| CTRI Number |
CTRI/2025/09/095420 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Making Palatal Anesthesia More Comfortable for Children: Using EMLA Cream with Different Drug Delivery Methods |
|
Scientific Title of Study
|
Optimizing Palatal Anesthesia in Children: EMLA Cream with Different Drug Delivery Systems |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRAGYA |
| Designation |
PG STUDENT |
| Affiliation |
PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTER, BHOPAL |
| Address |
ROOM NO. S9, DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTER, BHANPUR, BHOPAL
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9304535387 |
| Fax |
|
| Email |
pragya.31.pandey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PARIMALA KULKARNI |
| Designation |
DEAN AND HOD |
| Affiliation |
PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTER, BHOPAL |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY,PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTER, BHANPUR, BHOPAL
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9425453853 |
| Fax |
|
| Email |
drtyagip@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRAGYA |
| Designation |
PG STUDENT |
| Affiliation |
PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTER, BHOPAL |
| Address |
ROOM NO. S9, DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTER, BHANPUR, BHOPAL
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9304535387 |
| Fax |
|
| Email |
pragya.31.pandey@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTER |
| Address |
PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTER, BHANPUR, BHOPAL, INDIA,462037 |
| 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 Pragya |
Peoples college of dental sciences and research center |
Room no.S9, Department of Pediatric and preventive Dentistry,Peoples college of Dental sciences and research center,Bhanpur, Bhopal,462037
Bhopal
MADHYA PRADESH |
9304535387
pragya.31.pandey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC OF PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children indicated for extraction of teeth |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
EMLA CREAM |
Efficacy of EMLA cream alone as a topical anesthetic for palatal infiltration for extraction procedure |
| Intervention |
EMLA with physical and chemical barrier |
To evaluate the efficacy of EMLA cream as topical anesthetic for palatal infiltration combined with physical and chemical barrier which increases its permeability |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 6-14 years.
2. Upper primary teeth indicated for extraction.
3. Not received any pain medication in last 3 hours before the procedure.
4. Never had a negative dental experience.
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised and mentally challenged patients.
2. Allergic to anesthetic drugs.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain perception during palatal anesthesia measured by:
Wong-Baker Faces Pain Scale
FLACC (Face, Legs, Activity, Cry, Consolability) Scale
at two stages:
During palatal probing
During the tooth extraction procedure |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparative efficacy of the three delivery methods (EMLA alone, EMLA with microneedle patches, EMLA with propylene glycol) in reducing pain.
Overall comfort & acceptability of the intervention for children (based on behavioral & observational pain responses). |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
04/10/2027 |
| 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 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 study titled “Optimizing Palatal Anesthesia in Children: EMLA Cream with Different Drug Delivery Systems” aims to improve pain control during pediatric dental procedures. Since conventional topical anesthetics are less effective on the keratinized palatal mucosa, EMLA cream is explored for its ability to enhance anesthesia. The trial involves 36 children randomly divided into three groups: EMLA alone, EMLA with microneedle patches, and EMLA with propylene glycol. Pain perception will be assessed at two points—during palatal probing and tooth extraction—using the Wong-Baker Faces Pain Scale and FLACC scale. The study seeks to determine which drug delivery method provides the most effective and comfortable palatal anesthesia in children. |