Comparing Buccal Infiltration and Inferior Alveolar Nerve Block for Extraction of Mandibular Teeth

September 28, 2023 updated by: Abdul Kalam Azad, Melaka Manipal Medical College

Effectiveness of Buccal Infiltration and Inferior Alveolar Nerve Block With Articaine for Extraction of Mandibular Teeth- A Randomized Clinical Trial

This study compares the effectiveness of two techniques of local anesthesia in the extraction of mandibular teeth. One group received inferior alveolar nerve block and the other group received buccal infiltration of 4% Articaine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inferior alveolar nerve block is the commonly used local anesthetic injection technique for extraction of mandibular teeth. Buccal infiltration technique alone is considered to be ineffective in treating mandibular teeth due to the thickness of buccal cortical plate. However, buccal infiltration, if provided with an agent with higher penetration capability, may be used instead of Inferior alveolar nerve block. Articaine, due to its thiophene ring, has higher liposolubility and bony diffusion than any other agent.

This study compares the effectiveness of inferior alveolar nerve block and buccal infiltration using 4% Articaine in the extraction of mandibular teeth

Study Type

Interventional

Enrollment (Actual)

60

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

  • Malaysia
      • Melaka, Malaysia, 75150
        • Melaka Manipal Medical College

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Mandibular teeth
  • grossly decayed teeth
  • root stumps
  • therapeutic extractions
  • American society of anesthesiologist classification I & II patients

Exclusion Criteria:

  • patients allergic to local anesthesia
  • infected teeth
  • grade 2 and grade 3 mobile teeth
  • patients already taking medications which influences the anaesthetic assessment

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Buccal infiltration of 4% Articaine
Procedure: Buccal infiltration
Injection of local anaesthetic parallel to the Long axis of the tooth in the depth of buccal sulcus
Active Comparator: Group B
Inferior alveolar nerve block of 4% Articaine
Procedure: Inferior alveolar nerve block
Standard technique of mandibular nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Requirement of rescue injection
Time Frame: During extraction
whether a recue injection was given or not
During extraction
Pain during injection using a visual analogue scale measuring 10 cm with 0 depicting no pain and 10 depicting severe pain
Time Frame: During injection
VAS scale is a validated scale measuring pain with possible score range from 0 (no pain) to 10 (severe pain).
During injection
Pain during extraction using a visual analogue scale measuring 10 cm with 0 depicting no pain and 10 depicting severe pain
Time Frame: During extraction
VAS scale is a validated scale measuring pain with possible score range from 0 (no pain) to 10 (severe pain).
During extraction

Collaborators and Investigators

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

Sponsor

Melaka Manipal Medical College

Investigators

  • Study Director: Abdul R Ismail, Melaka Manipal Medical College

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 1, 2019

Primary Completion (Actual)

January 30, 2020

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (Actual)

March 4, 2020

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MMMC/FOD/AR/B7/E C-2019 (04)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

1 month

IPD Sharing Access Criteria

Study protocol will be provided only if requested through a proper channel , dean of the college, with proper justification.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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