| CTRI Number |
CTRI/2025/12/098308 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of effect of alkalized lidocaine versus non-alkalized lidocaine: A clinical trial
|
|
Scientific Title of Study
|
comparative evaluation anesthetic effect of alkalized lidocaine versus non-alkalized lidocaine administered in maxillary first molar with symptomatic irreversible pulpitis:
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 |
Apurva Borale |
| Designation |
post graduate student |
| Affiliation |
Dr.hsrsm dental college,basamba phata ,hingoli |
| Address |
department of conservative dentistry and endodontics Dr.hsrsm dental college,basamba phata ,hingoli
Hingoli
MAHARASHTRA
431513
India |
| Phone |
7972560032 |
| Fax |
|
| Email |
apurvasb31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
shachi goenka |
| Designation |
reader |
| Affiliation |
Dr.hsrsm dental college,basamba phata ,hingoli |
| Address |
Dr.hsrsm dental college,basamba phata ,hingoli
Hingoli
MAHARASHTRA
431513
India |
| Phone |
7972560032 |
| Fax |
|
| Email |
sunrays_gs@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Apurva Borale |
| Designation |
post graduate student |
| Affiliation |
Dr.hsrsm dental college,basamba phata ,hingoli |
| Address |
Department of conservative dentistry and endodontics Dr.hsrsm dental college,basamba phata ,hingoli
Hingoli
MAHARASHTRA
431513
India |
| Phone |
7972560032 |
| Fax |
|
| Email |
apurvasb31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr hedgewar smruti rugn seva mandals dental college hingoli |
|
|
Primary Sponsor
|
| Name |
Apurva Borale |
| Address |
Dr.hsrsm dental college,basamba phata ,hingoli 431513 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Apurva Borale |
department of conservative dentistry and endodontics Dr HSRSM dental college hingoli |
Dr hsrsm dental college,basamba phata hingoli
Hingoli
MAHARASHTRA |
7972560032
apurvasb31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. HSRSM DENTAL COLLEGE INSTITUTIONAL ETHICAL COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 percent lignocain as local anesthetic agent |
2 percent lignocain along with 1 in 80000 proportion adrenaline as local anesthetic agent |
| Intervention |
4.2 percent sodium bicarbonate |
2 percent lignocaine with 4.2% sodium bicarbonate in 1 in 10 proportion |
| Intervention |
8.4 percent sodium bicarbonate |
2 percent lignocaine with 8.4 percent sodium bicarbonate in 1 in 10 proportion |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Deep carious lesions having moderate to severe visual analogue scale score greater than 5
Aged from 16 to 45
With SIP in the mandibular molar was included
|
|
| ExclusionCriteria |
| Details |
Recent cardiac surgery, pregnancy or lactation
Premedication
Necrotic teeth with associated sinus tracts
Advanced periodontitis
Poor oral hygiene
Presence of dental fractures
Large periapical radiolucency greater than 2 mm
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effectiveness of Inferior Alveolar Nerve Block for pain relief in Symptomatic irreversible pulpitis using conventional and buffered lidocaine |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
00 |
|
|
Target Sample Size
|
Total Sample Size="141"
Sample Size from India="141"
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)
|
15/12/2025 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 study is a Randomized ,Double Blinded Parellel Group clinical Trial evaluating the anesthetic effect of alkalized lidocaine versus non-alkalized lidocaine administered in maxillary first molar with symptomatic irreversible pulpitis that will be conducted in Dr HSRSM dental college Hingoli India |