| CTRI Number |
CTRI/2025/03/083417 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Alternative injection technique for endodontic therapy in children |
|
Scientific Title of Study
|
Comparative Evaluation of 4% articaine interdental injection and 2% lignocaine conventional inferior alveolar nerve block for inducing pulpal anaesthesia in lower mandibular molars - a split mouth randomised single blinded 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 |
Ayushma Chakravorty |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Pediatric and Preventive Dentistry, Clinic 28, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
8105571998 |
| Fax |
|
| Email |
152211001.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunny Priyatham Tirupathi |
| Designation |
Reader |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Pediatric and Preventive Dentistry, Clinic 28, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9490549454 |
| Fax |
|
| Email |
dr.priyatham@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunny Priyatham Tirupathi |
| Designation |
Reader |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Pediatric and Preventive Dentistry, Clinic 28, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India
TAMIL NADU
600077
India |
| Phone |
9490549454 |
| Fax |
|
| Email |
dr.priyatham@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self sponsored
Department of Pediatric and Preventive Dentistry, Clinic 28, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India |
|
|
Primary Sponsor
|
| Name |
Self sponsored |
| Address |
Conducted in Department of Pediatric and Preventive Dentistry, Clinic 28, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India |
| 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 |
| Dr Sunny Priyatham Tirupathi |
Saveetha Dental College and Hospitals |
Department of Pediatric and Preventive Dentistry, Clinic 28, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India
Chennai
TAMIL NADU |
9490549454
dr.priyatham@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Endodontic management of decayed mandibular molars in children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% lignocaine |
2% lignocaine delivered through a conventional inferior alveolar nerve block (IANB) for inducing pulpal anesthesia in primary mandibular molars |
| Intervention |
Interdental injection using 4% articaine
|
An interdental injection with 4% articaine using a fine gauze needle to administer it between the teeth ( in the interdental region ) to provide targeted pain relief. Articaine, a widely used amide-type local anesthetic, is preferred for its rapid onset and strong anesthetic effect. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children who require pulpectomy in mandibular primary molars. |
|
| ExclusionCriteria |
| Details |
Children with systemic disorders, presence of lesions on radiographs, any maxillofacial pain, such as temporomandibular disorder, and known or suspected allergies to lignocaine and articaine, root canal therapy, maxillary pulpectomy, pulpotomy, teeth indicated for extraction and children with special health care needs, and parents who did not given consent are all considered to be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulpal response after 3 mins , 5 mins using VAS scale and electric pulp tester
|
3 mins and 5 mins
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
operator evaluated flacc scale , heart rate physiologic parameter
|
3mins, 5mins |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 will compare the efficacy of 4% articaine administered via interdental injection with 2% lignocaine delivered through a conventional inferior alveolar nerve block (IANB) for inducing pulpal anesthesia in primary mandibular molars. Using a split-mouth, randomized, single-blinded design, participants received both interventions on different sides of the mandible, allowing direct intra-subject comparison. |