| CTRI Number |
CTRI/2025/04/083992 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparative evaluation of clinical efficiency of two different block technique in pediatric dental patients |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical Efficiency of Direct Inferior Alveolar Nerve Block Technique Versus Fischer 123 Technique in Pediatric Dental Patients: A split mouth 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 |
Harsh Sanjaykumar Baldawa |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College Chennai Tamil nadu 600077 India
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College Chennai Tamil nadu 600077 India
Chennai
TAMIL NADU
600077
India |
| Phone |
8485841420 |
| Fax |
|
| Email |
baldawaharsh.hb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dinesh Kumar |
| Designation |
Senior Lecturer |
| Affiliation |
Saveetha Dental College and Hospital, SIMATS University |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College Chennai Tamil nadu 600077 India
Chennai
TAMIL NADU
600077
India |
| Phone |
8485841420 |
| Fax |
|
| Email |
dineshkumarb.sdc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harsh Sanjaykumar Baldawa |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College Chennai Tamil nadu 600077 India
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College Chennai Tamil nadu 600077 India
Chennai
TAMIL NADU
600077
India |
| Phone |
8485841420 |
| Fax |
|
| Email |
baldawaharsh.hb@gmail.com |
|
|
Source of Monetary or Material Support
|
| saveetha dental college and hospital, chennai |
|
|
Primary Sponsor
|
| Name |
Harsh Sanjaykumar Baldawa |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital Chennai Tamil nadu 600077 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 Dinesh Kumar |
Saveetha Dental College and Hospital |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital Chennai Tamil nadu 600077 India
Chennai
Chennai
TAMIL NADU |
9952007702
dineshkumarb.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| saveetha Dental College - Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (3) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
direct inferior alveolar nerve block |
1 minute, 2.5ml of lignocaine related to inferior alveolar nerve block |
| Intervention |
fischer 123 injection technique |
1 minute, 2.5ml of lignocaine related to inferior alveolar nerve block |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
7-11 years
mandibular molars advised for extraction
ASA I or II (healthy or mild systemic disease)
Written parental consent and child assent
Moderate anxiety and ability to follow instructions
Not on medications interfering with anesthesia |
|
| ExclusionCriteria |
| Details |
grade 3 mobile teeth
Childre with severe anxiety or uncooperative behavior requiring sedation or general anesthesia.
Children with prior adverse reactions to dental local anesthesia techniques.
Presence of acute orofacial infections or abscesses in the treatment area.
Children with significant developmental delays or neurological conditions affecting cooperation or pain perception.
Patients on medications interfering with local anesthesia efficacy or safety (e.g., anticoagulants, certain antidepressants). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain perception |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anxiety |
baseline |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 |
|
Date of First Enrollment (India)
|
08/04/2025 |
| 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="0"
Days="7" |
|
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
|
the comparative evaluation of the clinical efficiency of the direct inferior alveolar nerve (IAN) block technique versus the Fischer 123 technique in pediatric dental patients primarily aims to assess which method provides better anesthesia, comfort, and ease of administration for young patients. please note this is not my PG thesis. |