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CTRI Number  CTRI/2024/10/075946 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 16/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial of the effects of two essential oil aromatherapy, ylang-ylang flower essential oil and lavender flower essential oil, in children for Dental Anxiety management  
Scientific Title of Study   Comparison of safety and effectiveness of Ylang- ylang flower (Cananga Odorata) essential oil in aromatherapy in reducing anxiety in 6-10 year old children in their first restorative treatment appointment- A Randomized control 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  Dr Amol N Patil 
Designation  Associate Professor 
Affiliation  SMBT Dental College and Hospital Amrutnagar Sangamner 
Address  Department of Pediatric and Preventive Dentistry SMBT Dental College and Hospital Amrutnagar Sangamner

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9970054298  
Fax    
Email  dramolnpatil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sneha N Kamble 
Designation  PG student 
Affiliation  SMBT Dental College and Hospital Amrutnagar Sangamner 
Address  Department of Pediatric and Preventive Dentistry SMBT Dental College and Hospital Amrutnagar Sangamner

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  8830455356  
Fax    
Email  snehakamble7643@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sneha N Kamble 
Designation  PG student 
Affiliation  SMBT Dental College and Hospital Amrutnagar Sangamner 
Address  Department of Pediatric and Preventive Dentistry SMBT Dental College and Hospital Amrutnagar Sangamner

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  8830455356  
Fax    
Email  snehakamble7643@gmail.com  
 
Source of Monetary or Material Support  
S.M.B.T Dental College and Hospital Sangamner 
 
Primary Sponsor  
Name  Dr Sneha Nivas Kamble 
Address  Department of Pediatric Dentistry SMBT Dental College and Hospital Amrutnagar Sangamner 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sneha Kamble  SMBT Dental College and Hospital   Post graduate clinical section, Department of Pediatric and Preventive Dentistry, SMBT Dental College & Hospital Amrutnagar Sangamner
Ahmadnagar
MAHARASHTRA 
8830455356

snehakamble7643@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Committee of Ethics, SMBT Dental College, Sangamner  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lavender Flower essential oil  Lavender flower essential oils aromatherapy will be used with a 1% dilution (1 drop per teaspoon of carrier oil; 5-6 drops per ounce). Carrier oil will be jojoba oil. Every patient will have a fresh batch of diluted essential oil diffused in the room. The essential oil aromatherapy diffuser will be on for 15 minutes before the patient enters the dental setup, after which it will be turned off. 
Intervention  Ylang Ylang Flower Essential oil  Ylang Ylang flower essential oils aromatherapy will be used with a 1% dilution (1 drop per teaspoon of carrier oil; 5-6 drops per ounce). Carrier oil will be jojoba oil. Every patient will have a fresh batch of diluted essential oil diffused in the room. The essential oil aromatherapy diffuser will be on for 15 minutes before the patient enters the dental setup, after which it will be turned off. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Normal healthy, well-nourished children of age-group between 6 and 10 years.
2. Patients with prior parental consent.
3. Patients with prior assent.
4. Patients who require restorative procedures.
5. Patients who are undergoing dental treatment for the first time.
 
 
ExclusionCriteria 
Details  1. Children with common cold.
2. Prior history of allergic reactions to the aromatics.
3. Impaired psychological development.
4. Systemic diseases.
5. History of an untoward experience in the medical set up due to any prevailing medical conditions.
6. Any physical or mentally handicapping conditions.
 
 
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 
Reduction in pulse rate as an indicator for reduction in anxiety levels of the child (6-10 years old) in their first dental restorative appointment  Pulse rate will be recorded:
1. Before the beginning of the first dental restorative appointment
2. During the first dental restorative appointment 
 
Secondary Outcome  
Outcome  TimePoints 
Facial image scale score ( Anxiety rating scale) as a parameter for reduction in anxiety levels of the child (6-10 years old) in their first dental restorative appointment  Facial image scale score ( Anxiety rating scale)will be recorded :
1. Before the beginning of the first dental restorative appointment
2. During the first dental restorative appointment 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/01/2025 
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="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  

AIMTo compare the safety and effectiveness of Ylang-Ylang flower essential oil and Lavender flower essential oil in aromatherapy in reducing dental anxiety in children.

OBJECTIVE: To evaluate the safety and effectiveness of lavender flower essential oil and Ylang-Ylang flower essential oil on reducing dental anxiety and then to compare the effect of both to evaluate if there is a difference.

PRIMARY HYPOTHESIS: There is a difference in reducing the dental anxiety on using Aromatherapy with Ylang-ylang flower essential oil and Lavender Flower essential oil in 6-10-year-old children before and during the first restorative Appointment

NULL HYPOTHESIS: There is no difference in reducing the dental anxiety on using Aromatherapy with Ylang-ylang flower essential oil and Lavender Flower essential oil in 6-10-year-old children before and during First Restorative Treatment Appointment

METHODOLOGY: 60 patients fulfilling the inclusion criteria will be selected for the study.

b) Allocation of the patients into the three groups will be done randomly through the lottery method.

GROUP I (20 children): children not subjected to aromatherapy

GROUP II (20 children): children subjected to aromatherapy using Lavender Flower (Lavandula angustifolia) essential oil

GROUP III (20 children): children subjected to aromatherapy using Ylang-ylang (Cananga odorata) flower essential oil

All the participants will be counselled for the restorative procedure using "tell, show, do” technique.

Inhalation Aromatherapy essential oils will be diluted: 1% dilution (1 drop per teaspoon of carrier oil ; 5-6 drops per ounce). Carrier oil will be jojoba oil. Every patient will have a fresh batch of diluted essential oil diffused in the room.

d)     The essential oil aromatherapy diffuser will be on for 15 minutes before the patients enters the dental setup, after which it will be turned off. The patient will then be introduced to the dental environment and counselled using “tell-show-do” technique for approximately 5 minutes, after which the treatment will be started and completed in approximately 15 minutes.

e)     In Group II, children will be subjected to Aromatherapy with Lavender Flower (Lavandula angustifolia) essential oil.

f)      Group III children will be subjected to Aromatherapy with Ylang-Ylang flower (Cananga odorata) essential oil.

g)     The anxiety levels in children of all the groups will be recorded at two different intervals:

·       Before entering the dental setup

·       During procedure while using aromatherapy in first restorative appointment treatment.

·       Anxiety levels will be assessed using a facial image scale. 

 Pulse rate will be monitored using a pulse oximeter.

DATA ANALYSIS will be done as follows:

Descriptive quantitative data will be expressed in mean and standard deviation, respectively. Data normality=Shapiro-Wilk test. Inter-group comparison of means between 3 groups=one-way ANOVA test followed by post-hoc Tukey test for pairwise comparison. Intra-group comparison of means before and after completion of restorative procedure will be done with the help of paired-t test. Confidence interval=95% and probability of α error=5%. Power of study=80%. P<0.05 is considered significant.

 

 
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