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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAula Dental Avanzada

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intraligamentary Injection

    Procedure/Surgery

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

  • Inferior Alveolar Nerve Block

    Procedure/Surgery

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

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Intraligamentary Injection GroupExperimental treatment 1 intervention
Group B: Inferior Alveolar Nerve Block GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain during endodontic access

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

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

Secondary outcomes

1

Need for supplementary anesthesia

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

Time frame
During access or initial root canal instrumentation (within first 45 minutes)
2

Patient satisfaction immediately after treatment

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.

Time frame
End of visit (within 1 hour)
3

Postoperative pain at 7 days

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.

Time frame
Day 7 post-treatment
4

Patient satisfaction at 7 days

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.

Time frame
Day 7 post-treatment

Other outcomes

Sponsors and contacts

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