Symptomatic Irreversible Pulpitis (SIP), Dental Pain, Inferior Alveolar Nerve Block Failure, Local Anesthesia
Conditions
Keywords
Inferior alveolar nerve block, Pulpitis Mandibular molars, Emergency dental treatment, Symptomatic irreversible pulpitis, Randomized clinical trial, Endodontics, Dental pain, Local anesthesia, Intraligamentary anesthesia
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.
Interventions
PROCEDUREIntraligamentary Injection
Intraligamentary local anesthesia will be administered using a standard dental syringe with 2% lidocaine and 1:100,000 epinephrine.
PROCEDUREInferior Alveolar Nerve Block
Inferior alveolar nerve block will be performed with 2% lidocaine and 1:100,000 epinephrine using the conventional technique.
Sponsors
Aula Dental Avanzada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be unaware of which anesthetic technique is administered. Operators cannot be blinded due to the nature of the procedures.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain during endodontic access | 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
| Measure | Time frame | Description |
|---|---|---|
| Need for supplementary anesthesia | During access or initial root canal instrumentation (within first 45 minutes) | Whether the initial anesthesia technique was sufficient or required additional anesthetic injection to complete the procedure pain-free. |
| Patient satisfaction immediately after treatment | End of visit (within 1 hour) | 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. |
| Postoperative pain at 7 days | Day 7 post-treatment | 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. |
| Patient satisfaction at 7 days | Day 7 post-treatment | 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. |
Countries
Spain
Contacts
Primary ContactGuillem Esteve-Pardo, PhD
Outcome results
None listed