The Use of Infiltrative Anesthesia Instead of Inferior Alveolar Block

Local Infiltration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06439186
• Other study ID #: KonyaNEU 2
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2022
• Est. completion date: October 15, 2023

Study information

• Verified date: May 2024
• Source: Konya Necmettin Erbakan Üniversitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 15, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 62 Years

Eligibility

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

Related Conditions & MeSH terms

• Local Infiltration

Intervention

Drug:
• Lidocain
Local anesthesia

Locations

Country	Name	City	State
Turkey	Necmettin Erbakan University, Faculty of Dentistry	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Necmettin Erbakan Üniversitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.