| CTRI Number |
CTRI/2025/02/080759 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of needless injector for local anesthesia for pediatric dental procedure |
|
Scientific Title of Study
|
Efficacy and pain perception of a needleless Local Anesthesia delivery system for palatal anesthesia in pediatric dental patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonal Mali |
| Designation |
Post graduate student |
| Affiliation |
D.Y. Patil University School of Dentistry |
| Address |
D.Y.Patil university school of dentistry, sector 7, nerul navimumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9969950552 |
| Fax |
|
| Email |
dr.sonalmali97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa S Naik |
| Designation |
Head of Department of Pediatric and Preventive Dentistry |
| Affiliation |
D.Y. Patil University School of Dentistry |
| Address |
D.Y.Patil university school of dentistry, sector 7, nerul navimumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9769600440 |
| Fax |
|
| Email |
shilpa.naik@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa S Naik |
| Designation |
Head of Department of Pediatric and Preventive Dentistry |
| Affiliation |
D.Y. Patil University School of Dentistry |
| Address |
D.Y.Patil university school of dentistry, sector 7, nerul navimumbai
MAHARASHTRA
400706
India |
| Phone |
9769600440 |
| Fax |
|
| Email |
shilpa.naik@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| D.Y.Patil university school of dentistry, Sector 7, Nerul, Navimumbai, Maharashtra India 400706 |
|
|
Primary Sponsor
|
| Name |
D Y Patil University school of dentistry Navimumbai |
| Address |
D.Y.Patil university school of dentistry, Sector 7, Nerul, Navimumbai, Maharashtra India 400706 |
| Type of Sponsor |
Private medical college |
|
|
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 Shilpa S Naik |
D.Y. Patil University School of Dentistry |
Department of pediatric and preventive dentistry, Basement, D.Y.Patil university school of dentistry, sector 7, nerul navimumbai
Thane
MAHARASHTRA |
9769600440
shilpa.naik@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional research and ethical board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control |
LA buccal and palatal infiltration will be administered using the conventional needle and syringe |
| Intervention |
Local anesthesia using needless jet injector Comfort IN |
Local Anesthesia (2% lignocaine with 1:80000 adrenaline) buccal and palatal infiltration will be administered using the needleless device Comfort-in™ system. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 Classification
Children of 4-9 years of age
Children of those parents willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Children whose parents do not give consent
Children who are allergic to local anesthetic solution and its constituents |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain perception and efficacy of local anesthesia using comfort in injector device |
baseline, during local anesthesia, during treatment, after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time taken for LA administration, dental anxiety |
baseline, during treatment & after treatment |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
27/02/2025 |
| 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="1"
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
|
Aim: To evaluate the
pain perception and efficacy of a needleless LA delivery system.
Materials and
methods: 64
children aged 4-9 years, who need buccal and palatal infiltration for extractions
will be included in the study. By simple randomized sampling they will be
assigned to two research groups; Group A (Control group), Group B
(Interventional group). Pulse rate, FBRS, Wong Bakers FACES pain rating scale
and Modified Behaviour rating scale by Taddio et al will be used to assess pain
perception and efficacy. Group A: LA buccal and palatal infiltration will
be administered using regular disposable needle and syringe. Group B: LA
buccal and palatal infiltration will be administered using the needleless
device. |