| CTRI Number |
CTRI/2026/03/107211 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
14/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between two solutions of anethesia for root canal treatment using computer controlled device. |
|
Scientific Title of Study
|
Comparative evaluation of anesthetic efficacy of 4% articaine with
1:100,000 adrenaline and 2% lignocaine with 1:80,000 adrenaline as
intraligamentary injection by using star pen after an ineffective inferior
alveolar nerve block in mandibular molars with acute irreversible
pulpitis of patient aged 18-50 years: A Randomised controlled 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 |
Shashikala Pande |
| Designation |
PG student |
| Affiliation |
MGVs KBH Dental College, Nashik |
| Address |
Department no 502, MGVs KBH Dental College, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9604671947 |
| Fax |
|
| Email |
shashikalapande11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swapnil Kolhe |
| Designation |
Professor |
| Affiliation |
MGVs KBH Dental College, Nashik |
| Address |
Department no 502, MGVs KBH Dental College, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822198233 |
| Fax |
|
| Email |
endoswapnil33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swapnil Kolhe |
| Designation |
Professor |
| Affiliation |
MGVs KBH Dental College, Nashik |
| Address |
Department no 502, MGVs KBH Dental College, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822198233 |
| Fax |
|
| Email |
endoswapnil33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department no 502, MGVs KBH Dental College, Nashik 42003, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
SHASHIKALA PANDE |
| Address |
Department no 502, MGVs KBH Dental College, Nashik 422003, Maharashtra, India
|
| 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 Shashikala Pande |
MGVs KBH DENTAL COLLEGE |
Department no 502, Department of conservative dentistry and endodontics.
Nashik
MAHARASHTRA |
9604671947
shashikalapande11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KBH DENTAL COLLEGE-INSTITUTIONAL ETHICS COMMITTEE |
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 |
articaine vs lignocaine |
4% articaine with
1:100,000 adrenaline vs 2% lignocaine with 1:80,000 adrenaline as
intraligamentary injection by using star pen in mandibular molars. |
| Intervention |
Using Star pen |
anesthesia by using star pen in intraligamentary site |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient having no systemic diseases
2)Patients between 18-50 years of age
3)Mandibular molars with a diagnosis of acute irreversible pulpitis. |
|
| ExclusionCriteria |
| Details |
1) Teeth with periodontal defects.
2) Patients with hypersensitivity to lidocaine and /or articaine.
3) Pregnancy or lactation.
4) Teeth with any periapical pathology.
5) Teeth with immature root apex.
6) Patient on any kind of medication example NSAIDS, sedatives,
antidepressants. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the intraoperative pain after ineffective inferior
alveolar nerve block administration by conventional method in
mandibular molars on visual analogue scale.
2. To evaluate the intraoperative pain after administration of 2%
lignocaine with 1:80,000 adrenaline as a supplementary
intraligamentary injection by using star pen on visual analogue
scale.
3. To evaluate the intraoperative pain after administration of 4%
articaine with 1:100,000 adrenaline as a supplementary
intraligamentary injection by using star pen on visual analogue
scale.
4. To compare the intraoperative pain after ineffective inferior
alveolar nerve block and after administration of 2% lignocaine
with 1:80,000 adrenaline and 4% articaine with 1:100,000
adrenaline as intraligamentary injection by using star pen. |
60-80 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
30/03/2026 |
| 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="3"
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
|
Sampling technique:
Simple random sampling technique will be used.
VI. Methods of selection of study subjects:
1.Inclusion criteria :
1)Patient having no systemic diseases
2)Patients between 18-50 years of age
3)Mandibular molars with a diagnosis of acute irreversible pulpitis.
2. Exclusion criteria:
1) Teeth with periodontal defects.
2) Patients with hypersensitivity to lidocaine and /or articaine.
3) Pregnancy or lactation.
4) Teeth with any periapical pathology.
5) Teeth with immature root apex.
6) Patient on any kind of medication example NSAIDS, sedatives,
antidepressants.
VII. Operational definitions:
A) Intraoperative pain:
Intraoperative pain is defined as the intensity of pain perceived by the
patient during endodontic treatment, specifically from the initiation of
access cavity preparation to completion of canal instrumentation.
B) Visual analog scale:
Pain levels will be recorded using a Visual Analog Scale (VAS)
immediately after the procedure, with scores ranging from 0 (no pain)
to 10 (worst imaginable pain), based on the patient’s subjective
experience during the treatment phase.
VIII. Method of measurements:
The visual analogue scale (VAS): The Visual Analogue Scale (VAS) is a 10
cm line with anchor statements on the left (no pain) and on the right
(extreme pain). The patient will be asked to mark their current pain level
on the line. They will be asked to mark their maximum, minimum, and
average pain. The examiner scores the VAS by measuring the distance in
either centimeters (0 to 10) or millimeters (0 to 100) from the “no pain”
anchor point.
IX. Study instrument/ Data collection tool: -
The visual analogue scale (VAS):
X. Method of Data collection: -
24 subjects with failed inferior alveolar nerve block will be choosen for
the study. A detailed medical history will be taken from each patient
followed by clinical examination. Radiographic examination will be done
to confirm. Patients will be informed about the details of study
procedure and informed consent form will be obtained from them.
Before administration of intraligamentary injection intraoperative pain
will be recorded from all subjects.
These subjects will be randomly divided into two groups of 12 samples
each.
Groups will be as follows:-
Group I: Administration of 2% lignocaine with 1:80000 adrenaline by
intraligamentary injection technique (n=12) using star pen.
GroupI II: Administration of 4% articaine with 1:100,000 adrenaline by
intraligamentary injection technique (n=12) using star pen.
Patient will be administered 1.8ml of either 2% lignocaine with 1:80000
adrenaline or 4% articaine with 1:100,000 adrenaline intraligamentary
using star pen.
After 5 mins of intraligamentary injections, access cavity preparation will
be prepared and canals will be located.
#10 K- file will be inserted in each canal. Working length will be
determined using apex locator. Then complete pulp extirpation will be
done followed by normal saline irrigation.
After this step intraoperative pain will be assessed on VAS and will be
noted down. |