Irreversible PulpitisPhase 4ARTLID-IPNCT07869394
Articaine Versus Lidocaine for Supplemental Buccal Infiltration in Lower First Molars With Irreversible Pulpitis
A Phase 4 study testing Articaine 4% with epinephrine 1:100,000 and Lidocaine 2% with Epinephrine 1:100,000 in people with Irreversible Pulpitis and Failed Inferior Alveolar Nerve Block, run by Rehman Medical Institute - RMI at 1 site in Pakistan.
Trial summary
Local anesthetic is used to numb a tooth before a root canal treatment. In lower back teeth with irreversible pulpitis (a painful, inflamed tooth nerve), the standard numbing injection near the jaw nerve, called an inferior alveolar nerve block, often does not numb the tooth enough. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Irreversible Pulpitis, Failed Inferior Alveolar Nerve Block
- What is being tested?
- Articaine 4% with epinephrine 1:100,000 and Lidocaine 2% with Epinephrine 1:100,000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Mar 2026to 27 Aug 2026
- Phase
- Phase 4
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 to 50 years
- Systemically healthy (ASA I or II)
- Mandibular first molar with symptomatic irreversible pulpitis, diagnosed by a history of spontaneous pain, prolonged response to cold testing (EndoFrost), and bleeding pulpal tissue on access cavity preparation
- Radiographic absence of periapical radiolucency, apart from widening of the periodontal ligament
- Able to provide written informed consent
Who cannot join
- Pregnancy or lactation
- History of allergy to amide-type local anesthetics
- Acute apical abscess
- Necrotic pulp
- Periodontal pathology
- Retreatment cases
- Use of analgesics or anti-inflammatory drugs, or other medications that could alter pain perception, within 12 hours before treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Articaine Versus Lidocaine in Supplemental Infiltration for Mandibular First Molars With Symptomatic Irreversible Pulpitis After Failed Inferior Alveolar Nerve Block: A Prospective Randomized Double-Blind Clinical Trial
Local anesthetic is used to numb a tooth before a root canal treatment. In lower back teeth with irreversible pulpitis (a painful, inflamed tooth nerve), the standard numbing injection near the jaw nerve, called an inferior alveolar nerve block, often does not numb the tooth enough. When this happens, patients may feel pain during treatment, and dentists often give an extra injection beside the tooth.
This study compares two numbing medicines used for that extra injection: 4% articaine and 2% lidocaine, both with epinephrine. Articaine is a newer medicine that may pass through bone more easily, but it is not clear whether it works better than lidocaine in this situation.
Adults aged 18 to 50 with a painful lower first molar needing a root canal first receive the standard nerve block with lidocaine. Patients who still feel pain when the dentist begins opening the tooth then receive an extra injection beside the tooth, with either articaine or lidocaine. Which medicine is given is decided by chance, and neither the patient nor the dentist knows which one it is.
Read the detailed description
Background: Inferior alveolar nerve block (IANB) with lidocaine is the standard anesthetic technique for mandibular molars, but it frequently fails in teeth with symptomatic irreversible pulpitis because of inflammation, altered nerve excitability and anatomical variation. Supplemental buccal infiltration is commonly used after a failed block. Articaine has higher lipid solubility than lidocaine and may diffuse better through mandibular cortical bone, but evidence for its superiority as a supplemental infiltration is inconclusive.
Design: This is a prospective, randomized, double-blind, two-arm parallel clinical trial conducted in the Department of Endodontics. Patients are randomized using a computer-generated list, with allocation concealed in sequentially numbered, opaque, sealed envelopes opened by an independent assistant who takes no part in treatment or evaluation. The anesthetic cartridges are masked and coded by a second investigator who is not involved in the clinical procedures, so the operator and patient are blinded to the drug used.
Procedures: All participants receive an IANB with 1.8 mL of 2% lidocaine with 1:100,000 epinephrine. After 10 minutes, anesthesia is assessed with an electric pulp tester and a cold stimulus. Patients who report pain during access cavity preparation despite lip and tongue numbness are considered to have a failed IANB. They receive a buccal infiltration next to the mandibular first molar with 1.8 mL of either 4% articaine or 2% lidocaine, each with 1:100,000 epinephrine. Injections use a standard aspirating dental syringe with a 27-gauge long needle for the IANB and a 30-gauge short needle for the infiltration. Pain during the procedure is recorded with the Heft-Parker Visual Analog Scale. If a patient reports moderate or severe pain, intraligamentary or intrapulpal anesthesia is given and the case is recorded as a failure for the assigned drug.
Sample size: Assuming a 30% difference in success rates, 80% power and a 5% significance level, at least 25 patients per group were required. To allow for dropouts, 30 patients per group were planned.
Analysis: Data are analyzed in SPSS version 21. Success rates are compared with the chi-square or Fisher's exact test, and VAS scores with the Mann-Whitney U test. A p-value below 0.05 is considered significant.
Ethics: The protocol was approved by the Institutional Ethics Committee and follows the Declaration of Helsinki. Written informed consent is obtained from all participants.
- Being tested
- Articaine 4% with epinephrine 1:100,000, Lidocaine 2% with Epinephrine 1:100,000
- Keywords
- Articaine, Lidocaine, Supplemental Infiltration, Buccal Infiltration, Inferior Alveolar Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articaine 4% with epinephrine 1:100,000Drug
Also called Articaine Hydrochloride, Articaine with Adrenaline
Supplemental buccal infiltration of 1.8 mL of 4% articaine with 1:100,000 epinephrine, given next to the mandibular first molar with a standard aspirating dental syringe and a 30-gauge short needle. It is given only to participants who report pain during access cavity preparation after an inferior alveolar nerve block with 2% lidocaine.
Lidocaine 2% with Epinephrine 1:100,000Drug
Also called Lidocaine Hydrochloride, Lignocaine with Adrenaline
Supplemental buccal infiltration of 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, given next to the mandibular first molar with a standard aspirating dental syringe and a 30-gauge short needle. It is given only to participants who report pain during access cavity preparation after an inferior alveolar nerve block with 2% lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| Articaine Supplemental Buccal Infiltration | Experimental | All participants first receive an inferior alveolar nerve block with 1.8 mL of 2% lidocaine with 1:100,000 epinephrine. Participants who report pain during access cavity preparation (failed block) receive a supplemental buccal infiltration next to the mandibular first molar with 1.8 mL of 4% articaine with 1:100,000 epinephrine, using a 30-gauge short needle. Anesthetic success is judged by whether access preparation and initial instrumentation can be completed without pain. Receives: Drug: Articaine 4% with epinephrine 1:100,000 |
| Lidocaine Supplemental Buccal Infiltration | Active comparator | All participants first receive an inferior alveolar nerve block with 1.8 mL of 2% lidocaine with 1:100,000 epinephrine. Participants who report pain during access cavity preparation (failed block) receive a supplemental buccal infiltration next to the mandibular first molar with 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, using a 30-gauge short needle. Anesthetic success is judged by whether access preparation and initial instrumentation can be completed without pain. Receives: Drug: Lidocaine 2% with Epinephrine 1:100,000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Pulpal Anesthesia With Supplemental Buccal Infiltration
Proportion of participants in whom access cavity preparation and initial instrumentation were completed without pain after supplemental buccal infiltration. Success was defined as no reported pain and no need for additional anesthesia. Pain was assessed using the Heft-Parker Visual Analog Scale (0-170 mm), with higher scores indicating greater pain intensity.
Measured: Immediately after initial instrumentation during the single treatment visit.
Secondary outcomes (1)
Pain Intensity During Access Cavity Preparation (Heft-Parker VAS)
Pain intensity reported by participants using the Heft-Parker Visual Analog Scale (HP-VAS) during access cavity preparation and initial instrumentation after supplemental infiltration, compared between the articaine and lidocaine groups. The HP-VAS ranges from 0 to 170 mm, with higher scores indicating greater pain intensity (worse outcome).
Measured: Immediately after completion of access cavity preparation and initial instrumentation during the single treatment visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start3 Mar 2026
- Primary completion7 Aug 2026
- Study completion27 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel trial. All participants first receive an inferior alveolar nerve block with 2% lidocaine. Those who experience pain during access preparation are randomized to a supplemental buccal infiltration with either 4% articaine or 2% lidocaine, each with 1:100,000 epinephrine.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehman Medical Institute - RMI
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muzdalfa hanif, Rehman Medical Institute - RMI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869394
- Sponsor's protocol ID
- ARTLID-SUPP-IANB-001
- Acronym
- ARTLID-IP
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No