The Use of Infiltrative Anesthesia Instead of Inferior Alveolar Block

NCT06439186 | Completed Phase 4

• 1 other identifier: KonyaNEU 2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Local Infiltration

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Anesthesia

ACTIVE COMPARATOR

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

tooth extraction pain

ACTIVE COMPARATOR

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

Interventions

Lidocain DRUG

Local anesthesia

Also known as: Lidocaine

Anesthesia; tooth extraction pain

Eligibility Criteria

• Age: 19 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya Necmettin Erbakan Üniversitesi: lead

Study Sites (1)

Necmettin Erbakan University, Faculty of Dentistry

Konya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ali R Tunçdemir, PhD

  Necmettin Erbakan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: June 3, 2024
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: October 15, 2023
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)