Anesthetic EfficacyIANB SIP EPTNCT07409896
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
A study testing INTERVENTION 1: 2% Lignocaine 1:80,000 epinephrine and INTERVENTION 2 : 4%Articaine 1:100,000 epinephrine in people with Anesthetic Efficacy, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare the anesthetic efficacy of 2% lignocaine administered through an inferior alveolar nerve block (IANB) in one group of participants with 4% articaine delivered via primary buccal infiltration in other group in patients with symptomatic irreversible pulpitis in mandibular… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anesthetic Efficacy
- What is being tested?
- INTERVENTION 1: 2% Lignocaine 1:80,000 epinephrine and INTERVENTION 2 : 4%Articaine 1:100,000 epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2026to 20 Dec 2026
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy patients classified as ASA I, aged 18-55 years.
- Permanent mandibular first molar tooth requiring endodontic therapy.
- Diagnosed with symptomatic irreversible pulpitis without swelling or sinus.
- Normal periapical radiographic appearance (no evidence of periapical pathology).
- Moderate pain as assessed by the Heft-Parker VAS (>54 mm and <114 mm).
- Lingering pain or prolonged response to cold testing (lasting more than 10 seconds).
- Positive response to electric pulp testing.
- Outcome assessed must be pulpal anesthesia
Who cannot join
- • Pregnant or lactating mothers.
- Teeth with reversible pulpitis, previously treated, or with calcified canals.
- Teeth with severe periodontal disease or periapical radiolucency.
- Patients who have taken analgesics or anti-inflammatory drugs within 6 hours before the treatment visit.
- Patients on medications that could potentially interact with the anesthetic solution (e.g., antihypertensives, anticoagulants).
- History of allergy to 4% articaine, lidocaine, or epinephrine.
- Systemic diseases, immunocompromised states, or significant anxiety/mental health disorders.
- History of vasovagal syncope on local anesthetic administration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Armed Forces Institute of Dentistry AFID CMH Rawalpindi
Rawalpindi, Punjab Province, 46000
Sadia Shehzadi, BDS, FCPS Resident PGY3, 03342073051, sadiashehzadi321@gmail.com
About this study
This randomized controlled trial aims to compare the anesthetic efficacy of 2% lignocaine administered through an inferior alveolar nerve block (IANB) in one group of participants with 4% articaine delivered via primary buccal infiltration in other group in patients with symptomatic irreversible pulpitis in mandibular first molars.
Read the detailed description
This single-blinded randomized controlled trial evaluates the comparative anesthetic efficacy of two routinely used local anesthetic techniques for mandibular first molars diagnosed with symptomatic irreversible pulpitis. Inferior alveolar nerve block (IANB) using 2% lidocaine is a standard but technique-sensitive approach with reported failure rates of 20-25%, often influenced by anatomical variations and pulpal inflammation. Primary buccal infiltration with 4% articaine has emerged as a promising alternative due to superior bone penetration and favorable clinical outcomes in several studies, though evidence in adult South Asian populations remains limited.
A total of 330 systemically healthy adults (ASA I, aged 18-55 years) meeting strict diagnostic criteria for symptomatic irreversible pulpitis will be enrolled. Participants will be randomized into two groups:
- Group 1: 2% lidocaine (1:80,000 epinephrine) via IANB
- Group 2: 4% articaine (1:100,000 epinephrine) via primary buccal infiltration
All injections will be standardized to 1.8 mL delivered over 60 seconds using 27-gauge needles by a single experienced clinician. Topical anesthesia with benzocaine 20% will be used prior to injection. Dental anxiety will be screened using Corah's DAS, and patients with high or phobic anxiety scores will be excluded.
Fifteen minutes after administration, soft-tissue anesthesia will be confirmed (lip numbness for IANB and buccal probe response for infiltration). Pulpal anesthesia will be objectively assessed using an electric pulp tester (EPT) and subjectively using the Heft-Parker Visual Analogue Scale (VAS) at multiple treatment stages: baseline, post-injection, access preparation, pulp chamber entry, and root canal instrumentation.
Anesthetic success will be defined as:
- Two consecutive non-responsive EPT readings (max output 80)
- Mild or no pain during the procedure (VAS <55 mm)
Failure will be recorded if moderate/severe pain (VAS ≥55 mm) occurs at any stage or supplemental anesthesia is required.
The study aims to determine whether 4% articaine buccal infiltration can provide anesthetic efficacy equal to or superior to 2% lidocaine IANB for endodontic treatment of symptomatic mandibular first molars. The findings may help refine local anesthetic protocols and reduce the need for supplemental injections in challenging pulpal conditions.
- Conditions
- Anesthetic Efficacy
- Being tested
- INTERVENTION 1: 2% Lignocaine 1:80,000 epinephrine, INTERVENTION 2 : 4%Articaine 1:100,000 epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTERVENTION 1: 2% Lignocaine 1:80,000 epinephrineOther
2% Lignocaine Inferior Alveolar Nerve Block (IANB) : Participants in this group will receive an inferior alveolar nerve block using 2% Lignocaine with 1:80,000 epinephrine. The injection will be administered following standard IANB technique for mandibular first molars. The anesthetic efficacy will be assessed with 2 consecutive non responsive readings on EPT objectivelt and via Heft-Parker VAS not more than ≥55 .
INTERVENTION 2 : 4%Articaine 1:100,000 epinephrineOther
Participants in this group will receive a buccal infiltration of 4% Articaine with 1:100,000 epinephrine at the site of the mandibular first molar. The injection will follow standard buccal infiltration technique. Anesthetic efficacy will be evaluated during endodontic treatment using the same pain assessment method as Arm 1.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 : 2%Lignocaine 1:80,000 epinephrine | Active comparator | : 2% Lignocaine Inferior Alveolar Nerve Block (IANB) Participants in this group will receive an inferior alveolar nerve block using 2% Lignocaine with 1:80,000 epinephrine. Receives: Other: INTERVENTION 1: 2% Lignocaine 1:80,000 epinephrine |
| ARM 2 : 4% Articaine with 1:100,000 epinephrine | Active comparator | Participants in this group will receive 4% Articaine with 1:100,000 epinephrine at the site of the mandibular first molar. Receives: Other: INTERVENTION 2 : 4%Articaine 1:100,000 epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic efficacy
Description: Patients will be assigned to one of the two groups . Group 1: 2%Lignocaine 1;80,000 epinephrine 1.8 ml IANB Group 2: 4%Articaine 1:100,000 epinephrine 1.8 ml Primary buccal infilteration Efficacy will be considered if there are 2 consecutive non-responsive readings during 60 mins duration , usually measured on EPT 15 mins after administration of anesthesia . Any pain felt during the procedure will be measured according to Heft-Parker VAS and moderate-severe pain reported (VAS ≥ 55) will be regarded unsuccessful .
Time Frame: 1 hour after administration of local anesthetic agent .
Measured: 1 hour after administration of anesthetic agent
Secondary outcomes (1)
Duration of anesthesia
Description: Duration up to which Lignocaine IANB/Articaine Primary Buccal Infilteration remains successful after administration .
Time Frame: 1 hour 30 mins
Measured: 1 hour 30 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start20 Mar 2026
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthetic EfficacyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadia Shehzadi, Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409896
- Sponsor's protocol ID
- SS-ENDO-IANBART-2025
- Acronym
- IANB SIP EPT
- Status last verified
- Oct 2026
- First submitted
- 7 Dec 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because the study does not include plans or infrastructure for secure long term data storage, de-identification, and controlled access needed to protect participants privacy .Additionally, the data sheet is small and disclosure may include the risk of re-identification, summary results will be made available as required.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07409896
- Acronym / sponsor ID
- IANB SIP EPT / SS-ENDO-IANBART-2025
- Conditions
- Anesthetic Efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 13 Feb 2026 (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 randomized controlled trial aims to compare the anesthetic efficacy of 2% lignocaine administered through an inferior alveolar nerve block (IANB) in one group of participants with 4% articaine delivered via primary buccal infiltration in other group in patients with symptomatic irreversible pulpitis in mandibular first molars.
Detailed description
This single-blinded randomized controlled trial evaluates the comparative anesthetic efficacy of two routinely used local anesthetic techniques for mandibular first molars diagnosed with symptomatic irreversible pulpitis. Inferior alveolar nerve block (IANB) using 2% lidocaine is a standard but technique-sensitive approach with reported failure rates of 20-25%, often influenced by anatomical variations and pulpal inflammation. Primary buccal infiltration with 4% articaine has emerged as a promising alternative due to superior bone penetration and favorable clinical outcomes in several studies, though evidence in adult South Asian populations remains limited.
A total of 330 systemically healthy adults (ASA I, aged 18-55 years) meeting strict diagnostic criteria for symptomatic irreversible pulpitis will be enrolled. Participants will be randomized into two groups:
- Group 1: 2% lidocaine (1:80,000 epinephrine) via IANB
- Group 2: 4% articaine (1:100,000 epinephrine) via primary buccal infiltration
All injections will be standardized to 1.8 mL delivered over 60 seconds using 27-gauge needles by a single experienced clinician. Topical anesthesia with benzocaine 20% will be used prior to injection. Dental anxiety will be screened using Corah's DAS, and patients with high or phobic anxiety scores will be excluded.
Fifteen minutes after administration, soft-tissue anesthesia will be confirmed (lip numbness for IANB and buccal probe response for infiltration). Pulpal anesthesia will be objectively assessed using an electric pulp tester (EPT) and subjectively using the Heft-Parker Visual Analogue Scale (VAS) at multiple treatment stages: baseline, post-injection, access preparation, pulp chamber entry, and root canal instrumentation.
Anesthetic success will be defined as:
- Two consecutive non-responsive EPT readings (max output 80)
- Mild or no pain during the procedure (VAS <55 mm)
Failure will be recorded if moderate/severe pain (VAS ≥55 mm) occurs at any stage or supplemental anesthesia is required.
The study aims to determine whether 4% articaine buccal infiltration can provide anesthetic efficacy equal to or superior to 2% lidocaine IANB for endodontic treatment of symptomatic mandibular first molars. The findings may help refine local anesthetic protocols and reduce the need for supplemental injections in challenging pulpal conditions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 : 2%Lignocaine 1:80,000 epinephrine | Active comparator | Other: INTERVENTION 1: 2% Lignocaine 1:80,000 epinephrine: 2% Lignocaine Inferior Alveolar Nerve Block (IANB) Participants in this group will receive an inferior alveolar nerve block using 2% Lignocaine with 1:80,000 epinephrine. |
| ARM 2 : 4% Articaine with 1:100,000 epinephrine | Active comparator | Other: INTERVENTION 2 : 4%Articaine 1:100,000 epinephrineParticipants in this group will receive 4% Articaine with 1:100,000 epinephrine at the site of the mandibular first molar. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Systemically healthy patients classified as ASA I, aged 18-55 years.
- Permanent mandibular first molar tooth requiring endodontic therapy.
- Diagnosed with symptomatic irreversible pulpitis without swelling or sinus.
- Normal periapical radiographic appearance (no evidence of periapical pathology).
- Moderate pain as assessed by the Heft-Parker VAS (>54 mm and <114 mm).
Key exclusion criteria (8 listed)
- • Pregnant or lactating mothers.
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 |
|---|---|---|
| INTERVENTION 1: 2% Lignocaine 1:80,000 epinephrine2% Lignocaine Inferior Alveolar Nerve Block (IANB) : Participants in this group will receive an inferior alveolar nerve block using 2% Lignocaine with 1:80,000 epinephrine. The injection will be administered following standard IANB technique for mandibular first molars. The anesthetic efficacy will be assessed with 2 consecutive non responsive readings on EPT objectivelt and via Heft-Parker VAS not more than ≥55 . | Other | ARM 1 : 2%Lignocaine 1:80,000 epinephrine |
| INTERVENTION 2 : 4%Articaine 1:100,000 epinephrineParticipants in this group will receive a buccal infiltration of 4% Articaine with 1:100,000 epinephrine at the site of the mandibular first molar. The injection will follow standard buccal infiltration technique. Anesthetic efficacy will be evaluated during endodontic treatment using the same pain assessment method as Arm 1. | Other | ARM 2 : 4% Articaine with 1:100,000 epinephrine |
Primary outcome
Anesthetic efficacy
Time frame: 1 hour after administration of anesthetic agent
Description: Patients will be assigned to one of the two groups . Group 1: 2%Lignocaine 1;80,000 epinephrine 1.8 ml IANB Group 2: 4%Articaine 1:100,000 epinephrine 1.8 ml Primary buccal infilteration Efficacy will be considered if there are 2 consecutive non-responsive readings during 60 mins duration , usually measured on EPT 15 mins after administration of anesthesia . Any pain felt during the procedure will be measured according to Heft-Parker VAS and moderate-severe pain reported (VAS ≥ 55) will be regarded unsuccessful . Time Frame: 1 hour after administration of local anesthetic agent .
1 secondary outcome
Duration of anesthesia
Time frame: 1 hour 30 mins
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 27 Oct 2026.
- Comparison Of Anaesthetic Efficacy Of Articaine And Lidocaine In Nonsurgical Endodontic Treatment Of Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis. A Randomized Clinical TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared because the study does not include plans or infrastructure for secure long term data storage, de-identification, and controlled access needed to protect participants privacy .Additionally, the data sheet is small and disclosure may include the risk of re-identification, summary results will be made available as required.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTERVENTION 1: 2% Lignocaine 1:80,000 epinephrine and INTERVENTION 2 : 4%Articaine 1:100,000 epinephrine in people with Anesthetic Efficacy, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
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 8 inclusion and 8 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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 Dr. Sadia Shehzadi Dr. Sadia Shehzadi, BDS,FCPS(PG3) (03342073051, sadiashehzadi321@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthetic efficacy (time frame: 1 hour after administration of anesthetic agent). 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 27 Oct 2026.