The Use of Infiltrative Anesthesia Instead of Inferior Alveolar Block

Infiltrative Anesthesia With Lidocaine Can Replace The Inferior Alveolar Nerve Block In Extraction of Devitalized Mandibular Molar Teeth

Generally it is accepted that infiltrative anesthesia (IA) is not sufficient for extraction of lower molars and that an inferior alveolar nerve block (IANB) is needed. In this study, it was aimed to compare the effectiveness of IANB and IA in extraction of devitalized mandibular molars.

Sixty subjects are randomly divided into study (n=30) and control (n=30) groups. Lidocaine with epinephrine is used for all injections. In the study group only vestibular and lingual IA will be used. In the control group, IANB will be applied. Teeth were extracted as usual. The pain felt during extraction will be compared.

Study Overview

• Status: Completed
• Conditions: Local Infiltration
• Intervention / Treatment: Drug: Lidocain

Detailed Description

It has been taught in dental curricula that using only infiltrative anesthesia (IA) is not sufficient for extraction of lower molars and that an inferior alveolar nerve block (IANB) is needed. However, it is also well-known that dental implants can be inserted into mandibular posterior region using only IA.

It can be claimed that there is no difference regarding the need for anesthesia between extracting a devitalized tooth and placing an implant in the same area. In this study, it was aimed to compare the effectiveness of IANB and IA in extraction of mandibular molars that had previously undergone root canal treatment.

The study is as a prospective, randomized, and non blinded clinical trial. All procedures are carried out at Necmettin Erbakan University, Faculty of Dentistry. The inclusion criteria are: age > 18 years, the tooth to be extracted is a mandibular first or second molar with a previously completed root canal treatment. The patients allergic to local anesthetics, those with severely mobile teeth, those had severe pain due to an acute infection, and the patients using psychotropic drugs are excluded.

Sixty subjects are randomly divided into study (n=30) and control (n=30) groups. An anesthetic solution containing 20 mg/mL of lidocaine and 0.0125 mg/mL of epinephrine was used in all subjects. In the study group only vestibular and lingual IA will be used. In the control group, IANB will be applied. The teeth will be extracted as usual. Using a visual analog scale (VAS), the pain felt during extraction will be separately recorded. Mann-Whitney U test will be used for statistical analysis. Statistical significance is defined as p<.05.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Necmettin Erbakan University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• the patient is older than 18 years
• the tooth to be extracted is a mandibular first or second molar with a previously completed root canal treatment

Exclusion Criteria:

• The patients allergic to local anesthetics
• Those with severely mobile teeth
• Those had severe pain due to an acute infection
• The patients using psychotropic drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anesthesia; In the first group, inferior alveolar anesthesia is used. In the second group, infiltrative anesthesia is used. In both groups, one dose of lidocaine HCl contained in 2 mL ampule is used. It is a standard drug.	Drug: Lidocain; Local anesthesia; Other Names: Lidocaine
Active Comparator: tooth extraction pain; In both groups, the patient is asked to evaluate the pain she/he experienced during the extraction. This evaluation is done immediately after the extraction, by using a "visual analogue scale" (detailed in other sections of this trial record).	Drug: Lidocain; Local anesthesia; Other Names: Lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale	This is a 100 mm linear scale used to measure pain. On the left end is a description: "No pain at all. On the right end, there is the description "The worst pain imaginable." The patient will be asked to mark the pain on this line and then the distance from the left end to the mark will be measured.	Immediately after the tooth extraction.

Collaborators and Investigators

• Sponsor: Konya Necmettin Erbakan Üniversitesi
• Investigators: Study Chair: Ali R Tunçdemir, PhD, Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: KonyaNEU 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No