| CTRI Number |
CTRI/2025/07/091768 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of lidocaine gel and lidocaine ice button as topical anaesthetic for greater palatine nerve block |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of lidocaine gel and lidocaine ice button as topical anaesthetic for greater palatine nerve block in children aged 6-10 years : A randomized 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 |
Shruti Dawale |
| Designation |
Postgraduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Department of Pediatric and Preventive Dentistry,Ranjeet Deshmukh Dental College formerly called VSPM Dental College ,Digdoh Hills Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9545656015 |
| Fax |
|
| Email |
shrutidawale123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Nagpal |
| Designation |
H.O.D,Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Department of Pediatric and Preventive Dentistry,Ranjeet Deshmukh Dental College formerly called VSPM Dental College ,Digdoh Hills Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9764271839 |
| Fax |
|
| Email |
drdevendra19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devendra Nagpal |
| Designation |
H.O.D,Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Department of Pediatric and Preventive Dentistry,Ranjeet Deshmukh Dental College formerly called VSPM Dental College ,Digdoh Hills Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9764271839 |
| Fax |
|
| Email |
drdevendra19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre, Nagpur,Maharashtra 440019 |
|
|
Primary Sponsor
|
| Name |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur,Maharashtra 440019 |
| 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 |
| DrShruti Dawale |
Ranjeet Deshmukh Dental College and Research Centre |
Deapartment of pediatric and preventive dentistry, 3rd floor
Nagpur
MAHARASHTRA |
9545656015
shrutidawale123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RDDC&RCIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children aged 6-10 years old who are indicated for greater palatine nerve block for dental treatment.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
lidocaine gel |
lidocaine gel will be used as topical anaesthesia for greater palatine nerve block |
| Intervention |
lidocaine ice button |
lidocaine ice button will be used as topical anaesthesia for greater palatine nerve block for 1 min |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children indicated for dental procedure requiring a greater palatine nerve block.
Children who exhibited Frankl’s behaviour rating three or four
|
|
| ExclusionCriteria |
| Details |
Active infection at the site of injection
History of hospitalization/ surgery and those with chronic illness
Children with known history to allergy to any topical or local anaesthetic agent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare pain perception of children aged 6-10 years by using lidocaine gel and lidocaine ice button as topical anaesthetic for greater palatine nerve block via Wong Bakers FACES Scale and Sound Eye Motor Scale. |
baseline, after 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the acceptance of lidocaine ice button in children of aged 6-10 years. |
immediately after procedure |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
14/08/2025 |
| 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="1"
Months="8"
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 study aim to evaluate and compare pain perception of children aged 6-10 years by using lidocaine gel and lidocaine ice button as topical anaesthetic for greater palatine nerve block via Wong Bakers FACES
Scale and Sound Eye Motor Scale.Also to evaluate the acceptance of lidocaine ice button amongst children. |