| CTRI Number |
CTRI/2024/02/062630 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
efficacy of lemongrass oil in reducing dental anxiety in children |
|
Scientific Title of Study
|
Clinical efficacy of Lemongrass oil in reducing the anxiety of children during Dental procedures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NILIMA THOSAR |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, SAWANGI , WARDHA, MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422163632 |
| Fax |
|
| Email |
drnthosar@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AAKRITI CHANDRA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, SAWANGI , WARDHA, MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
7903633717 |
| Fax |
|
| Email |
aakritich.smile@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AAKRITI CHANDRA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, SAWANGI , WARDHA, MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
7903633717 |
| Fax |
|
| Email |
aakritich.smile@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL, |
|
|
Primary Sponsor
|
| Name |
SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL |
| Address |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH , SAWANGI MEGHE, WARDHA, MAHARASHTRA-INDIA |
| 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 |
| AAKRITI CHANDRA |
SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY,SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, SAWANGI MEGHE, WARDHA, MAHARASHTRA
Wardha
MAHARASHTRA |
7903633717
aakritich.smile@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION & RESEARCH [DEEMED TO BE UNIVERSITY], INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ANXIOUS CHILDREN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lavender oil |
Two drops of essential oil in a diffuser and kept in a room for 45 min to see its effect in reducing anxiety |
| Intervention |
Lemongrass oil |
Two drops of essential oil in a diffuser and kept in a room for 45 min to see its effect in reducing anxiety of children |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of age range from 6 to 12 years
2. Healthy and psychologically sound Children
3. Children reporting for their 1st dental visit
|
|
| ExclusionCriteria |
| Details |
1. Children with history of anxiety associated with LA
2. Children affected with trauma
3. Children having systemic problems
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| for subjective assessment -venham picture scale wiLl be used for lemongrass oil against lavender oil in reducing dental anxiety of patient |
BEFORE,DURING AND AFTER THE DENTAL PROCEDURE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| for objective assessment- pulse oxymeter will used to measure & compare heart rate & oxygen saturation leve |
before, during AND after of dental procedure |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
23/02/2024 |
| 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="6"
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
|
One of the most prevalent issues that dentists deal with is dental anxiety, particularly in pediatric patients. Children can be soothed by using essential oils and aromatherapy. The study aims to assess the efficacy of essential oils such as lemongrass and lavender in lowering dental anxiety in pediatric patients undergoing dental operations. 34 kids between the ages of 6 and 12 will be involved in the study. Lavender (the control group) and Lemongrass (the experimental group) were randomly assigned to the groups. All patients will have their dental anxiety psychometrically assessed using the "Venham’s picture test." In addition, a pulse oxymeter will be used as a biological marker in the study to measure oxygen saturation and pulse rate. When used in aromatherapy, lemongrass essential oil will lessen young patients’ anxiety during dental treatments more effectively than lavender oil. |