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

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: Buccal Infiltration Inferior Alveolar Nerve Block Articaine
• Intervention / Treatment: Procedure: Buccal infiltration; Procedure: Inferior alveolar nerve block

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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	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	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	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

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

Study record dates

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: Buccal infiltration inferior alveolar nerve block Articaine
• 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