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CompletedNCT04822415Updated Aug 2, 2021

Anaesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine With Symptomatic Irreversible Pulpitis

An interventional study of Mepivacaine and Articaine in Symptomatic Irreversible Pulpitis, sponsored by Cairo University. Completed. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-08-02.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 6 years 3 months after the study started (first participant enrolled Dec 2014, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
330
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
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Study summary

The aim of this randomized, double-blinded, clinical trial was to assess the effect of 3.6 mL 2% mepivacaine hydrochloride with 1:100,000 epinephrine compared to 3.4 mL 4% articaine hydrochloride with 1:100,000 epinephrine on the success of the inferior alveolar nerve block for patients with symptomatic irreversible pulpitis in mandibular molars.

Read the detailed description

The aim of this randomized, double-blinded, clinical trial was to assess the effect of 3.6 mL 2% mepivacaine hydrochloride with 1:100,000 epinephrine compared to 3.4 mL 4% articaine hydrochloride with 1:100,000 epinephrine on the success of the inferior alveolar nerve block for patients with symptomatic irreversible pulpitis in mandibular molars. Patients were clinically and radiographically examined and their eligibility assessed and preoperative pain was measured using the numerical rating scale (NRS). Patients were randomly assigned to one of 2 groups: experimental group (2% mepivacaine) and the control group (4% articaine). After 15 minutes of the inferior alveolar nerve block (IANB), patients reporting lip numbness had their molars accessed. No-to-mild pain response was considered success during root canal preparation.

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Conditions studied

  • Symptomatic Irreversible Pulpitis

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In context

Pulpitis

302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.

This study's enrollment of 330 is above the median of 62 across 275 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients in good health (American Society of Anesthesiologists Class I or II).
  • Patients having symptomatic irreversible pulpitis in one of their mandibular molars.
  • Age range between 18 to 50 years.
  • Patients who can understand Numerical Rating Scale (NRS).
  • Positive patient acceptance and the ability to sign an informed consent.

Exclusion criteria

Exclusion Criteria:

  • Pregnant females.
  • Patients allergic to articaine, mepivacaine and/or any used medication or material.
  • Patients having active sites of pathosis in the area of injection.
  • Patients having active pain in more than one molar.
  • Patients who had taken analgesics in the 12 hours preceding treatment.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
330 participants (actual)

Study arms

  • Experimental
    Mepivacaine

    IANB using 3.6 ml of 2% mepivacaine hydrochloride with 1:100,000 epinephrine.

    Drug: Mepivacaine

  • Active comparator
    Articaine

    IANB using 3.4 ml of 4% articaine hydrochloride with 1:100,000 epinephrine.

    Drug: Articaine

Interventions

  • DrugMepivacaine

    IANB using 3.6 ml of 2% mepivacaine hydrochloride with 1:100,000 epinephrine.

  • DrugArticaine

    IANB using 3.4 ml of 4% articaine hydrochloride with 1:100,000 epinephrine.

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What researchers measure

Primary outcomes

  1. Anaesthetic success

    Success of mandibular inferior alveolar nerve block anesthesia during access cavity preparation and instrumentation measured using the 11-point numerical rating scale (NRS) so that no-or-mild pain is considered as anesthetic success and moderate-to-severe pain is considered anesthetic failure.

    Time frame: Intraoperative

Secondary outcomes

  1. Need for Supplemental anaesthesia

    The need for supplemental anaesthesia to complete treatment (Yes/No).

    Time frame: Intraoperative

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Allegretti CE, Sampaio RM, Horliana AC, Armonia PL, Rocha RG, Tortamano IP. Anesthetic Efficacy in Irreversible Pulpitis: A Randomized Clinical Trial. Braz Dent J. 2016 Jul-Aug;27(4):381-6. doi: 10.1590/0103-6440201600663. PubMed 27652697 ↗
  • Nagendrababu V, Pulikkotil SJ, Suresh A, Veettil SK, Bhatia S, Setzer FC. Efficacy of local anaesthetic solutions on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a systematic review and network meta-analysis of randomized clinical trials. Int Endod J. 2019 Jun;52(6):779-789. doi: 10.1111/iej.13072. Epub 2019 Feb 12. PubMed 30638269 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04822415
Lead sponsor
Cairo University
Responsible party
Suzan AW Amin (Professor, Cairo University) — Principal investigator
First posted
Mar 30, 2021
Start date
Dec 2014
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Aug 2, 2021

Study contacts

Randa ElBoghdadi, PhD
study director · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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