| CTRI Number |
CTRI/2020/12/029937 [Registered on: 21/12/2020] Trial Registered Prospectively |
| Last Modified On: |
19/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the effect of clove oil, betel leaf extract, lignocaine gels and ice for pain reduction during intraoral injections |
|
Scientific Title of Study
|
Comparative Evaluation of pain perception following topical application of Clove Oil, Betel leaf extract, Lignocaine gels and Ice prior to intraoral injection in children aged 6-10years. - A Randomized Control Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanchan M Tuppadmath |
| Designation |
Post graduate student MDS |
| Affiliation |
Academy of Medical Education Raichur |
| Address |
Department of Pedodontics and Preventive Dentistry, Room NO. 04, A M Es Dental College and Hospital Near Government Polytechnic college Bijjanegera Road Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
9686984929 |
| Fax |
|
| Email |
kanchantuppadmath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra Havale |
| Designation |
MDS |
| Affiliation |
Academy of Medical Education Raichur |
| Address |
Department of Pedodontics and Preventive Dentistry, Room NO. 04, A M Es Dental College and Hospital Near Government Polytechnic college Bijjanegera Road Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
9448407300 |
| Fax |
|
| Email |
raghavendrahavale@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanu G |
| Designation |
MDS |
| Affiliation |
Academy of Medical Education Raichur |
| Address |
Department of Pedodontics and Preventive Dentistry, Room NO. 04, A M Es Dental College and Hospital Near Government Polytechnic college Bijjanegera Road Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
9845031755 |
| Fax |
|
| Email |
drdhanu74@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| A M Es DENTAL COLLEGE AND HOSPITAL, RAICHUR |
|
|
Primary Sponsor
|
| Name |
Dr Kanchan M Tuppadmath |
| Address |
A M Es Dental College and Hospital Bijanegera Road Near government polytechnic college Raichur |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Raghavendra Havale |
A M Es Dental College and Hospital Bijanegera Road Near government polytechnic college Raichur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kanchan M Tuppadmath |
Department of Pedodontics and Preventive Dentistry Room NO: 04, A M Es Dental College and Hospital |
Out Patient Department, Department of Pedodontics and Preventive Dentistry, Room no. 04, A M Es Dental College and Hospital Bijanegera Road Near government polytechnic college Raichur.
Raichur
KARNATAKA |
9686984929
kanchantuppadmath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe of A M Es Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K040||Pulpitis. Ayurveda Condition: DANTABEDAHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
10% Betel Leaf extract |
Applied in the buccal vestibule in maxillary anterior region for 60 seconds prior to intraoral injection |
| Comparator Agent |
2% Lignocaine Gel |
Applied in the buccal vestibule in maxillary anterior region for 60 seconds prior to intraoral injection |
| Intervention |
Clove oil |
Applied in the buccal vestibule in maxillary anterior region for 60 seconds prior to intraoral injection |
| Intervention |
Ice |
Applied in the buccal vestibule in maxillary anterior region for 60 seconds prior to intraoral injection |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
A) Children of age group of 6-10 years.
B) Children requiring administration of infiltration anesthesia irrespective of treatment.
C) Children with Frankl’s behaviour rating 3 and 4.
D) Children with good general health (ASA I).
E) Children who are willing to participate and whose parents give informed consent.
|
|
| ExclusionCriteria |
| Details |
A) Medically compromised children.
B) Patient with history of anxiety disorder.
C) Children or parents not willing to participate.
D) Patients with history of allergy to local anesthesia.
E) Patients on medication that can alter pain perception.
F) Children with active pathology at the administration site.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the pain perception following topical application of clove oil, betel leaf extract, lignocaine gels & ice prior to intraoral infilterations. |
60 seconds after the application of comparator agents |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate for any adverse effects following topical application of comparator agent |
60 seconds after the application of comparator agents |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/12/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: Current study aims to compare and evaluate pain perception following topical application of lignocaine gel, clove-based gel, ice and newly developed betel leaf extract gel during intraoral injection in children. Materials and method: 60 children aged between 6-10 years who meet inclusion criteria will be divided in four groups. Topical anesthetic agents (clove oil, betel leaf extract, lignocaine gels and ice) will be applied in respective group for one minute which is followed by administration of lignocaine infiltration using 26-gauge needle. Pain perception will be analysed subjectively by Wong Bakers FACES pain rating scale (WBFPRS) and objectively by Sound, Eye, Motor scale (SEM) scale. |