| CTRI Number |
CTRI/2024/11/077086 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of ajwain oil application in pain control during injection in children |
|
Scientific Title of Study
|
Effectiveness of topical application of Trachyspermum Ammi (ajwain) oil in pain control during local anesthesia administration in pediatric dental patients: 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 Aatya Takuli |
| Designation |
post graduate student |
| Affiliation |
teerthanker mahaveer dental college and research centre |
| Address |
room 617, department of pedodontics and preventive dentistry, teerthanker mahaveer dental college and research centre, moradabad (UP) 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8449441551 |
| Fax |
|
| Email |
aatyatakuli10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akash Bhatnagar |
| Designation |
associate professor |
| Affiliation |
teerthanker mahaveer dental college and research centre |
| Address |
room 617, department of pedodontics and preventive dentistry, teerthanker mahaveer dental college and research centre, moradabad (UP) 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9897122663 |
| Fax |
|
| Email |
akashbhatnagar.dental@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aatya Takuli |
| Designation |
post graduate student |
| Affiliation |
teerthanker mahaveer dental college and research centre |
| Address |
room 617, department of pedodontics and preventive dentistry, teerthanker mahaveer dental college and research centre, moradabad (UP) 244001
UTTAR PRADESH
244001
India |
| Phone |
8449441551 |
| Fax |
|
| Email |
aatyatakuli10@gmail.com |
|
|
Source of Monetary or Material Support
|
| teerthanker mahaveer dental college and research center |
|
|
Primary Sponsor
|
| Name |
Dr Aatya Takuli |
| Address |
room 617, department of pedodontics and preventive dentistry, teerthanker mahaveer dental college and research centre, moradabad (UP), india, 244001 |
| Type of Sponsor |
Other [self funded by principal investigator] |
|
|
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 Aatya Takuli |
teerthanker mahaveer dental college and research centre, moradabad (UP) |
department of pedodontics and preventive dentistry, teerthanker mahaveer dental college and research centre, moradabad (UP) 244001
Moradabad
UTTAR PRADESH |
8449441551
aatyatakuli10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMDCRC/IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient requiring local anaesthesia (block) in either maxilla or mandible for dental
procedures |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepaH (viShopakramaH), लेपः (विषोपकà¥à¤°à¤®à¤ƒ) | (Procedure Reference: Comparative evaluation of pain perception following topical application of clove oil, betel leaf extract, lignocaine gel, and ice prior to intraoral injection in children aged 6-10 years: a randomized control study, Procedure details: selected topical gel was applied to the determined site using a cotton applicator before injection. The patient’s behavior was evaluated for pain
perception during insertion of the needle using the WBFPRS scale)
| | 2 | Comparator Arm (Non Ayurveda) | | - | topical anesthetic spray | topical spray is to be applied to the determined site using a cotton applicator before injection. The patient’s behavior was evaluated for pain perception during insertion of the needle using the WBFPRS scale) |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Patient requiring local anaesthesia (block) in either maxilla or mandible for dental
procedures. |
|
| ExclusionCriteria |
| Details |
Children suffering from any systemic disease, Patients with Aichmophobia, Patient with history of abscess, redness and fistula at the injection site, Children who refuse to participate in the study. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
A sample size of 52 (26 per group) would yield 80% power to detect significant
differences, with assuming the effect size of 0.8 and significance level at 0.05 |
after 5 minutes and 30 minutes after topical application. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| suggested oil may not be as effective as traditional spray |
after 5 minutes & 30 minutes after topical application |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
30/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="5" |
|
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
|
A total of 52 children of age from 6-10 years, who met the inclusion criteria, will be assigned
into 2 groups: Group 1 (study group) and Group 2 (control group), Group 1 will comprise of topical application of T. ammi oil before administering
local anaesthesia and Group 2 will comprise of topical application of local anaesthesia spray before
administering local anaesthesia. The T. ammi oil used in this study is 100% food grade essential oil readily
available in the market, This concentrated oil is diluted in ethyl alcohol for topical application. This
process will take place in College of Pharmacy, Teerthanker Mahaveer
University, Moradabad, The prepared oil will be stored in a black glass bottle, The oil will be freshly prepared daily for usage until the desired sample is
achieved, The child and parent are explained about the procedure and pain rating scales, Tell show do technique for behaviour management, In group 1 T. ammi oil will be applied topically to the determined site using a
cotton applicator, In group 2 only topical anaesthetic spray will be applied to the mucosa at the
site of injection, Local anaesthesia will be administered in the respective nerve within 5min, The injection will be performed slowly, preceded by aspiration to prevent
intravascular adverse effect, The pain perception during injection will be recorded immediately after the
procedure using pain rating scales i.e. VAS and WB-F Pain Rating Scale and
biologic parameters, Thus the values obtained will be subjected to statistical analysis. |