Infiltration Anesthesia vs. Block Anesthesia (LAI)

April 5, 2025 updated by: Sinan A. Shwailiya

Effectiveness of Local Anesthetic Infiltration With Articaine 4% in Comparison to Inferior Alveolar Nerve Block With Lidocaine 2% for Mandibular 1st Molar Extraction

Checking the effectiveness of the infiltration technique of local anesthetic agent as an alternative to inferior dental nerve block during tooth extraction

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who need their Mandibular first Molar to be removed under local anaesthesia. The first group will receive 4% articaine with 1:100,000 epinephrine as lingual and buccal infiltration. In comparison, the second group will receive a conventional inferior alveolar nerve block technique with 2% lidocaine with epinephrine (1:80,000). Pain will be measured para-operatively using a verbal rating scale.

Study Type

Interventional

Enrollment (Actual)

100

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

  • Iraq
    • Babylon
      • Hilla, Babylon, Iraq, 00964
        • College of Dentistry, University of Babylon
      • Hilla, Babylon, Iraq, 00964
        • College of Dentistry/University of Babylon

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The systemic condition must be normal.
  • Patient has no cardiovascular, metabolic, or transmitted disease.
  • The patient has a Mandibular 1st. Molar tooth indicated for extraction.
  • The tooth is non-restorable.

Exclusion Criteria:

  • Chronic cardiovascular condition, metabolic, or infectious disease.
  • Pregnant women.
  • The tooth is restorable.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Block
This group will receive a conventional inferior alveolar nerve block (IANB) technique with 2% lidocaine with epinephrine (1:80,000) for tooth extraction.
Procedure: Inferior Alveolar Nerve Block
This group will receive a conventional inferior alveolar nerve block (IANB) technique with 2% lidocaine with epinephrine (1:80,000) for tooth extraction.
Other Names:
  • Regional Anaesthesia
Experimental: Infiltration
This group will receive 4% articaine with 1:100,000 epinephrine as lingual and buccal infiltration for tooth extraction
Procedure: Infiltration with Articain 4%
The experimental group of patients that are diagnosed for tooth extraction of mandibular 1st. molar will undergo extraction using an infiltration technique for local anaesthesia. In contrast to the conventional group that will receive Inferior alveolar nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal Pain Rating Scale
Time Frame: during the intervention/procedure/surgery

Pain during tooth extraction will be measured immediately after the procedure is completed using a verbal rating scale. The zero rate will be given when the patient feels no pain; the rating degree will increase as the pain severity becomes more severe. According to the following scale:

0 No hurt

  1. Slight pain
  2. Moderate pain
  3. Intense pain
  4. Extremely painful
during the intervention/procedure/surgery

Collaborators and Investigators

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

Sponsor

Sinan A. Shwailiya

Collaborators

Babylon University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 10, 2025

Primary Completion (Actual)

February 10, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

January 4, 2025

First Submitted That Met QC Criteria

January 4, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 5, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study DATA will be provided on request

IPD Sharing Time Frame

after research publishment

IPD Sharing Access Criteria

other researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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.

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