Is Intraligamentary Injection the Anesthesia of Choice for Symptomatic Irreversible Pulpitis in Mandibular Molars? A Multicenter Randomized Comparative Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Pain during endodontic access
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants will be unaware of which anesthetic technique is administered. Operators cannot be blinded due to the nature of the procedures.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Intraligamentary Injection Group
Patients in this arm will receive intraligamentary anesthesia prior to endodontic access.
Intervention: Intraligamentary Injection (Procedure)
Inferior Alveolar Nerve Block Group
Patients in this arm will receive standard inferior alveolar nerve block prior to endodontic access.
Intervention: Inferior Alveolar Nerve Block (Procedure)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Guillem Esteve-Pardo
Principal Investigator - DDS, PhD (Bioengineering)
Aula Dental Avanzada