Symptomatic Irreversible Pulpitis (SIP)NCT07130760
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
A study testing Intraligamentary Injection and Inferior Alveolar Nerve Block in people with Symptomatic Irreversible Pulpitis (SIP) and Dental Pain, run by Aula Dental Avanzada at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis (SIP), Dental Pain, Inferior Alveolar Nerve Block Failure
- What is being tested?
- Intraligamentary Injection and Inferior Alveolar Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesSpain
- Study dates
- 20 Jun 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Clínica Dental Esteve
Alicante, Alicante, 03001
Guillem Esteve-Pardo, PhD, 34965215755, guillem@clinicaesteve.com
Guillem Esteve-Pardo, PhD
- Recruiting
Clínica Dental 4
Ferrol, A coruña, 15402
Pedro Barreiro-Gabeiras, DDS, 34981358375, clinica4dental@gmail.com
About this study
Official title: Is Intraligamentary Injection the Anesthesia of Choice for Symptomatic Irreversible Pulpitis in Mandibular Molars? A Multicenter Randomized Comparative Trial.
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.
Read the 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.
- Conditions
- Symptomatic Irreversible Pulpitis (SIP), Dental Pain, Inferior Alveolar Nerve Block Failure, Local Anesthesia
- Being tested
- Intraligamentary Injection, Inferior Alveolar Nerve Block
- Keywords
- Inferior alveolar nerve block, Pulpitis Mandibular molars, Emergency dental treatment, Symptomatic irreversible pulpitis, Randomized clinical trial, Endodontics, Dental pain, Local anesthesia, Intraligamentary anesthesia
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraligamentary InjectionProcedure or surgery
Also called Intraligamental anesthesia (ILA), Periodontal ligament injection (PDL injection), Intraligamentary anesthetic technique
Intraligamentary local anesthesia will be administered using a standard dental syringe with 2% lidocaine and 1:100,000 epinephrine.
Inferior Alveolar Nerve BlockProcedure or surgery
Also called Inferior alveolar nerve anesthesia, Inferior dental block
Inferior alveolar nerve block will be performed with 2% lidocaine and 1:100,000 epinephrine using the conventional technique.
| Study group | Role | What they receive |
|---|---|---|
| Intraligamentary Injection Group | Experimental | Patients in this arm will receive intraligamentary anesthesia prior to endodontic access. Receives: Procedure: Intraligamentary Injection |
| Inferior Alveolar Nerve Block Group | Active comparator | Patients in this arm will receive standard inferior alveolar nerve block prior to endodontic access. Receives: Procedure: Inferior Alveolar Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during endodontic access
Pain intensity experienced by the patient during endodontic access after the assigned anesthetic technique.
Measured: Immediately after access cavity preparation (within 30 minutes of anesthesia)
Secondary outcomes (4)
Need for supplementary anesthesia
Whether the initial anesthesia technique was sufficient or required additional anesthetic injection to complete the procedure pain-free.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 7 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start20 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible Pulpitis (SIP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aula Dental Avanzada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillem Esteve-Pardo, Aula Dental Avanzada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130760
- Sponsor's protocol ID
- ILA VS AINB PULP
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will not share individual participant data (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Intraligamentary Injection the Anesthesia of Choice for Symptomatic Irreversible Pulpitis in Mandibular Molars? A Multicenter Randomized Comparative Trial.
- ClinicalTrials.gov ID
- NCT07130760
- Acronym / sponsor ID
- ILA VS AINB PULP
- Conditions
- Symptomatic Irreversible Pulpitis (SIP), Dental Pain, Inferior Alveolar Nerve Block Failure, Local Anesthesia
- Keywords
- Inferior alveolar nerve block, Pulpitis Mandibular molars, Emergency dental treatment, Symptomatic irreversible pulpitis, Randomized clinical trial, Endodontics, Dental pain, Local anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Aula Dental AvanzadaUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intraligamentary Injection Group | Experimental | Procedure: Intraligamentary InjectionPatients in this arm will receive intraligamentary anesthesia prior to endodontic access. |
| Inferior Alveolar Nerve Block Group | Active comparator | Procedure: Inferior Alveolar Nerve BlockPatients in this arm will receive standard inferior alveolar nerve block prior to endodontic access. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraligamentary InjectionAlso: Intraligamental anesthesia (ILA), Periodontal ligament injection (PDL injection), Intraligamentary anesthetic techniqueIntraligamentary local anesthesia will be administered using a standard dental syringe with 2% lidocaine and 1:100,000 epinephrine. | Procedure or surgery | Intraligamentary Injection Group |
| Inferior Alveolar Nerve BlockAlso: Inferior alveolar nerve anesthesia, Inferior dental blockInferior alveolar nerve block will be performed with 2% lidocaine and 1:100,000 epinephrine using the conventional technique. | Procedure or surgery | Inferior Alveolar Nerve Block Group |
Primary outcome
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.
4 secondary outcomes
Need for supplementary anesthesia
Time frame: During access or initial root canal instrumentation (within first 45 minutes)
Patient satisfaction immediately after treatment
Time frame: End of visit (within 1 hour)
Postoperative pain at 7 days
Time frame: Day 7 post-treatment
Patient satisfaction at 7 days
Time frame: Day 7 post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No. This study will not share individual participant data (IPD).
Related trials for Symptomatic Irreversible Pulpitis (SIP)
Recruiting
Comparison of Anesthetic Efficacy OF 2% Lidocaine Inferior Alveolar Nerve (IANB) Block Versus Primary Buccal Infilteration With 4% Articaine in Symptomatic Irreversible Pulpitis(SIP) IN Mandibular First Molars
Anesthetic Efficacy
Not yet recruiting
Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis
Recruiting
Short Term Comparative Assessment of MTA and Biodentine in Complete Pulpotomy for Symptomatic Irreversible Pulpitis
Symptomatic Irreversible Pulpitis (SIP)
Recruiting
Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite
Symptomatic Irreversible Pulpitis (SIP), Extremely Deep Caries
RecruitingEarly Phase 1
Comparison Of Acetaminophen, NSAIDs, And Trypsin-Chymotrypsin Plus Acetaminophen For Post-Endodontic Pain After Single-Visit Root Canal Treatment
Symptomatic Irreversible Pulpitis (SIP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraligamentary Injection and Inferior Alveolar Nerve Block in people with Symptomatic Irreversible Pulpitis (SIP) and Dental Pain, run by Aula Dental Avanzada at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillem Esteve-Pardo, PhD (34965215755, guillem@clinicaesteve.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during endodontic access (time frame: Immediately after access cavity preparation (within 30 minutes of anesthesia)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.