| CTRI Number |
CTRI/2025/04/085344 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of aromatherapy with Ylang Ylang essential oil on dental anxiety and pain management in pediatric patients during local anaesthesia procedure. |
|
Scientific Title of Study
|
Effect of aromatherapy with Ylang Ylang essential oil on dental anxiety and pain in children during local anaesthesia procedure : A Randomised 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 |
DrBareera Iram |
| Designation |
PG Student |
| Affiliation |
Teerthanker Mahaveer Dental College And Research Centre, Moradabad |
| Address |
Room no. 617, 5th floor, Department Of Pedodontics And Preventive Dentistry, Teerthanker Mahaveer Dental College And Research Centre, Moradabad Moradabad UTTAR PRADESH 244001 India
Department Of Pedodontics And Preventive Dentistry, Teerthanker Mahaveer university,Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8979616853 |
| Fax |
|
| Email |
123bareerairam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kapil Dev Gupta |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Dental College And Research Centre, Moradabad , 244001 |
| Address |
Room no. 617, 5th floor, Department Of Pedodontics And Preventive Dentistry, Teerthanker Mahaveer Dental College And Research Centre, Moradabad Moradabad UTTAR PRADESH 244001 India.
Department Of Pedodontics And Preventive Dentistry, Teerthanker Mahaveer university, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9456914922 |
| Fax |
|
| Email |
kapil.dental@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DrBareera Iram |
| Designation |
PG Student |
| Affiliation |
Teerthanker Mahaveer Dental College And Research Centre, Moradabad |
| Address |
Room no. 617, 5th floor, Department Of Pedodontics And Preventive Dentistry, Teerthanker Mahaveer Dental College And Research Centre, Moradabad Moradabad UTTAR PRADESH 244001 India
Department Of Pedodontics And Preventive Dentistry, Teerthanker Mahaveer university, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8979616853 |
| Fax |
|
| Email |
123bareerairam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 617, 5th floor, Department Of Pedodontics And Preventive Dentistry, Teerthanker Mahaveer Dental College And Research Centre, Moradabad Moradabad UTTAR PRADESH 244001 India |
|
|
Primary Sponsor
|
| Name |
Dr BAREERA IRAM |
| Address |
Room No. 617, 5th Floor, Department Of Pedodontics And preventive Dentistry, Teerthanker Mahaveer Dental College And Research Centre, Moradabad, 244001, Uttar Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
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 Bareera Iram |
Teerthanker Mahaveer Dental College And Research Centre, Moradabad, Uttar Prades |
Room No 617, 5th Floor, Department Of Pedodontics and Preventive Dentistry, Teerthanker Mahaveer Dental College And Research Centre, Moradabad, 244001, Uttar Pradesh
Moradabad
UTTAR PRADESH |
8979616853
123bareerairam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Teerthanker Mahaveer Dental College and Research Centre,Moradabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Distilled water |
In this intervention distilled water is used as placebo. it will be completed in 3 months |
| Intervention |
Ylang Ylang essential oil |
ylang ylang is a yellow star shaped flower that grows on the cananga tree. There are some possible benefits of ylang ylang including pain relief, anxiety, fighting bacteria. It can be inhaled as an aroma therapy treatment. it will be completed in 3 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient aged 6-9 years requiring L.A administration in maxilla/mandible for pulp therapies/ extraction of teeth.2)Children with a score of more than or equal to 12 on modified child dental anxiety scale (MCDAS)
3)Patient with significant good physical and mental health.
4. Patient with normal BMI range |
|
| ExclusionCriteria |
| Details |
Children outside the age range of 6 to 12 years.
Children with significant cognitive impairments or behavioral disorders that may interfere with the study or the procedure. |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome is reduction of pain perception and anxiety levels in both the groups.
|
Measured at baseline and 5 min after procedure.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physiological parameter like spo2 and pulse rate will be recorded. |
Measured before and after procedure.
|
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
03/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
There are only few studies conducted in the field of dentistry to analyses the effect of aromatherapy with Ylang Ylang essential oil on dental anxiety and pain in children during local anaesthesia procedure. Hongratanaworakit et al in 2004 found out that compared to an odourless placebo, ylang ylang oil caused significant decrease in blood pressure and pulse rate as well as significant increases of subjective attentiveness and alertness. |