| CTRI Number |
CTRI/2026/03/106440 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [NIL] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Needle and Needle-Free Methods for Giving Palatal Anesthesia in Children Aged 4–9 Years. |
|
Scientific Title of Study
|
COMPARATIVE ASSESSMENT OF PAIN PERCEPTION, ANXIETY, COMFORT AND EFFECTIVENESS BETWEEN NEEDLE AND NEEDLE LESS DEVICES DURING THE ADMINISTRATION OF PALATAL BLOCK FOR DIFFERENT DENTAL PROCEDURES IN CHILDREN AGED 4-9 YEARS. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shibani Tudu |
| Designation |
Pg Trainee |
| Affiliation |
SCB dental college and hospital,Cuttack |
| Address |
Department of Pediatric and Preventive Dentistry,SCB dental college and Hospital,Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
8114969367 |
| Fax |
|
| Email |
shibangitudu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ratna Renu Baliarsingh |
| Designation |
Professor and HOD |
| Affiliation |
SCB dental college and hospital,Cuttack |
| Address |
Department of Pediatric and Preventive Dentistry,SCB dental college and Hospital,Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9437143994 |
| Fax |
|
| Email |
drrrbaliarsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shibani Tudu |
| Designation |
Pg Trainee |
| Affiliation |
SCB dental college and hospital,Cuttack |
| Address |
Department of Pediatric and Preventive Dentistry,SCB dental college and Hospital,Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
8114969369 |
| Fax |
|
| Email |
shibangitudu@gmail.com |
|
|
Source of Monetary or Material Support
|
| SCB Dental College and Hospital,Cuttack, Odisha 753007 |
|
|
Primary Sponsor
|
| Name |
Shibani Tudu |
| Address |
Department of Pediatric and Preventive Dentistry, SCB Dental College and Hospital, Cuttack |
| 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 |
| Shibani Tudu |
SCB Dental College and Hospital , Cuttack, Odisha |
PG Department of Pediatric and Preventive Dentistry
Cuttack
ORISSA |
08114969369
shibangitudu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A499||Bacterial infection, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INJEX 30 |
The palatal block was administered using the INJEX 30 where 0.05–0.3 mL of 2% lidocaine with 1:80,000 epinephrine was delivered. |
| Comparator Agent |
SlowJec CCLAD device |
A Lignospan cartridge was loaded into the SlowJec CCLAD device, and a conventional palatal nerve block was administered. After negative aspiration, 0.3–0.5 ml of 2% lidocaine with 1:80,000 epinephrine was deposited palatally. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children requiring palatal infiltration during dental procedures,Children belonging to the age group of 4-9 years,Children displaying Frankl behaviour ratings 3 and 4,Children who had never been administered a palatal infiltration.
|
|
| ExclusionCriteria |
| Details |
a.Children with learning and audio-visual impairment.
b.Children with any underlying systemic diseases.
c.Children with a pacemaker.
d.Children who are allergic to local anesthetic agents.
e. Children whose parents are not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain perception via the WONG-BAKER Faces Pain Rating Scale
2.Evaluation of anxiety using the Modified Child Dental Anxiety Scale |
Before and After LA administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Heart rate
2.Behavioural response using SEM Scale |
1.Before and after LA Administration
2.During LA Administration |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This parallel-group randomized controlled clinical trial will be conducted at SCB Dental College and Hospital, Cuttack, to compare and evaluate pain perception, anxiety level, comfort, and anesthetic effectiveness between needle-based (SlowJec CCLAD) and needle-free (INJEX 30) devices during the administration of palatal block for various dental procedures in children aged 4–9 years. Eligible children exhibiting Frankl behaviour ratings of 3 and 4 and with no prior history of palatal block will be randomly allocated into two groups. Pain perception will be assessed subjectively using the Wong–Baker Faces Pain Rating Scale, while anxiety will be evaluated using the Modified Child Dental Anxiety Scale (MCDAS). Objective parameters will include heart rate monitoring and behavioral responses assessed using the Sound-Eye-Motor (SEM) scale.
|