| CTRI Number |
CTRI/2025/03/082128 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
09/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
This study tests three different ways to numb the pain in patients whose first pain relief shot didn’t work during molar treatments. The goal is to find the best method to make the procedure pain-free. |
|
Scientific Title of Study
|
Comparative evaluation of the Anesthetic efficacy of 4 Percent Articaine using 3 different supplemental injection techniques in Mandibular 1st Molar after failed Inferior Alveolar Nerve Block- A Randomised Clinical 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 |
Sandhi Jaswal |
| Designation |
Post Graduate student |
| Affiliation |
Bhojia Dental College and Hospital |
| Address |
VPO and Tehsil Lad Bharol
Dist Mandi, Himachal Pradesh
Department No 7
Conservative Dentistry and Endodontics
Bhojia Dental College and Hospital, Budh, Baddi
Solan
HIMACHAL PRADESH
176126
India |
| Phone |
9418441088 |
| Fax |
|
| Email |
sandhijaswal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amita |
| Designation |
Professor |
| Affiliation |
Bhojia Dental College and Hospital |
| Address |
Department No 7
Conservative Dentistry and Endodontics
Bhojia Dental College and Hospital
Bhojia Dental College and Hospital, Budh, Baddi
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
9878027370 |
| Fax |
|
| Email |
amitapsk2002@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandhi Jaswal |
| Designation |
Post Graduate student |
| Affiliation |
Bhojia Dental College and Hospital |
| Address |
VPO and Tehsil Lad Bharol
Dist Mandi, Himachal Pradesh
Department No 7
Conservative Dentistry and Endodontics Bhojia Dental College and Hospital, Budh, Baddi
Solan
HIMACHAL PRADESH
176126
India |
| Phone |
9418441088 |
| Fax |
|
| Email |
sandhijaswal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self
Department No 7
Conservative Dentistry and Endodontics
Bhojia Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Sandhi Jaswal |
| Address |
Department No 7
Coservative Dentistry and Endodontics
Bhojia Dental College and Hospital, Budh, Baddi, Dist Solan , Himachal Pradesh
173205 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sandhi Jaswal |
Bhojia Dental College and Hospital |
Department No 7
Conservative Dentistry and Endodontics
Bhojia Dental College and Hospital, Budh, Baddi
Solan
HIMACHAL PRADESH |
9418441088
sandhijaswal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Bhojia Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Buccal Infiltration, Intraligamentary Injection and Intrapulpal Injection |
Patients fulfilling the inclusion criteria will be given a supplemental anesthetic after a failed inferior alveolar nerve block. This part of the study is a three arm, parallel group, double blind, randomised clinical trial. The three groups assigned are:
Group A (Buccal infiltration): This group comprises of 20 subjects in which a supplemental Buccal infiltration will be given after a failed Inferior Alveolar Nerve Block
Group B (Intraligamentary Injection): This group comprises of 20 subjects in which a supplemental Intraligamentary Injection will be given after a failed Inferior Alveolar Nerve Block
Group C (Intrapulpal Injection): This group comprises of 20 subjects in which a supplemental Intrapulpal Injection will be given after a failed Inferior Alveolar Nerve Block. The supplemental injection will be given 15 minutes after the IANB
|
| Intervention |
Inferior Alveolar Nerve Block with 2 percent Lidocaine |
Patient is first given IANB with 2 percent Lidocaine and the supplemental anesthesia with 4 percent Articaine using Buccal Infiltration, Intraligamentary Injection and Intrapulpal Injection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient experiencing spontaneous and moderate to severe pain in mandibular 1st Molar diagnosed with symptomatic irreversible pulpitis
2. Patients in the age group of 18-60 years 3. Mature teeth with closed apex
4. Teeth with healthy periodontium |
|
| ExclusionCriteria |
| Details |
1. Patients with History of significant medical conditions
2. Patient allergic to local anesthesia or sulfides
3. Pregnant women
4. Patients having active sites of pathosis in the area of injection
5. No bleeding after access opening
6. Teeth with periapical radiolucency
7. Patients who consumed medications like analgesics, narcotics, sedation, antianxiety or antidepressants before the treatment
8. Patients having any other region of active pain in the same quadrant along with mandibular 1st molar |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain assessment will be conducted following the administration of a supplemental anesthetic injection after a failed inferior alveolar nerve block, during access opening, initial file placement and instrument the tooth using a 10-point pain intensity scale post-treatment. |
The Supplemental Injection will be given 15 minutes after the IANB. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
To assess the anesthetic efficacy of 4% articaine using supplemental Buccal Infiltration, Intraligamentary injection and Intrapulpal injection in mandibular 1st molar after failed Inferior Alveolar Nerve Block. |