| CTRI Number |
CTRI/2025/08/093134 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of efficacy, hemodynamic changes, and postoperative complications of 2% lidocaine using inferior alveolar nerve block and 4% articaine using intraosseous anaesthesia in mandibular primary molars of children aged 6 to 8 years: An in vivo, randomized, controlled study |
|
Scientific Title of Study
|
Comparative evaluation of efficacy, hemodynamic changes, and postoperative complications of 2 percent lidocaine using inferior alveolar nerve block and 4 percent articaine using intraosseous anaesthesia in mandibular primary molars of children aged 6 to 8 years: An in vivo, randomized, controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hinal Kanabar |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College And Hospital |
| Address |
Pacific Dental College And Hospital Debari Udaipur Pacific Dental College And Hospital Debari Udaipur Udaipur RAJASTHAN 313024 India |
| Phone |
09265289652 |
| Fax |
|
| Email |
heenalkanabar123@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dinesh Rao |
| Designation |
HOD PG guide |
| Affiliation |
Pacific Dental College And Hospital |
| Address |
Department of pediatric and preventive dentistry Pacific Dental College And Hospital Debari Udaipur Pacific Dental College And Hospital Debari Udaipur Udaipur RAJASTHAN 313024 India |
| Phone |
09265289652 |
| Fax |
|
| Email |
pedodinesh2003@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Hinal Kanabar |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College And Hospital |
| Address |
Department of pediatric and preventive dentistry Pacific Dental College And Hospital Debari Udaipur Pacific Dental College And Hospital Debari Udaipur Udaipur RAJASTHAN 313024 India |
| Phone |
09265289652 |
| Fax |
|
| Email |
heenalkanabar123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific Dental College and Hospital Debari Udaipur 313024 |
|
|
Primary Sponsor
|
| Name |
Hinal Kanabar |
| Address |
Pacific Dental College And Hospital Debari Udaipur 313024 |
| 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 |
| DrHinal Kanabar |
Pacific Dental College And Hospital Debari Udaipur 313024 |
Department of pediatric
and preventive dentistry
first floor room number
nine Pacific Dental
College And Hospital
Debari Udaipur 313024
Udaipur
RAJASTHAN Udaipur RAJASTHAN |
9265289652
heenalkanabar123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee Sai Tirupati University Udaipur Rajasthan India |
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 |
Inferior alveolar nerve block |
Injecting 2% lidocaine in primary mandibular molars that require pulp therapy duration of anesthesia pain during procedures and pstoperative complications within 24 hours |
| Comparator Agent |
Intraosseous anaesthesia |
Injecting 4% Articaine in primary mandibular molars that require pulp therapy and it will be assessed duration of anesthesia pain during procedures and pstoperative complications within 24 hours |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Aged 6-8 years
Medically fit children
Mentally capable of communication
Having mandibular primary molar tooth that require pulp therapy
Tooth without having any kind of history of infection (abscess) or swelling and no evidence of periapical pathosis or soft tissue infection/inflammation near the site of injection.
Children, who are cooperative enough to undergo dental procedures and parental informed written consent provided.
Tooth, which will give a baseline reading on pulp tester before administration of local anaesthetics.
|
|
| ExclusionCriteria |
| Details |
Medically and mentally compromised children.
History of significant behaviour management problems.
Evidence of infection near the proposed injection site as this might affect the efficacy of local anaesthesia like periodontal (periodontal pockets or tooth mobility), radiological alterations (bone loss or periapical radio transparencies).
Children who did not speak or understand local language.
Children who are allergic to 4% articaine.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intraosseous Anaesthesia using 4% articaine with needle guide system shows:
Faster onset of action in mins
Better pain control during procedures using WBFS, VAS and SEM scale
|
Evaluation will be done at the baseline and one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraosseous Anaesthesia using 4% articaine with needle guide system showed:
Minimal hemodynamic changes like increase in heart rate
Lower incidence of postoperative complications like soft tissue injuries within 24 hours
|
Evaluation will be done at the baseline & one week |
|
|
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)
|
29/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" 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
|
Effective
pain management is crucial in pediatric dentistry to ensure a positive
experience for young patients. The inferior alveolar nerve block (IANB) is
commonly used to anesthetize mandibular teeth but has a notable failure rate,
especially in children, due to anatomical variations and technical challenges.
Studies indicate that IANB can fail in approximately 30% to 45% of cases, even
when proper techniques are employed.
Intraosseous
anesthesia (IOA) presents an alternative, involving the direct injection of
anesthetic into the cancellous bone, potentially offering more reliable
anesthesia for mandibular procedures. Recent advancements, such as the
TuttleNumbNow (TNN) system, utilize specialized needles to facilitate this
technique. Comparative studies have explored the efficacy of 4% articaine
versus 2% lidocaine in pediatric patients. Some findings suggest that articaine
may provide superior anesthetic success rates and faster onset compared to
lidocaine.
However,
very few studies have found no significant difference in efficacy between the
two anesthetics when used for primary molar extractions in children. The
proposed research aims to further evaluate these findings by comparing the
efficacy, hemodynamic responses, and postoperative complications of 2%
lidocaine via IANB and 4% articaine via IOA in children aged 6–8 undergoing
mandibular primary molar procedures. The outcomes could inform best practices
in pediatric dental anesthesia, potentially leading to improved patient comfort
and treatment outcomes. |