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CTRI Number  CTRI/2024/10/075722 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Fragrance Therapy for Kids: A Study on Reducing Stress in Dental Treatments in children 
Scientific Title of Study   Impact of aroma therapy on salivary cortisol levels among children undergoing dental treatment – Randomized controlled 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 Polavarapu Venkata Abhinaya 
Designation  Postgraduate student 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7981153858  
Fax    
Email  drabhinayapv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Polavarapu Venkata Abhinaya 
Designation  Postgraduate student 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7981153858  
Fax    
Email  drabhinayapv@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kalyan Chakravarthy 
Designation  Associate Professor 
Affiliation  Manipal College of Dental Sciences, Manipal 
Address  Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9916036303  
Fax    
Email  kalyan.cp@manipal.edu  
 
Source of Monetary or Material Support  
Room no 8, Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal, 576104, Karnataka, India 
 
Primary Sponsor  
Name  Dr Polavarapu Venkata Abhinaya 
Address  Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal, 576104, Karnataka, India 
Type of Sponsor  Other [Self funded] 
 
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 Polavarapu Venkata Abhinaya  Manipal College of Dental Sciences, Manipal  Room no 8, Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal, 576104, Karnataka, India
Udupi
KARNATAKA 		 7981153858

drabhinayapv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital, Institutional Ethics Committee - 1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy school students between the ages of 12 and 15 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aroma therapy, Commercially available Air freshener  For the intervention group, a commercially available automatic air freshener can be set to release Lavender fragrance at intervals ranging from 4-5 minutes, depending on what is pre-determined by the manufacturer. and the dental treatment (scaling or restoration) would be performed between 9 am and 12 pm to monitor cortisol levels 
Comparator Agent  No aroma therapy  Only the standard care of dental treatment (scaling or restoration) would be performed between 9 am and 12 pm to monitor cortisol levels. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Participants between the ages of 12 and 15 years old will be included in the study.
2. Children who were Frankle + behavior (children who accept treatment with cautious behavior at times; willing to comply with the dentist and follow the dentist’s direction cooperatively).
3. Children who require a simple dental restoration and scaling will be included.
4. Participants who are willing to give the parental informed consent form and verbal ascent and are willing to participate in the study. 
 
ExclusionCriteria 
Details  1. Patients with asthma, common cold, tonsillar adenoidal enlargement, patients requiring nasal airways, chronic obstructive pulmonary disease, psychiatric diseases, and complex cardiac conditions will be excluded from the study.
2. Participants who are uncooperative during the treatment and not willing to continue the treatment will be excluded. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of aroma therapy in reducing child stress during dental treatment by comparing the salivary cortisol levels and hemodynamic parameters.  at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   04/11/2024 
Date of Study Completion (India) 21/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="11"
Days="29" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Dental anxiety during treatment has been identified as a major problem in children and is considered an obstacle in rendering quality dental care. In a dental setting, the needles, drilling sounds, smells of cut dentin, and the sensation of high-frequency vibration often precipitate anxiety and can lead to stress. Stress can elevate cortisol levels and can lead to increased anxiety and hemodynamic parameters. Salivary cortisol levels are known to highly correlate with serum cortisol levels and have many advantages such as non-invasive sample collection and a high acceptability among the patients. 

To counteract the precipitating factors of anxiety and stress, Psychotherapeutic interventions like communication skills, trust building, Relaxation techniques like deep breathing, muscle relaxation, Behavior-management techniques, and recently, the use of cognitive behavior therapy has been highly successful. Aromatherapy is one such alternative, non-invasive, economical technique in which patients experience pleasant aroma during dental treatment.

The study will be carried out by the Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal. Before starting the study IRC clearance from Manipal College of Dental Sciences, Manipal, MAHE, and IEC clearance from Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee, Manipal will be taken. 

Participants who meet the inclusion criteria will be invited to voluntarily participate in the study and accepted by an informed consent form. Participants will be block-randomized into intervention (aroma therapy) and control (without aroma therapy) groups. The standard of care dental treatment (scaling or restoration) would be performed between 9 am and 12 pm to monitor cortisol levels. The saliva sample will be collected before and after the dental treatment in both groups. For the intervention group, a commercially available automatic air freshener can be set to release Lavender fragrance at intervals ranging from 1-60 minutes, depending on what is pre-determined by the manufacturer.

During the visit, a calibrated examiner records the Hemodynamic parameters like heart rate, systolic and diastolic blood pressure, and oxygen saturation before, during, and after treatment.
 
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