Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06439186 |
Other study ID # |
KonyaNEU 2 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.