NCT05238727

Brief Summary

To assess the anesthetic success of inferior alveolar nerve block (IANB), intraoperative pain intensity and need for supplemental anesthesia on administration of 1.8ml or 3.6ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine buccal infiltration (BI) in mandibular molars with symptomatic irreversible pulpitis.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

February 3, 2022

Last Update Submit

February 11, 2022

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

  • Anesthetic success

    Will be recorded by 11-point numerical rating scale (NRS) consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain". Success will be defined as no to mild pain.

    During the treatment

Secondary Outcomes (2)

  • Intraoperative pain

    During the treatment

  • Need for supplemental anesthesia

    During the treatment

Study Arms (3)

1.8 ml mepivacaine IANB

ACTIVE COMPARATOR
Drug: 1.8 ml mepivacaine hydrochloride

3.6 ml mepivacaine IANB

EXPERIMENTAL
Drug: 3.6 ml mepivacaine hydrochloride

1.8 ml mepivacaine IANB plus 1.8 ml articaine BI

EXPERIMENTAL
Drug: 1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI

Interventions

1.8 ml mepivacaine hydrochlorideDRUG

1.8 ml mepivacaine IANB

1.8 ml mepivacaine IANB
3.6 ml mepivacaine hydrochlorideDRUG

3.6 ml mepivacaine IANB

3.6 ml mepivacaine IANB
1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BIDRUG

1.8 ml mepivacaine IANB plus 1.8 ml articaine BI

1.8 ml mepivacaine IANB plus 1.8 ml articaine BI

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients in good health (ASA Class I, II).
  • Age between 18-60 years old.
  • Males or females.
  • Mandibular molar teeth diagnosed with symptomatic irreversible pulpitis.
  • Patients who can understand NRS scale and sign the informed consent.

You may not qualify if:

  • Patients who had used any type of analgesic medication during the preceding 8 hours before the treatment.
  • Pregnant or nursing females.
  • Patients with a contraindication for the use of mepivacaine, articaine or any used drug or material.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Abazarpoor R, Parirokh M, Nakhaee N, Abbott PV. A Comparison of Different Volumes of Articaine for Inferior Alveolar Nerve Block for Molar Teeth with Symptomatic Irreversible Pulpitis. J Endod. 2015 Sep;41(9):1408-11. doi: 10.1016/j.joen.2015.05.015. Epub 2015 Jul 3.

    PMID: 26149210BACKGROUND

  • Aggarwal V, Singla M, Miglani S, Kohli S, Singh S. Comparative evaluation of 1.8 mL and 3.6 mL of 2% lidocaine with 1:200,000 epinephrine for inferior alveolar nerve block in patients with irreversible pulpitis: a prospective, randomized single-blind study. J Endod. 2012 Jun;38(6):753-6. doi: 10.1016/j.joen.2012.02.003. Epub 2012 Mar 3.

    PMID: 22595107BACKGROUND

  • Parirokh M, Satvati SA, Sharifi R, Rekabi AR, Gorjestani H, Nakhaee N, Abbott PV. Efficacy of combining a buccal infiltration with an inferior alveolar nerve block for mandibular molars with irreversible pulpitis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Mar;109(3):468-73. doi: 10.1016/j.tripleo.2009.11.016.

    PMID: 20219602BACKGROUND

MeSH Terms

Interventions

Mepivacaine

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Reham Anwar Sleem

CONTACT

00201014110666reham.anwar@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms

Study Record Dates

First Submitted

February 3, 2022

First Posted

February 14, 2022

Study Start

March 1, 2022

Primary Completion

March 1, 2023

Study Completion

September 1, 2023

Last Updated

February 14, 2022

Record last verified: 2022-02