Intraligamentary injection versus inferior alveolar nerve block for painful lower molar pulpitis
Is Intraligamentary Injection the Anesthesia of Choice for Symptomatic Irreversible Pulpitis in Mandibular Molars? A Multicenter Randomized Comparative Trial.
This trial will see if an intraligamentary injection or an inferior alveolar nerve block gives better pain control for adults having root canal treatment of a painful lower molar with symptomatic irreversible pulpitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aula Dental Avanzada Academic / other |
| Locations | 2 sites (Ferrol, A coruña and 1 other locations) |
| Trial ID | NCT07130760 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized, controlled trial comparing two local anesthesia techniques—an intraligamentary injection (ILA) and an inferior alveolar nerve block (IANB)—in adults with symptomatic irreversible pulpitis of mandibular molars. Eligible patients are randomized to receive one of the two techniques before endodontic access, with standardized protocols across participating dental clinics. Pain and anesthetic success are measured using validated pain scales during the procedure and analyzed statistically to compare outcomes. Patients with contraindications such as allergy to lidocaine/epinephrine, pregnancy, recent analgesic use, non-vital or previously treated teeth, or significant systemic disease are excluded.
Who should consider this trial
Good fit: Adults aged 18 or older with symptomatic irreversible pulpitis in a mandibular molar who give informed consent and have a vital response to cold testing are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, allergic to lidocaine/epinephrine, have non-vital or previously treated teeth, recent analgesic use, or significant systemic disease (ASA III or above) are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could identify a more reliable anesthesia technique that reduces intraoperative pain and the need for supplemental injections during root canal treatment of lower molar pulpitis.
How similar studies have performed: Previous research shows intraligamentary injections can be effective as supplemental anesthesia when IANB fails, but direct randomized head-to-head comparisons as primary techniques are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ferrol, A coruña and 1 other locations
- Clínica Dental 4 — Ferrol, A coruña, Spain (Recruiting)
- Clínica Dental Esteve — Alicante, Alicante, Spain (Recruiting)
Study contacts
- Study coordinator: Guillem Esteve-Pardo, PhD
- Email: guillem@clinicaesteve.com
- Phone: 34965215755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.