| CTRI Number |
CTRI/2024/06/068658 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of effectiveness of self aspirating syringe and buzzy system in reducing pain and anxiety among 6-10 year old children |
|
Scientific Title of Study
|
A comparative evaluation of the effectiveness of three different local anesthesia delivering systems in reducing pain and anxiety among 6-10 year old children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lavanya Mangala Valli M |
| Designation |
Post graduate student |
| Affiliation |
Chettinad Dental College and Research Institute Tamil Nadu |
| Address |
dept of pedodontics and preventive dentistry, room no 6B,
Chettinad dental college and research institute
Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
08300928284 |
| Fax |
|
| Email |
lavanyamangalavalli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
senthil eagappan |
| Designation |
professor |
| Affiliation |
Chettinad Dental College and Research Institute Tamil Nadu |
| Address |
department of pedodontics and preventive dentistry, room no 6B,
CHETTINAD DENTAL COLLEGE AND RESEARCH INSTITUTE
KELAMBAKKAM
TAMIL NADU
603103
India |
| Phone |
08300928284 |
| Fax |
|
| Email |
dr.eaga_ars@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
LAVANYA MANGALA VALLI M |
| Designation |
Post graduate student |
| Affiliation |
Chettinad Dental College and Research Institute Tamil Nadu |
| Address |
DEPAARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY, ROOM NUMBER 6B,
CHETTINAD DENTAL COLLEGE AND RESEARCH INSTITUTE
KELAMBAKKAM
TAMIL NADU
603103
India |
| Phone |
08300928284 |
| Fax |
|
| Email |
lavanyamangalavalli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Dental College and Research Institute,
KELAMBAKKAM,
KANCHIPURAM. TAMIL NADU, INDIA 603103 |
|
|
Primary Sponsor
|
| Name |
Kasthuri |
| Address |
4/126A, Yadhava street, Tirumalaiappapuram, Tirunelveli , TAMIL NADU, INDIA
PIN- 627423 |
| 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 Lavanya Mangala Valli |
Chettinad Dental College and Research Institute |
dept of pedodontics and preventive dentistry,room number 6
CHETTINAD DENTAL COLLEGE AND RESEARCH INSTITUTE
KELAMBAKKAM
Chennai
TAMIL NADU |
08300928284
lavanyamangalavalli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee For Student Research ( CARE IHEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K027||Dental root caries, (2) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
administration of lignocaine using buzzy system |
anxiety and pain measured before and after the administration of lignocaine using buzzy system |
| Intervention |
administration of lignocaine using self aspirating syringe |
anxiety and pain of the patient measured before and after the administration of local anesthesia using self aspirating syringe |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Healthy 6 – 10-year-old children with no systemic illness and allergies.
Frankel positive child
Patient requiring inferior alveolar nerve block for dental treatment.
Children with proper parental consent.
|
|
| ExclusionCriteria |
| Details |
1. Children with known systemic diseases.
2. Uncooperative Child
3. Children with known allergy to local anesthetic agents.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of anxiety and pain |
Before and after the delivery of local anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparing the effectiveness between two techniques in which there is minimal pain & discomfort during delivery of local anesthesia. |
before when patient in waiting area anxiety & pain is measured ; after the administration of local anesthesia using these techniques pain & anxiety is measured. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
24/06/2024 |
| 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="3"
Days="0" |
|
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
|
the study is aimed to compare the effectiveness of two different local anesthesia delivering system in reducing pain and anxiety among children. dental office is the most anxiety provoking environment for children to make the treatment effective and pleasant experience these techniques play a vital role. delivering local anesthesia in syringe triggers anxiety in children therefore there are various delivering techniques available .Once the study is completed, it will be published in a good dental domain journal which will be useful for all the clinicians. |