The Use of Infiltrative Anesthesia Instead of Inferior Alveolar Block

NCT ID: NCT06439186

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-10-15

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.

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.

Conditions

Local Infiltration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Lidocain

Intervention Type: DRUG

Local anesthesia

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).

Group Type: ACTIVE_COMPARATOR

Lidocain

Intervention Type: DRUG

Local anesthesia

Interventions

Lidocain

Local anesthesia

Intervention Type: DRUG

Other Intervention Names

Lidocaine

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 62 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Konya Necmettin Erbakan Üniversitesi

OTHER

Sponsor Role: lead

Responsible Party

Kubilay Isik

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali R Tunçdemir, PhD

Role: STUDY_CHAIR

Necmettin Erbakan University

Locations

Necmettin Erbakan University, Faculty of Dentistry

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KonyaNEU 2

Identifier Type: -

Identifier Source: org_study_id