Comparative Assessment of Mental/Incisive and Inferior Alveolar Nerve Block Anesthesia in Root Canal Treatment of Mandibular Premolars

November 8, 2024 updated by: Tolga Sulek, Cukurova University

Anesthetic Effectiveness of Mental/incisive Nerve Block Versus Inferior Alveolar Nerve Block in Mandibular I. and II. Premolars with Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial

The goal of this clinical trial is to systematically compare the pain scores and anesthesia efficacy of IANB and MNB in the treatment of symptomatic mandibular first and second premolars. This study aims to address gaps in current evidence and clarify whether these anesthesia techniques differ in effectiveness and patient experience during endodontic procedures. The hypotheses include: (i) no difference in pain perception between IANB and MNB, (ii) no difference between first and second premolars with IANB, and (iii) no difference between first and second premolars with MNB.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01380
        • Cukurova University Dentistry Faculty Department of Endodontics Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals classified as ASA 1 or ASA 2.
  • Age range of 18 to 65 years.
  • No known allergies to articaine or epinephrine.
  • Absence of facial paresthesia.
  • No use of analgesic medications within 6 hours prior to treatment.
  • No use of medications, such as tricyclic antidepressants or beta blockers, that may interfere with anesthesia.
  • No pathological conditions at the planned injection site.
  • Periodontal pocket depth of 3 mm or less.
  • Mandibular first or second premolars diagnosed with symptomatic irreversible pulpitis.
  • Teeth meeting Glickman's gingival health criteria upon periodontal examination.
  • Radiographically closed root apex with no detectable pathology.
  • Patients must be literate and able to comprehend the use of a pain scale to provide informed consent voluntarily.

Exclusion Criteria:

  • Presence of systemic conditions contraindicating endodontic treatment. Age below 18 or above 65 years.
  • Pregnancy.
  • Documented allergy to articaine with 1:100,000 epinephrine.
  • Evidence of periapical pathology or radiolucency observed in radiographs.
  • Recent use of central nervous system depressants or analgesic medication within 6 hours prior to treatment.
  • Absence of reported lip numbness 10 minutes following IANB or MINB injection. Presence of a large restoration on the affected tooth.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inferior Alveoler Nerve Block
Other: inferior alveolar nerve block with 4% articaine
A single ampoule of 4% articaine was administered to a cohort of patients presenting with irreversible pulpitis in the first or second mandibular premolars, designated for Inferior Alveolar Block anesthesia via the mandibular foramen.
Experimental: Mental/Incisive Nerve Block
Other: Mental/Incisive Nerve Block (%4 Articaine)
A single ampoule of 4% articaine was administered to a cohort of patients presenting with irreversible pulpitis in the first or second mandibular premolars, designated for Mental or Incisive Nerve Block anesthesia via the mental foramen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale
Time Frame: Following anesthesia administration, a 10-minute waiting period was observed. Patients completed a Numerical Rating Scale immediately upon initiation of the endodontic cavity procedure and again after the start of pulp extirpation.
The patients were asked to rate the pain experienced during endodontic access cavity preparation and pulp extirpation using a Numerical Rating Scale. The Numerical Rating Scale was printed on A4 paper, scaled to fit horizontally, with values from 0 to 10 displayed along a bar. The Numerical Rating Scale uses a 0 to 10 scale, with increments of one unit. Patients were instructed to mark '0' if they experienced no pain, select a value between "1" and "3" for mild pain, a value between "4" and "6" for moderate pain, and a value between "7" and "10" for severe pain.
Following anesthesia administration, a 10-minute waiting period was observed. Patients completed a Numerical Rating Scale immediately upon initiation of the endodontic cavity procedure and again after the start of pulp extirpation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Actual)

September 15, 2024

Study Completion (Actual)

September 15, 2024

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 8, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/130/86

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mandibular Nerve

Clinical Trials on inferior alveolar nerve block with 4% articaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe