| 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
|
|
|
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
|
|
|
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
|
AIM: To 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.
|