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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraligamentary Injection Group | Experimental | Patients in this arm will receive intraligamentary anesthesia prior to endodontic access. |
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| Inferior Alveolar Nerve Block Group | Active Comparator | Patients in this arm will receive standard inferior alveolar nerve block prior to endodontic access. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraligamentary Injection | Procedure | Intraligamentary local anesthesia will be administered using a standard dental syringe with 2% lidocaine and 1:100,000 epinephrine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain during endodontic access | Pain intensity experienced by the patient during endodontic access after the assigned anesthetic technique. | Immediately after access cavity preparation (within 30 minutes of anesthesia) |
| Measure | Description | Time Frame |
|---|---|---|
| Need for supplementary anesthesia | Whether the initial anesthesia technique was sufficient or required additional anesthetic injection to complete the procedure pain-free. | During access or initial root canal instrumentation (within first 45 minutes) |
| Patient satisfaction immediately after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillem Esteve-Pardo, PhD | Contact | 34965215755 | guillem@clinicaesteve.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClĂnica Dental 4 | Recruiting | Ferrol | A coruña | 15402 | Spain |
This study will not share individual participant data (IPD).
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Participants will be randomly assigned to receive either intraligamentary injection or inferior alveolar nerve block prior to endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.
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Participants will be unaware of which anesthetic technique is administered. Operators cannot be blinded due to the nature of the procedures.
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| Inferior Alveolar Nerve Block | Procedure | Inferior alveolar nerve block will be performed with 2% lidocaine and 1:100,000 epinephrine using the conventional technique. |
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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. |
| 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. | 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. | Day 7 post-treatment |
| ClĂnica Dental Esteve | Recruiting | Alicante | Alicante | 03001 | Spain |
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| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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