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PainNCT07905196

Anesthetic Effectiveness of Mental/Incisive Nerve Block Versus Inferior Nerve Block Using 4% Articaine and 2% Lidocaine in Mandibular First and Second Premolars With Symptomatic Irreversible Pulpitis.

A study testing Group A : MINB with 2% Lidocaine HCL+ 1:1000,000 Epinephrine - 1.8 ml, Group B : MINB with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 ml and Group C : IANB with 2% Lidocaine HCL + 1:1000,000 Epinephrine - 1.8 ml in people with Pain, run by Foundation University Islamabad at 1 site in Pakistan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to check the anesthetic effectiveness of 4% Articaine and 2% Lidocaine in IANB Vs Mental nerve block in 1st and 2nd premolars with symptomatic Irreversible Pulpitis. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Pain
What is being tested?
Group A : MINB with 2% Lidocaine HCL+ 1:1000,000 Epinephrine - 1.8 ml, Group B : MINB with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 ml and Group C : IANB with 2% Lidocaine HCL + 1:1000,000 Epinephrine - 1.8 ml
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 sitePakistan
Study dates
1 Oct 2026to 1 Mar 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 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 18 to 55 years.
  • Mandibular first and second premolars presenting with symptomatic irreversible pulpitis.
  • Positive cold test.

Who cannot join

  • Allergy or contraindication to any component of local anesthesia.
  • History of confirmed or suspected substance abuse.
  • Radiographic evidence of periapical pathology.
  • Advanced periodontal disease.
  • Lack of soft tissue numbness 15 mins after assigned anesthetic technique.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gul Andama Ihsan, FCPS Resident contact

03331629743

gulihsan949@gmail.com

Pakistan1 site
  • Foundation University Islamabad

    Islamabad, Federal, 44000

    Clinical FUCD, clinicaltrials.fucd@fui.edu.pk

Other trials in Pakistan

About this study

Official title: Anesthetic Effectiveness of Mental/Incisive Nerve Block Versus Inferior Nerve Block Using 4% Articaine and 2% Lidocaine in Mandibular First and Second Premolars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

The purpose of this study is to check the anesthetic effectiveness of 4% Articaine and 2% Lidocaine in IANB Vs Mental nerve block in 1st and 2nd premolars with symptomatic Irreversible Pulpitis. This study aims to compare and find the best possible anesthetic solution amongst 2% Lidocaine and 4% Articaine and technique ie IANB Vs Mental Nerve block to make endodontic procedure pain free or comfortable for the patient

Read the detailed description

This study will be including four treatment groups. Conducted as a single blind Randomized control Trial i.e. 2x2 Factorial Design. Primary purpose will be to evaluate the main effect of injection technique , main effect of anesthetic solution and potential interaction between 2 solutions.

This study will be conducted in Department of Operative Dentistry and Endodontics, Foundation University College of dentistry and Hospital , following approval from Institutional Ethical Review committee A total of 108 participants will be recruited. The calculation was based on previously reported anesthetic success rates for MINB and IANB using 2% Lidocaine and 4% Articaine Participants reporting to operative Dentistry department with Symptomatic Irreversible pulpitis in mandibular first and second premolars. Participants meeting inclusion criteria will be invited.

PRE OPERATIVE CLINICAL ASSESMENT will be done i.e. Age , Gender , relevant medical history , Current medications , History of allergies to LA or related components, Any previous anesthesia related events , Intensity of pain before treatment , Presence duration and characteristics of pain. Any condition that may contraindicate the administration of anesthesia Diagnosis of Symptomatic Irreversible pulpitis will be done using a combination of patients history , clinical examination , cold testing and Radiographic evaluation , Pre operative pain assessment using NRS Numerical rating scale from O-10 ADMINSTRATION OF LOCAL ANESTHESIA For MINB groups, 1.8ml of the assigned anesthetic will be deposited in the region of mental foramen after negative aspiration For IANB groups, 1.8ml of the assigned anesthetic will be administered using conventional inferior alveolar nerve block technique after negative aspiration A standardized 15 mins waiting period will be observed after injection. Soft tissue assessment will be done by subjective numbness/probing of buccal gingiva.

PAIN ASSESMENT pain will be recorded using NRS during

  1. Access cavity preparation
  2. Pulp extirpation The outcome accessor will remain blinded DEFINITION OF ANESTHETIC SUCCESS Success : NRS 0-3 During treatment without the need for supplemental anesthesia Failure : NRS >3 requiring supplemental anesthesia DATA COLLECTION Following will be recorded Age and gender , tooth type , Pre operative and cold test pain scores , Injection technique , Anesthetic Solution, Soft tissue numbness , intraoperative pain , Any need for supplemental anesthesia , Injection related complications.

PRIMARY OUTCOME

The analysis will evaluate:

  1. Main effect of injection technique
  2. Main effect of anesthetic solution
  3. Interaction between injection technique and anesthetic solution SAFETY any complications including injection site discomfort , hematoma , persistent numbness or other adverse events will be documented and managed according to standard protocols
Conditions
Pain
Being tested
Group A : MINB with 2% Lidocaine HCL+ 1:1000,000 Epinephrine - 1.8 ml, Group B : MINB with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 ml, Group C : IANB with 2% Lidocaine HCL + 1:1000,000 Epinephrine - 1.8 ml, Group D : IANB with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 ml
Keywords
Pain
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A : MINB with 2% Lidocaine HCL+ 1:1000,000 Epinephrine - 1.8 mlProcedure or surgery

    Group A will be administered with 2% Lidocaine HCL + 1:1000,000 Epinephrine - 1.8 ml through Mental/Incisive nerve block technique

  • Group B : MINB with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 mlProcedure or surgery

    Group B will be administered with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 ml through Mental/Incisive nerve block technique

  • Group C : IANB with 2% Lidocaine HCL + 1:1000,000 Epinephrine - 1.8 mlProcedure or surgery

    Group C will be administered with 2% Lidocaine HCL + 1:1000,000 Epinephrine - 1.8 ml through Inferior Alveolar nerve block technique

  • Group D : IANB with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 mlProcedure or surgery

    Group D will be administered with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 ml through inferior alveolar nerve block

Study groups in NCT07905196
Study groupRoleWhat they receive
Group A: MINB + 2% LidocaineExperimentalGroup A will be administered 2% Lidocaine (1: 100,000 epi) using Mental nerve block technique
Receives: Procedure: Group A : MINB with 2% Lidocaine HCL+ 1:1000,000 Epinephrine - 1.8 ml
Group A: MINB + 4% ArticaineExperimentalGroup B will be administered 4% Articaine (1: 100,000 epi) using Mental nerve block technique
Receives: Procedure: Group B : MINB with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 ml
Group C : IANB + 2% LidocaineExperimentalGroup C will be administered 2% lidocaine (1: 100,000 epi) using Inferior Alveolar nerve block technique
Receives: Procedure: Group C : IANB with 2% Lidocaine HCL + 1:1000,000 Epinephrine - 1.8 ml
Group D : IANB + 4% ArticaineExperimentalGroup D will be administered 4% Articaine (1: 100,000 epi) using Inferior Alveolar nerve block technique
Receives: Procedure: Group D : IANB with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 ml

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anesthetic Success Rate

    Anesthetic success rate defined as completing access cavity preparation + pulp extirpation with

    1. Success : NRS 0-3 ( No pain/ Mild pain) WITHOUT need for supplemental anesthesia
    2. Failure : NRS>3 ( Moderate/Severe pain) requiring supplemental anesthesia

    Measured: Periprocedural and Intraprocedural 1) Preprocedural Assessment of pain on NRS scale (0-10) 2)Intra- Procedural Outcome is Assessed at 15 minutes after giving anesthesia. If no numbness after 15 minutes the patient is excluded from the study.

Secondary outcomes (4)
  1. Pain scores (NRS 0-10) at 4 time points

    Pain scores recorded at 4 time points

    1. Preoperative pain
    2. Pain response to Cold test
    3. Pain during access cavity preparation
    4. Pain during pulp extirpation

    Measured: Intraoperative

  2. Soft tissue anesthesia success

    Presence of soft tissue numbness at 15 mins post-injection assessed by tactile sensation + gentle probing of buccal gingiva

    Measured: Intraoperative

  3. Need for Supplemental Anesthesia

    Yes/No and Type : Intra ligamental/Additional block/Buccal Infiltration /Intra pulpal

    Measured: Intraoperative

  4. Complications

    Complications after anesthesia can occur like Persistent numbness/Hematoma /Discomfort at injection site /

    Measured: Intraoperative/ Postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

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
Factorial
Model description
Single blind Randomized control trial 2x2 factorial design. A total of 108 participants with symptomatic irreversible pulpitis will be randomly allocated into 4 groups according to injection technique (i.e. Inferior Alveolar nerve block vs Mental Nerve block) and injection solution (i.e. 2% Lidocaine vs 4% Articaine). The anesthetic effectiveness will be assessed during cavity preparation and pulp extirpation using Numerical Rating scale NRS from 0 to 10
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07905196
Sponsor's protocol ID
FUCD-OPERATIVE-2601
Status last verified
Oct 2026
First submitted
23 Sep 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ghabraei S, Shubbar A, Nekoofar MH, Nosrat A. Anesthetic efficacy of mental/incisive nerve block compared to inferior alveolar nerve block using 4% articaine in mandibular premolars with symptomatic irreversible pulpitis: a randomized clinical trial. Clin Oral Investig. 2019 Feb;23(2):839-845. doi: 10.1007/s00784-018-2500-4. Epub 2018 Jun 7.

    PubMed 29882110
  • Aggarwal V, Singla M, Miglani S, Kohli S. Comparative Evaluation of Mental Incisal Nerve Block, Inferior Alveolar Nerve Block, and Their Combination on the Anesthetic Success Rate in Symptomatic Mandibular Premolars: A Randomized Double-blind Clinical Trial. J Endod. 2016 Jun;42(6):843-5. doi: 10.1016/j.joen.2016.02.015. Epub 2016 Apr 14.

    PubMed 27086046
  • Lozano Gonzalez O, Salas Orozco MF, Trigueros Mancera J, Martinez Cuellar NG, Luna Dominguez C, Rosales Garcia P. Anesthetic Efficacy of Mental/Incisive Nerve Block Versus Inferior Alveolar Nerve Block in Mandibular Premolars With Symptomatic Irreversible Pulpitis: A Systematic Review and Meta-Analysis. Cureus. 2025 Nov 10;17(11):e96492. doi: 10.7759/cureus.96492. eCollection 2025 Nov.

    PubMed 41384210
  • Saha SG, Jain S, Dubey S, Kala S, Misuriya A, Kataria D. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. J Clin Diagn Res. 2016 Feb;10(2):ZC25-9. doi: 10.7860/JCDR/2016/16873.7195. Epub 2016 Feb 1.

    PubMed 27042580
  • Sulek T, Dumani A, Kuden C, Kussever H, Yoldas O. Anesthetic Effectiveness of Mental/Incisive Nerve Block versus Inferior Alveolar Nerve Block in Mandibular First and Second Premolars with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2025 Apr;51(4):473-480. doi: 10.1016/j.joen.2025.01.016. Epub 2025 Jan 27.

    PubMed 39880189
  • Karapinar-Kazandag M, Tanalp J, Ersev H. Effect of Premedication on the Success of Inferior Alveolar Nerve Block in Patients with Irreversible Pulpitis: A Systematic Review of the Literature. Biomed Res Int. 2019 Feb 10;2019:6587429. doi: 10.1155/2019/6587429. eCollection 2019.

    PubMed 30881994

Questions about this trial

What is this clinical trial studying?

A study testing Group A : MINB with 2% Lidocaine HCL+ 1:1000,000 Epinephrine - 1.8 ml, Group B : MINB with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 ml and Group C : IANB with 2% Lidocaine HCL + 1:1000,000 Epinephrine - 1.8 ml in people with Pain, run by Foundation University Islamabad 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 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 Gul Andama Ihsan, FCPS Resident (03331629743, gulihsan949@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anesthetic Success Rate (time frame: Periprocedural and Intraprocedural 1) Preprocedural Assessment of pain on NRS scale (0-10) 2)Intra- Procedural Outcome is Assessed at 15 minutes after giving anesthesia. If no numbness after 15 minutes the patient is excluded from the study.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07905196, which also lists 6 linked publications.

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 29 Oct 2026.

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