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Volume Increase Versus Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success

Primary Purpose

Symptomatic Irreversible Pulpitis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

1.8 ml mepivacaine hydrochloride

3.6 ml mepivacaine hydrochloride

1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI

About this trial

This is an interventional prevention trial for Symptomatic Irreversible Pulpitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

1.8 ml mepivacaine IANB

3.6 ml mepivacaine IANB

1.8 ml mepivacaine IANB plus 1.8 ml articaine BI

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intraoperative pain

Need for supplemental anesthesia

Whether the patient requires supplemental anesthesia or not

Full Information

NCT ID

NCT05238727

First Posted

February 3, 2022

Last Updated

February 11, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05238727

Brief Title

Volume Increase Versus Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success

Official Title

Effect of Volume Increase Compared to Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success in Cases With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 2022 (Anticipated)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Patients with moderate-to-severe preoperative pain related to mandibular molars with symptomatic irreversible pulpitis will be included. Patients receive 1.8 ml, 3.6 ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine BI. Anesthetic success of inferior alveolar nerve block, intraoperative pain intensity and need for supplemental anesthesia will be assessed during treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Symptomatic Irreversible Pulpitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1.8 ml mepivacaine IANB

Arm Type

Active Comparator

Arm Title

3.6 ml mepivacaine IANB

Arm Type

Experimental

Arm Title

1.8 ml mepivacaine IANB plus 1.8 ml articaine BI

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

1.8 ml mepivacaine hydrochloride

Intervention Description

1.8 ml mepivacaine IANB

Intervention Type

Drug

Intervention Name(s)

3.6 ml mepivacaine hydrochloride

Intervention Description

3.6 ml mepivacaine IANB

Intervention Type

Drug

Intervention Name(s)

1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI

Intervention Description

1.8 ml mepivacaine IANB plus 1.8 ml articaine BI

Primary Outcome Measure Information:

Title

Anesthetic success

Description

Time Frame

During the treatment

Secondary Outcome Measure Information:

Title

Intraoperative pain

Description

Time Frame

During the treatment

Title

Need for supplemental anesthesia

Description

Whether the patient requires supplemental anesthesia or not

Time Frame

During the treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Reham Anwar Sleem

Phone

00201014110666

reham.anwar@dentistry.cu.edu.eg

12. IPD Sharing Statement

Citations:

PubMed Identifier

26149210

Citation

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.

Results Reference

background

PubMed Identifier

22595107

Citation

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.

Results Reference

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PubMed Identifier

20219602

Citation

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.

Results Reference

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Volume Increase Versus Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success

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