| CTRI Number |
CTRI/2025/03/082942 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison of anesthetic efficacy of Lidocaine, Prilocaine, and Articaine for Children’s Root canal Treatment in molars. |
|
Scientific Title of Study
|
Comparative anesthetic efficacy evaluation of 2 percent Lignocaine, 3 percent Prilocaine and 4 percent Articaine during pulpectomy in mandibular primary molars - A parallel randomized control trail. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raparla Siva Teja |
| Designation |
Post Graduate Student |
| Affiliation |
St. Joseph Dental College |
| Address |
Room No. 4,
Department Of Paediatric and Preventive Dentistry,
Block-1,
1st floor,
St. Joseph Dental College,
Duggirala,
Eluru,
Andhra Pradesh 534003,
India.
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
7288099666 |
| Fax |
|
| Email |
rsivateja27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. M. Ghana Shyam Prasad |
| Designation |
Professor |
| Affiliation |
St. Joseph Dental College |
| Address |
Room No. 4,
Department Of Paediatric and Preventive Dentistry,
Block-1,
1st floor,
St. Joseph Dental College,
Duggirala,
Eluru,
Andhra Pradesh 534003,
India.
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9848585559 |
| Fax |
|
| Email |
drghanasyam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raparla Siva Teja |
| Designation |
Post Graduate Student |
| Affiliation |
St. Joseph Dental College |
| Address |
Room No. 4,
Department Of Paediatric and Preventive Dentistry,
Block-1,
1st floor,
St. Joseph Dental College,
Duggirala,
Eluru,
Andhra Pradesh 534003,
India.
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
7288099666 |
| Fax |
|
| Email |
rsivateja27@gmail.com |
|
|
Source of Monetary or Material Support
|
| St. Joseph Dental College,
Duggirala,
Eluru,
Andhra Pradesh 534003,
India.
|
|
|
Primary Sponsor
|
| Name |
St Joseph Dental College |
| Address |
Room No. 4, Block-1, 1st floor, St Joseph Dental College, Duggirala, Eluru, Andhra Pradesh, 534003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Raparla Siva Teja |
St. Joseph Dental College |
Room No. 4,
Department Of Paediatric and Preventive Dentistry,
Block-1,
1st floor,
St. Joseph Dental College,
Duggirala,
Eluru,
Andhra Pradesh 534003,
India.
West Godavari
ANDHRA PRADESH |
7288099666
rsivateja27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SJDC-Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
children indicated for pulpectomy in primary mandibular molars |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Articaine Hydrochloride 4 Percent + Epinephrine 1:100000 |
1.0 ml via Infiltration Administered at a rate of 1ml/min |
| Comparator Agent |
Articaine Hydrochloride 4 Percent + Epinephrine 1:100000 |
1.8 ml via Inferior Alveolar Nerve Block Administered at a rate of 1ml/min |
| Comparator Agent |
Lidocaine Hydrochloride 2 Percent + Adrenaline 1:80000 |
1.8 ml via Inferior Alveolar Nerve Block Administered at a rate Of 1ml/min |
| Intervention |
Local Anesthesia |
Inferior Alveolar Nerve Block or Infiltration for Pulpectomy in Primary Mandibular Molars |
| Comparator Agent |
Prilocaine Hydrochloride 3 Percent + Felypressin 0.013IU/ml |
1.8 ml via Inferior Alveolar Nerve Block Administered at a rate of 1ml/min |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Healthy normal children ofAge group of5-12 years.
Children requiring pulpectomy for primary mandibular molars. |
|
| ExclusionCriteria |
| Details |
Children whose parents/caregiver did not give the consent for the study.
Children with underlying systemic diseases.
Children with history of adverse reactions to anesthetic agents.
Children under medications that have adverse reactions to anesthetic agents.
Children with infection near injection site. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset of anesthesia (evaluated using subjective and objective methods) |
immediately after administration (ranges from seconds to minutes) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| duration of anesthesic action (evaluated using subjective & objective methods) |
baseline (from onset to 4 hrs) |
| postoperative complications (identified using questionnaire) |
24 hours post-treatment |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "121"
Final Enrollment numbers achieved (India)="121" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2025 |
| Date of Study Completion (India) |
25/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - For any queries and data access, the requestors can contact to
"rsivateja27@gmail.com"
- For how long will this data be available start date provided 29-03-2025 and end date provided 28-03-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Pain during dental procedures is a significant source of fear and anxiety in children hence this study investigates the effectiveness of different local anaesthetics like 2 percent lignocaine, 3 percent prilocaine and 4 percent articaine in managing dental pain in children undergoing pulpectomy for primary mandibular molars. The study compares the onset, duration, intraoperative pain, postoperative pain, and complications of these anaesthetics when administered via inferior alveolar nerve block (IANB) versus 4% articaine via infiltration in children aged 5–12 years. |