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NCT Number: NCT07130760

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

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.

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Key information

Conditions

Symptomatic Irreversible Pulpitis (SIP) Dental Pain Facial Pain Inferior Alveolar Nerve Block Failure Local Anesthesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Dental 4, Ferrol, A coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraligamentary Injection

Procedure

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

Other names: Intraligamental anesthesia (ILA), Periodontal ligament injection (PDL injection), Intraligamentary anesthetic technique

Inferior Alveolar Nerve Block

Procedure

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

Other names: Inferior alveolar nerve anesthesia, Inferior dental block

Primary outcomes

  1. Pain during endodontic access

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

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

Secondary outcomes

  1. Need for supplementary anesthesia

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

    Whether the initial anesthesia technique was sufficient or required additional anesthetic injection to complete the procedure pain-free.

  2. Patient satisfaction immediately after treatment

    Time frame: End of visit (within 1 hour)

    Patient-reported satisfaction immediately after treatment will be measured using a 5-point Likert scale. The scale ranges from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate better satisfaction.

  3. Postoperative pain at 7 days

    Time frame: Day 7 post-treatment

    Pain intensity reported by the patient at day 7 after treatment will be assessed using a 4-point ordinal scale: 1 (none), 2 (mild), 3 (moderate), 4 (severe). Higher scores indicate worse pain.

  4. Patient satisfaction at 7 days

    Time frame: Day 7 post-treatment

    Patient-reported satisfaction one week after treatment will be measured using a 5-point Likert scale. The scale ranges from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate better satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Guillem Esteve-Pardo, PhD

CONTACT

[email protected]

34965215755

Sponsors and collaborators

Lead sponsor

Aula Dental Avanzada

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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