An interventional study of Intraligamentary Injection and Inferior Alveolar Nerve Block in Symptomatic Irreversible Pulpitis (SIP), Dental Pain and Inferior Alveolar Nerve Block Failure, sponsored by Aula Dental Avanzada. Recruiting at 2 sites in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Aula Dental Avanzada · Not applicable, Interventional, and Treatment
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.
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.
142 studies on the registry are indexed under Toothache; 28 are open to participants now.
This study's planned enrollment of 52 is below the median of 84 across 123 interventional studies indexed under Toothache.
Browse Toothache studies →Aula Dental Avanzada is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this arm will receive intraligamentary anesthesia prior to endodontic access.
Procedure: Intraligamentary Injection
Patients in this arm will receive standard inferior alveolar nerve block prior to endodontic access.
Procedure: Inferior Alveolar Nerve Block
Intraligamentary local anesthesia will be administered using a standard dental syringe with 2% lidocaine and 1:100,000 epinephrine.
Also known as: Intraligamental anesthesia (ILA), Periodontal ligament injection (PDL injection), Intraligamentary anesthetic technique
Inferior alveolar nerve block will be performed with 2% lidocaine and 1:100,000 epinephrine using the conventional technique.
Also known as: Inferior alveolar nerve anesthesia, Inferior dental block
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)
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)
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)
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
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
Plan to share: No — This study will not share individual participant data (IPD).
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jun 2027, 24 months after the start.
Of 44 non-industry interventional studies with no phase under Toothache, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 24 months is above that.
Counting every sponsor, half of 45 studies reached it within 5 months; a quarter within 3 and three quarters within 12.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Aula Dental Avanzada