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Clinical Trials/CTRI/2024/09/073787
CTRI/2024/09/073787CompletedPhase 3

Assessment of anesthetic efficacy of Angulated Needle Approach, Halsted and Fischer 1-2-3 inferior alveolar nerve block technique for extraction of mandibular teeth- a Randomized Control Trial

Akash Mandal1 site in 1 country93 target enrollmentStarted: September 22, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
93
Locations
1
Primary Endpoint
To evaluate the anesthetic efficiency of angulated needle approach, Halsted and Fischer 1-

Study Overview

Brief Summary

NEED FOR THE STUDY:

 Local Anesthesia is one of the most essential steps when it comes to dental surgery. It helps in reducing the pain and discomfort arising due to the surgical procedure helping both the clinician and patient to go through a painless and relieving procedure.

 Anesthesia for the lower lip, mandibular teeth, and mandibular gingivae are produced using the inferior alveolar nerve block (IANB) anesthesia method.

 The two most commonly used inferior alveolar nerve block technique is the conventional direct technique which is also known as Halsted’s technique involves placement of the syringe loaded with local anesthetic solution into the pterygomandibular space which is closely related to mandibular foramen. This space when filled with LA provides anesthesia for the inferior alveolar nerve block (IANB) and the lingual nerve block (LNB), with supplemental buccal nerve anaesthesia (BN) and an indirect technique or Fischer’s 1-2-3 technique.

 In clinical practice, however the success rates for these techniques are quite low even when it is performed by an experienced clinician. The two techniques depend on the knowledge of the clinician, requires exact technique and proper understanding of the anatomy. The clinician must know the exact site on the buccal mucosa for the puncture of the needle relative to mandibular foramen for the LA to act properly on the nerve.

 Studies have shown failures in attaining local anesthesia while performing nerve blocks especially inferior alveolar nerve block. Ninety percent of the dentists reported some anesthetic failure during restorative visits. General practitioners responding to the survey reported 13.1% failure. The rate of failure for individual dentists ranged from 0% to 48.6%. In almost all cases the dentist gave an additional injection after the initial failure. Eighty-eight percent of dentists who had failures reported at least one mandibular block fail.

 Clinicians every now and then struggle to achieve desired anesthetic results from the conventional technique (as success rates is not that much satisfying) and thus many have tried to contribute new methods/techniques to enhance the success rates for inferior alveolar nerve block.

 This indicates several interesting factors. The closer the needle tip placement to the mandibular foramen, the more likely the success of the mandibular block injection.

 Studies have been done to reduce the failure rates where authors have described a method of inferior alveolar nerve block (IANB) by injecting a local anesthetic solution into the pterygomandibular space by arching the needle and changing the approach angle of the conventional technique. u While some authors have tried to implement straight needle single path approach where the needle punctures the site once and deposits the anesthetic solution at different depth anesthetizing the inferior alveolar, lingual and buccal nerve.

 In this study, we aim to compare the accuracy and anesthetic effectiveness of the angulated needle approach, a new technique for IANB with that of the conventional direct and indirect technique i.e Halsted and Fischer’s technique respectively, both intra-operative and post[1]operatively during and after extraction of indicated teet

 OBJECTIVES:

ʉۢ To evaluate the anesthetic efficiency of angulated needle approach, Halsted and Fischer 1- 2-3 inferior alveolar nerve block technique in patients undergoing surgical extraction of mandibular teeth under local anesthesia by assessing QAS score (quality of anesthesia score)

ʉۢ To assess the preoperative, intraoperative and postoperative pain and discomfort levels using the NRS (Numerical Rating Scale).

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients with a complain of pain in mandibular teeth and is indicated for extraction.
  • 2.Both male and female patients.
  • 3.Patients between 18 to 65 years 4..ASA I & II 5.Patients willing to give informed consent.

Exclusion Criteria

  • 1.Patient diagnosed with periapical abcess, dentoalveolar abcess of mandibular teeth.
  • 2.Mentally challenged patients or patients with Learning disability.
  • Patients with history of allergy to Local Anesthetic solution, foods, drugs,
  • Alcoholics or drug abusers.
  • Patients on antidepressants, anti-anginal and anti-anxiety drugs.
  • Patients who had taken painkillers in the past 24 hours.
  • Patient not willing to participate in study.

Outcomes

Primary Outcomes

To evaluate the anesthetic efficiency of angulated needle approach, Halsted and Fischer 1-

Time Frame: At the time of Treatment (Day Zero)

2-3 inferior alveolar nerve block technique in patients undergoing surgical extraction of

Time Frame: At the time of Treatment (Day Zero)

mandibular teeth under local anesthesia by assessing QAS score (quality of anesthesia

Time Frame: At the time of Treatment (Day Zero)

score)

Time Frame: At the time of Treatment (Day Zero)

Secondary Outcomes

  • To assess the preoperative, intraoperative and postoperative pain and discomfort levels(using the NRS (Numerical Rating Scale))

Investigators

Sponsor
Akash Mandal
Sponsor Class
Other [self funded]
Responsible Party
Principal Investigator
Principal Investigator

Akash Mandal

KAHER KLE Vishwanath Katti Institute of Dental Sciences

Study Sites (1)

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