| CTRI Number |
CTRI/2026/04/107927 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing the effectiveness of a numbing injection with and without an oral painkiller for toothache treatment in lower molar teeth A randomized clinical trial |
|
Scientific Title of Study
|
Comparative evaluation of anaesthetic efficacy of 0.5 percentage bupivacaine with oral diclofenac potassium vs 0.5 percentage bupivacaine on inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular first molar A prospective randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vivek Kalluri |
| Designation |
Post graduate student |
| Affiliation |
Government dental college and hospital mumbai |
| Address |
Government dental college and hospital mumbai ,room no 101,sentz George medical college campus,near CSTM,fort area
Mumbai
MAHARASHTRA
400001
India |
| Phone |
7499423469 |
| Fax |
|
| Email |
vivekkalluri0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Abrar Sayed |
| Designation |
Head of Department, Department of Conservative Dentistry and Endodontics |
| Affiliation |
Government dental college and hospital mumbai |
| Address |
Government dental college and hospital mumbai ,room no 101,sentz George medical college campus,near CSTM,fort area
Mumbai (Suburban)
MAHARASHTRA
400001
India |
| Phone |
7499423469 |
| Fax |
|
| Email |
abrars79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vivek Kalluri |
| Designation |
Post graduate student |
| Affiliation |
Government dental college and hospital mumbai |
| Address |
Government dental college and hospital mumbai ,room no 101,sentz George medical college campus,near CSTM,fort area
MAHARASHTRA
400001
India |
| Phone |
7499423469 |
| Fax |
|
| Email |
vivekkalluri0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and hospital mumbai, Department of Conservative Dentistry and Endodontics,Room no 101,
sentz George hospital campus, near CSTM, fort area
state maharashtra, district mumbai suburban, country INDIA
pin 400001 |
|
|
Primary Sponsor
|
| Name |
Vivek Manohar Kalluri |
| Address |
Government dental college and hospital mumbai near csmt area fort pin 400001 |
| 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 Abrar Sayed |
Government dental college and hospital mumbai |
Department of Conservative Dentistry and Endodontics
Division Endodontics
Room no 101 First floor
Mumbai (Suburban)
MAHARASHTRA |
96199 42159
abrars79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Government dental college and hospital mumbai |
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 |
| Intervention |
Bupivacaine 0.5 percentage plus Diclofenac Potassium 50 mg |
Bupivacaine o.5 percentage manufactured from anavin Anawin 0.5 percentage Injection is a prescription medication used as a local anesthetic. It is used during minor surgical procedures such as dental, oral, diagnostic, or other therapeutic procedures to anesthetize or numb the surgical area
Diclofenac Potassium 50 mg
DENSAID
Safetab Life Science Puducherry-605 Ic7, India
Country of Origin
India |
| Comparator Agent |
bupivacaine 0.5 percentage plus lactose powder |
Anawin Bupivacaine injection 0.5 percentage strength is available in 20ml vials, manufactured by Neon, and is used as a local anesthesia to numb areas during or after surgery, childbirth, or dental work, for up to 72 hours post-surgery. stored at 20-25 degree Celcious |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy patients over 18 years old with Symptomatic irreversible pulpitis in first
mandibular molar tooth
Patients who had not taken any analgesics within 6 hours before endodontic treatment.
Patient willing to participate |
|
| ExclusionCriteria |
| Details |
History of allergies or sensitivity to Diclofenac Potassium
History of known allergies or sensitivity to bupivacaine
History of anti-coagulant drug therapy
History of central nervous system depressants therapy
Pregnant or lactating females,
History of active peptic ulcer within the preceding 12 months,
Bleeding problems or bleeding disorders
Not willing to participate.
History of significant medical problems (American Society of Anaesthesiologists class III
or higher)
History of ventricular arrhythmias, hypotension, hypertension, bradycardia,
hemodynamic instability, and cardiovascular collapse |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the assessment of anaesthetic efficacy by comparing pain scores between the two groups using the Heft-Parker Visual Analog Scale (VAS). Successful anaesthesia is defined as the absence of pain or mild pain (0-4 on the VAS) during access cavity preparation and the first file placement in the distal canal. Failure is recorded if the patient experiences moderate to severe pain (5 or more than 5 on the VAS) at any point during the procedure. |
Pain scores will be assessed at the following four time points:
1. Baseline (5 minutes before premedication)
2. 20 minutes after inferior alveolar nerve block administration
3. During access cavity preparation
4. During first file placement in the distal canal of the mandibular first molar
Additionally, patients will be followed up at 24-48 hours post-treatment to evaluate flare-ups and post-operative pain. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/04/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This prospective randomized double blind clinical trial aims to compare the anaesthetic efficacy of 0.5 percent bupivacaine with oral diclofenac potassium versus 0.5 percent bupivacaine alone for inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular first molars. A total of 60 patients will be randomly allocated into two groups of 30 each. The experimental group will receive a single oral dose of 50 mg diclofenac potassium one hour before administration of inferior alveolar nerve block with 0.5 percent bupivacaine. The control group will receive a placebo tablet one hour before administration of inferior alveolar nerve block with 0.5 percent bupivacaine. Pain scores will be recorded using the Heft Parker Visual Analog Scale at four time points before premedication after local anesthesia during access cavity preparation and during first file placement. Successful anaesthesia is defined as no pain or mild pain on the VAS scale. Patients aged over 18 years with symptomatic irreversible pulpitis in mandibular first molars who have not taken analgesics within six hours will be included. Patients with allergies to diclofenac or bupivacaine bleeding disorders pregnancy or significant medical conditions will be excluded. |