Buccal Infiltration Anesthesia Versus Inferior Alveolar Nerve Block Anesthesia

November 13, 2022 updated by: marwa aly fouad elchaghaby, Cairo University

Comparative Evaluation of the Effectiveness of Buccal Infiltration Anesthesia Versus Inferior Alveolar Nerve Block Anesthesia for the Extraction of Primary Mandibular Molars: A Randomized Controlled Study

This study aims to evaluate the effectiveness of single buccal local infiltration when compared to buccal local infiltration with intrapapillary infiltration and inferior alveolar nerve block anesthesia in primary mandibular molar extractions.

Study Overview

Detailed Description

Effective pain control is essential in providing children with successful dental treatment. Without it, negative experiences may result in anxiety and fear-related behaviors towards subsequent dental treatment. Local anesthesia is the cornerstone of pain control in dentistry. Choosing the right local anesthetic technique is of special significance .

The inferior alveolar nerve block (IANB) is a common practice for anesthetizing mandibular molars and/or premolars on one side of the jaw. It is achieved by depositing local anesthetic solution at the entrance to the mandibular canal, which inhibits the transmission of action potentials along the inferior alveolar nerve.

Administering an IANB can be technique sensitive and failure rates are reported to be up to 20%, due to anatomical variations in the position of the mandibular foramen and accessory innervations. This effect may be compounded for those who are not used to anesthetizing children .

However, Supraperiosteal infiltration has the advantages of easier administration when compared to block anesthesia, shorter anesthetic duration, and generally does not anesthetize the lips .

An ideal local anesthetic should provide maximum efficacy, through a minimal number of injections, using techniques that provide the least discomfort, causing negligible adverse effects .

Study Type

Interventional

Enrollment (Actual)

112

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

      • Cairo, Egypt
        • Cairo University

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

5 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Badly decayed primary mandibular molars indicated for extraction with not less than half of the root length present.
  • Children ranging in age from 5-8 years

Exclusion Criteria:

.Allergies to local anesthetics.

  • History of significant medical conditions.
  • Children under any medications.
  • Presence of abscess, sinus opening.
  • Uncooperative children without access to or with difficulty accessing dental care.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single buccal infiltration of articaine anesthesia
The local anesthetic solution will be administered using single buccal infiltration with articaine anesthesia.
injecting local anaesthetic solution into the soft tissues of the buccal sulcus adjacent to the target tooth.
Other Names:
  • Articaine buccal infiltration
Active Comparator: Inferior alveolar nerve block of lidocaine anesthesia
The anesthetic solution will be administered using inferior alveolar nerve block with lidocaine anesthesia.
Injection of local anesthetic solution into the pterygomandibular space to access the inferior alveolar nerve before it enters the mandible.
Other Names:
  • Lidocaine nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of intraoperative pain
Time Frame: through treatment completion, an average of 1 hour
Wong Baker Faces Pain Rating Scale consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears with numerical value from 0 to 5 where where zero indicates no pain and 5 indicate severe pain
through treatment completion, an average of 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative pain
Time Frame: through treatment completion, an average of 1 hour
Faces, Legs, Activity, Cry, and Consolability scale with score from 0 to 10 where zero indicates no pain and 10 indicate severe pain
through treatment completion, an average of 1 hour
The onset of the anesthetic effect
Time Frame: up to 24 hours
stopwatch
up to 24 hours
duration of the anesthetic effect
Time Frame: up to 24 hours
stopwatch
up to 24 hours

Collaborators and Investigators

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

Investigators

  • Principal Investigator: marwa m elchaghaby, phd, marwaaly2003@yahoo.com

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)

September 1, 2021

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 3, 2022

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 2, 2022

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 13, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

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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