| CTRI Number |
CTRI/2023/09/057615 [Registered on: 14/09/2023] Trial Registered Prospectively |
| Last Modified On: |
11/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Lavender and Rose Aromatherapy during root canal treatment |
|
Scientific Title of Study
|
Comparative Evaluation of Lavender and Rose Aromatherapy on Success Rate of Inferior Alveolar Nerve Block in Teeth with Irreversible Pulpitis: A Prospective, Block Randomized Clinical Trial |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| priya.mittal@sdk-dentalcollege.edu.in |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Mittal |
| Designation |
Assistant Professor |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Nagpur |
| Address |
Department of conservative dentistry, Swargiya dadasaheb kalmegh smruti dental college and hospital
wanadongri, hingna
Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
09899895542 |
| Fax |
|
| Email |
priya.mittal@sdk-dentalcollege.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Priya Mittal |
| Designation |
Assistant Professor |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Nagpur |
| Address |
Department of conservative dentisrty and endodontics, swargiya dadasaheb kalmegh smruti dental college and hospital, wanadongri, hingna
Nagpur
MAHARASHTRA
441110
India |
| Phone |
09899895542 |
| Fax |
|
| Email |
priya.mittal@sdk-dentalcollege.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Priya Mittal |
| Designation |
Assistant Professor |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Nagpur |
| Address |
department of conservative dentistry and endodontics, Swargiya dadasaheb kalmegh smruti dental college and hospital, wanadongri, hingna
Nagpur
MAHARASHTRA
441110
India |
| Phone |
09899895542 |
| Fax |
|
| Email |
priya.mittal@sdk-dentalcollege.edu.in |
|
|
Source of Monetary or Material Support
|
| swargiya dadasaheb kalmegh smruti dental college and hospital, wanadongri, hingna , 441110 |
|
|
Primary Sponsor
|
| Name |
Swargiya dadasaheb kalmegh smruti dental college and hospital |
| Address |
Swargiya dadasaheb kalmegh smruti dental college and hospital, wanadongri, hingna |
| Type of Sponsor |
Private medical college |
|
|
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 Priya Mittal |
Swargiye Dadasaheb Kalmegh Smruti Dental College and Hospital |
Department of conservative dentistry and endodontics,2nd floor, room no 206, wanadongri, hingna, 441110
Nagpur
MAHARASHTRA |
9899895542
priya.mittal23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swargiya dadasaheb kalmegh smruti dental college and hospital, Dist Nagpur, Institutional ethical committeeional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy patients with carious teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aromatherapy |
lavender and rose aroma will be used |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
teeth with irreversible pulpitis |
|
| ExclusionCriteria |
| Details |
pregnant patients
patients with insomnia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
anxiety
pain |
anxiety
pain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2023 |
| 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="0"
Days="15" |
|
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 - YES
- What data in particular will be shared?
Response (Others) - result of study
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response (Others) - result
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identiļ¬ed for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - publication in indexed journal
- For how long will this data be available start date provided 25-09-2023 and end date provided 25-10-2023?
Response (Others) - Dear sir/mam these are tentative dates, i will start procedure after registration from CTRI.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Objective: This prospective, block randomized clinical trial will be conducted to evaluate the effect of lavender and rose aromatherapy on the success rate of inferior alveolar nerve block (IANB) in teeth with irreversible pulpitis. Method and materials: In this clinical trial, 39 patients fulfilling the inclusion criteria will be randomly divided into three equal groups: group I (n=13) would receive IANB in closed operatory room without any fragrance, group II (n=13) IANB in separate closed operatory saturated with lavender fragrance using candle warmer and group III (n=13) IANB in separate closed operatory with rose fragrance using candle warmer. The modified dental anxiety scale (MDAS) for anxiety and visual analogue scale (VAS) for pain will be used preoperatively as well as during access cavity preparation. For MDAS, total score of more than 18 will be considered as tremendously anxious or dental phobic. No or mild pain on VAS will be considered as success. Data will be analyzed statistically |