or initial root canal instrumentation (within first 45 minutes)]
  • Patient satisfaction immediately after treatment [Time frame: End of visit (within 1 hour)]
  • Postoperative pain at 7 days [Time frame: Day 7 post-treatment]
  • Patient satisfaction at 7 days [Time frame: Day 7 post-treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 2 centers
  • Clínica Dental 4 — Ferrol
  • Clínica Dental Esteve — Alicante

Identifiers

NCT: NCT07130760 · ILA VS AINB PULP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗