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CTRI Number  CTRI/2024/09/073787 [Registered on: 11/09/2024] Trial Registered Prospectively
Last Modified On: 18/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Efficacy of Angulated Needle for IANB over conventional techniques. 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akash Mandal 
Designation  Post Graduate Student 
Affiliation  KAHER KLE Vishwanath Katti Institute of Dental Sciences 
Address  Department of Oral and Maxillofacial surgery ,KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  8240927067  
Fax    
Email  akashmandal0397@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Akash Mandal 
Designation  Post Graduate Student 
Affiliation  KAHER KLE Vishwanath Katti Institute of Dental Sciences 
Address  Department of Oral and Maxillofacial surgery ,KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar Belgaum KARNATAKA 590010 India


KARNATAKA
590010
India 
Phone  8240927067  
Fax    
Email  akashmandal0397@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjay S Rao 
Designation  PROFESSOR 
Affiliation  KAHER KLE Vishwanath Katti Institute of Dental Sciences 
Address  Department of Oral and Maxillofacial surgery ,KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9845454266  
Fax    
Email  sanjsamuel@yahoo.com  
 
Source of Monetary or Material Support  
KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, 590010, Karnataka, India 
 
Primary Sponsor  
Name  Akash Mandal 
Address  Department of Oral and Maxillofacial surgery ,KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar Belgaum KARNATAKA 590010 India 
Type of Sponsor  Other [self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akash Mandal  KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus  Department of Oral and Maxillofacial surgery ,KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar Belgaum KARNATAKA 590010 Belgaum KARNATAKA
Belgaum
KARNATAKA 
8240927067

akashmandal0397@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Angulated Needle Approach Technique  Extraction of mandibular teeth with angulated technique for inferior alveolar nerve block. Expected to be much efficient (more than 80%: under 2 mins) and have a more success rate than the conventional/ comparator methods. 
Comparator Agent  Fischer 1-2-3 technique  Extraction of mandibular teeth with conventional indirect technique for inferior alveolar nerve block 
Comparator Agent  Halsted technique  Extraction of mandibular teeth with conventional direct technique for inferior alveolar nerve block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. 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.  
 
ExclusionCriteria 
Details  1.Patient diagnosed with periapical abcess, dentoalveolar abcess of mandibular teeth.
2.Mentally challenged patients or patients with Learning disability.
3. Patients with history of allergy to Local Anesthetic solution, foods, drugs,
4. Alcoholics or drug abusers.
5. Patients on antidepressants, anti-anginal and anti-anxiety drugs.
6. Patients who had taken painkillers in the past 24 hours.
7. Patients who are afraid of undergoing oral surgical treatment.
9. Patient not willing to participate in study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
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) 
At the time of Treatment (Day Zero) 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the preoperative, intraoperative and postoperative pain and discomfort levels
using the NRS (Numerical Rating Scale) 
At the time of Treatment (Day Zero) 
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
Final Enrollment numbers achieved (Total)= "93"
Final Enrollment numbers achieved (India)="93" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   22/09/2024 
Date of Study Completion (India) 20/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/12/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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)

 

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

 
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