| 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
|
|
|
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
|
|
|
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:
• 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). |