| CTRI Number |
CTRI/2025/09/094137 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of a natural Clove-Chamomile gel and Lignocaine gel to reduce injection pain in children during dental treatment |
|
Scientific Title of Study
|
Comparative evaluation of Clove-Chamomile gel Vs Lignocaine gel as Topical Anaesthetic Prior to Local Anaesthesia in Children: A Randomized Clinical 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 |
Ganganapalli Reddy Sravya |
| Designation |
MDS 2nd year |
| Affiliation |
Narayana Dental College and Hospital, Nellore |
| Address |
Pediatric and Preventive Dentistry, Room number 7, Division 7, Narayana Dental College and Hospital, Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
07075432819 |
| Fax |
|
| Email |
grsravya98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. S.V.S.G Nirmala |
| Designation |
MDS Professor |
| Affiliation |
Narayana Dental College and Hospital, Nellore |
| Address |
Pediatric and Preventive Dentistry, Room number 7, Division 7, Narayana Dental College and Hospital, Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9440206976 |
| Fax |
|
| Email |
nimskrishna2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ganganapalli Reddy Sravya |
| Designation |
MDS 2nd year |
| Affiliation |
Narayana Dental College and Hospital, Nellore |
| Address |
Pediatric and Preventive Dentistry, Room number 7, Division 7, Narayana Dental College and Hospital, Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
07075432819 |
| Fax |
|
| Email |
grsravya98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Dental College and Hospital, Chinthareddypalem, Nellore, Andhrapradesh, India
Pincode : 524003 |
|
|
Primary Sponsor
|
| Name |
Ganganapalli Reddy Sravya |
| Address |
Narayana Dental College and Hospital, Chinthareddypalem, Nellore
Andhra Pradesh
India
Pincode:524003
|
| 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 |
| DrGanganapalli Reddy Sravya |
Narayana Dental College and Hospital, Nellore |
Pediatric and preventive dentistry Room number 7,Division 7,Narayana dental college and hospital, chinthareddypalem, Nellore,Andhrapradesh,India
Pincode :524003
Nellore
ANDHRA PRADESH |
07075432819
grsravya98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Dental College and Hospital, Nellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
“Children aged 8–12 years, willing to participate, requiring local anaesthesia for dental procedures, and without any cognitive disorders.”
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clove-Chamomile gel and Lignocaine gel |
Children in Group 1 will receive Clove-Chamomile Gel applied with a cotton applicator on the oral mucosa for 1 minute before local anaesthesia administration, while children in Group 2 will receive 2% Lignocaine gel applied in the same manner. |
| Comparator Agent |
There is Comparision between Clove-Chamomile gel and 2% Lignocaine gel |
Children in Group 1 will receive Clove-Chamomile gel applied with a cotton applicator on the oral mucosa for 1 minute before local anaesthesia administration, and children in Group 2 will receive 2% Lignocaine gel applied in the same manner. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
8-12 years old children
Children who are willing to participate in the study.
Children requiring LA for dental procedures
Children with no cognitive disorders
|
|
| ExclusionCriteria |
| Details |
Special health care need Children
Recent trauma to oral tissues
Children with a history of hypersensitivity reactions to any components present in the anaesthetic agents
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain perception during local anaesthesia administration, assessed using the Sound-Eye-Motor (SEM) scale (objective) and the Oucher pain scale (subjective). |
Pain perception is measured
During LA administration by SEM scale (objective) and
Immediately after LA administration by Oucher pain scale (subjective)
Time points: During LA administration (SEM); Immediately after LA administration (within 1 minute) (Oucher).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physiological response measured by pulse rate recorded with a pulse oximeter before, during, & after local anaesthesia administration. |
Pulse rate (physiological parameter) is measured
Before LA administration (baseline),
During LA administration and
Immediately after LA administration
Time points: Pulse rate will be measured before, during, & immediately after local anaesthesia administration. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 2 |
|
Date of First Enrollment (India)
|
03/10/2025 |
| 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="2"
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
|
This study will be conducted on 52 healthy children aged 8 to 12 years requiring local anaesthesia for dental procedures. The children will be randomly divided into two groups with 26 in each group. Group 1 will receive Clove-Chamomile gel and Group 2 will receive 2 percent Lignocaine gel applied topically on the oral mucosa for one minute before local anaesthesia administration. Pain perception will be assessed using the Sound Eye Motor scale during injection and the Oucher pain scale after injection. Pulse rate will also be recorded using a pulse oximeter before, during, and after the procedure to evaluate physiological response. |