| CTRI Number |
CTRI/2025/04/085417 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of effectiveness of Lignocaine gel and Balloon vine leaf extract gel on pain perception during local anaesthetic administration. |
|
Scientific Title of Study
|
Comparative evaluation of a balloon vine leaf extract gel and 2 percentage lignocaine gel as an intraoral topical anaesthetic agent in children of 6-10years: a randomized controlled trail.
|
| 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 Sahana S |
| Designation |
Post graduate |
| Affiliation |
AME S dental college and hospital, bijangera, raichur, karnataka |
| Address |
Department of pedodontics and preventive dentistry, ame dental college and hospital, bijangera, raichur, karnataka
Raichur
KARNATAKA
584103
India |
| Phone |
9663902139 |
| Fax |
|
| Email |
sahanasridhar14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRRAGHAVENDRA HAVALE HAVALE |
| Designation |
Professor and Head of department |
| Affiliation |
AME S dental college and hospital, bijangera, raichur, karnataka |
| Address |
Department of pedodontics and preventive dentistry, ame dental college and hospital, bijangera, raichur, karnataka
Raichur
KARNATAKA
584103
India |
| Phone |
944840730 |
| Fax |
|
| Email |
raghavendrahavale@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DRSHRUTHA S P |
| Designation |
PROFESSOR |
| Affiliation |
ame dental college and hospital, bijangera, raichur, karnataka |
| Address |
Department of pedodontics and preventive dentistry, ame dental college and hospital, bijangera, raichur, karnataka
Raichur
KARNATAKA
584103
India |
| Phone |
9483329406 |
| Fax |
|
| Email |
shruthavinit@gmail.com |
|
|
Source of Monetary or Material Support
|
| AMES Dental college and Hospital bijingera road, Raichur
KARNATAKA 584103 |
|
|
Primary Sponsor
|
| Name |
Dr Sahana S |
| Address |
AMES Dental college and Hospital bijingera road, Raichur
KARNATAKA 584103 |
| 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 Sahana S |
AMES Dental college and Hospital |
Bijangera road, raichur, karnataka 584103
Raichur
KARNATAKA |
09663902139
sahanasridhar14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe of AME s Dental college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Necrosis of pulp |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lignocaine gel |
Lox 2% gel is applied in the
buccal vestibule of maxilla or
mandible on any side of arch
for 1min, prior to intraoral
injection |
| Intervention |
Balloon vine leaf extract gel |
Balloon vine leaf extract gel is applied in the buccal vestibule of maxilla or mandible on any side of arch for 1min, prior to intraoral injection |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children with good general health, Frankel Behaviour rating of 3 and 4, requiring administration of local anesthesia, willing to participate with parents consent are included |
|
| ExclusionCriteria |
| Details |
Medically compromised children,
children with active pathosis in the injection region and any history of allergy to Local Anaesthesia are excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare & evaluate the pain perception
following topical application of balloon vine leaf extract gel & commercially 2% ligocaine gel |
1 min after application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate any adverse effects following their application |
10mins after application |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2025 |
| 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="0"
Days="30" |
|
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
|
Pain and fear of dental injection in children can be a significant
concern, impacting their overall dental experience
and oral health. The current study aims to compare and evaluate the pain perception following topical application of balloon vine leaf extract gel and lignocaine gel prior to intra oral injections in children. Methods: This was randomised, controlled and triple blinded study. 30 children aged 6-10 years requiring administration of
Local anesthesia were included in the study. Each sample was
again divided into two groups, Group I (n=15) Balloon vine leaf extract gel,
Group II (n=15) lignocaine gel were applied as Pre anaesthetic agents
followed by administration of Local anesthesia.
Pulse oximeter was used to assess the anxiety levels before,
during and after LA administration. Pain perception for needle
insertion was analysed subjectively by Memoji’s Pain Scale and objectively by Sound, Eye, Motor, (SEM)scale. All the recorded data were tabulated and
statistically analysed by Paired t-test(P<0.05).
|