| CTRI Number |
CTRI/2025/10/095699 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
This study checks which numbing injection works best for dental treatment of the tooth nerve (vital pulp therapy) — Articaine, Bupivacaine, or Lidocaine |
|
Scientific Title of Study
|
Assessment of anesthetic efficacy of Buccal infiltration with 4 percent Artcaine , 0.5 percent Bupivacaine and 2 percent Lidocaine Inferior Alveolar Nerve Block in Vital Pulp Therapy A Randomized 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 |
Dr Hetal Joshi |
| Designation |
post graduate student mds first year |
| Affiliation |
JMFS ACPM DENTAL COLLEGE SAKRI ROAD DHULE |
| Address |
Department number 5 building number 2 Department of pediatric s and preventive dentistry JMFS ACPM Dental College and Hospital Sakri Road Dhule 424001
Department number 5 building number 2 Department of pediatric s and preventive dentistry JMFS ACPM Dental College and Hospital Sakri Road Dhule 424001
Dhule
MAHARASHTRA
424001
India |
| Phone |
8888331856 |
| Fax |
|
| Email |
hetal.joshi317@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandesh Bansal |
| Designation |
Reader |
| Affiliation |
JMFS ACPM DENTAL COLLEGE SAKRI ROAD DHULE |
| Address |
Department number 5 building number 2 Department of pediatric s and preventive dentistry JMFS ACPM Dental College and Hospital Sakri Road Dhule 424001
Department number 5 building number 2 Department of pediatric s and preventive dentistry JMFS ACPM Dental College and Hospital Sakri Road Dhule 424001
Dhule
MAHARASHTRA
424001
India |
| Phone |
9689141996 |
| Fax |
|
| Email |
sandesh.bansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hetal Joshi |
| Designation |
post graduate student mds first year |
| Affiliation |
JMFS ACPM DENTAL COLLEGE SAKRI ROAD DHULE |
| Address |
Department number 5 building number 2 Department of pediatric s and preventive dentistry JMFS ACPM Dental College and Hospital Sakri Road Dhule 424001
Department number 5 building number 2 Department of pediatric s and preventive dentistry JMFS ACPM Dental College and Hospital Sakri Road Dhule 424001
Dhule
MAHARASHTRA
424001
India |
| Phone |
8888331856 |
| Fax |
|
| Email |
hetal.joshi317@gmail.com |
|
|
Source of Monetary or Material Support
|
| JMFS ACPM DENTAL COLLEGE SAKRI ROAD DHULE MAHARASHTRA INDIA 424001 |
|
|
Primary Sponsor
|
| Name |
Dr Hetal Joshi |
| Address |
Department number 5 building number 2 Department of pediatric s and preventive dentistry JMFS ACPM Dental College and Hospital Sakri Road Dhule 424001 |
| 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 Hetal Joshi |
JMFS ACPM Dental College and Hospital |
Department number 5 building number 2 Department of pediatric s and preventive dentistry JMFS ACPM Dental College and Hospital Sakri Road Dhule 424001
Dhule
MAHARASHTRA |
8888331856
hetal.joshi317@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF JMFS ACPM DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 percent lidocaine |
1.8 ml of 2 percent lidocaine inferior alveolar nerve block . the study will be conducted at single visit appointment of patient for 30 mins. |
| Intervention |
4 percent Articaine
0.5 percent bupivacaine |
buccal infiltration with 0.8 ml of 4 percent articaine and 0.8 ml of 0.5 percent bupivacaine in vital pulp therapy. Study will be conducted at single visit appointment of patient for 30 mins. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1)Permanent first and second mandibular molars indicated for vital pulp therapy will be selected based on clinical and radiographic screening.
2)Hot tooth
3)Age group 12-16 years
4)Pulp involved vital tooth
5)ASA I
|
|
| ExclusionCriteria |
| Details |
1)Teeth with abscess , fistula, With swelling
2)RC treated
3)Periapical lesion
4)Furcation involved
5)Patient allergic to LA
6)Systemically compromised and patients with history of drug allergy ASA II ASA III
7)Children / Guardian who are not willing
|
|
|
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 Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is satisfactory anesthetic efficacy with 4% Articaine , 0.5% Bupivacaine and IANB with 2% lignocaine |
Pain is evaluated peroperative before starting procedure by patient heft parker visual analog scale HP VAS , during treatment Sound eye motor SEM will be recorded on caries excavation reaching deep dentine and /or pulp , after completion of procedure patient will be asked to record facial image scale ,heft parker visual analog scale study will be conducted in single visit appointment of patient assessment will be done intraoperatively and Postoperatively within one hour of time period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post operative complication at site of injection |
after 24 hours through telephonic communication |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/10/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
The study compares the anesthetic efficacy of 4 percent articaine and 0 point 5 percent bupivacaine buccal infiltration with 2 percent lidocaine inferior alveolar nerve block in children aged 12 to 16 years requiring vital pulp therapy. Ninety children were randomly divided into three groups. Pain was assessed using heft parker visual analog scale pre operatively and post operatively ,sound eye motor scores will be record during treatment and facial image scale post operatively . Post operative complications will be record after 24 hours at site of injection . The aim is to compare and evaluate 3 different local anesthtic is better for pain control in pediatric dentistry. |