| CTRI Number |
CTRI/2018/10/016198 [Registered on: 30/10/2018] Trial Registered Prospectively |
| Last Modified On: |
06/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Needle in the Cloak is the Clinician’s Master Stroke |
|
Scientific Title of Study
|
Comparing the conventional syringe with camouflage syringe by evaluating behavior and anxiety in 6 -10 year old children while administering local anesthesia – A cross over trial with split mouth study design |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Padminee Krishnan |
| Designation |
1st year Post graduate student |
| Affiliation |
Department of Pediatric and Preventive Dentistry, SRM Dental College and Hospital |
| Address |
No.19, Karthik Illam, Mandaveli street, Mandaveli, Chennai - 600028
SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai - 600089
Chennai
TAMIL NADU
600028
India |
| Phone |
|
| Fax |
|
| Email |
padminee.krish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRHemalatha |
| Designation |
Head of the Department |
| Affiliation |
Department of Pediatric and Preventive Dentistry |
| Address |
SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai - 600089
SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai - 600089
Chennai
TAMIL NADU
600089
India |
| Phone |
|
| Fax |
|
| Email |
srmpedodpt16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Padminee Krishnan |
| Designation |
1st year Post graduate student |
| Affiliation |
Department of Pediatric and Preventive Dentistry, SRM Dental College and Hospital |
| Address |
No.19, Karthik Illam, Mandaveli street, Mandaveli, Chennai - 600028
SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai - 600089
Chennai
TAMIL NADU
600028
India |
| Phone |
|
| Fax |
|
| Email |
padminee.krish@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Padminee Krishnan |
| Address |
NO.19, karthik Illam, Mandaveli Street, Mandaveli, Chennai - 600028 |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Padminee Krishnan |
SRM Dental College and Hospital |
Department of Pediatric and Preventive Dentistry, 3rd Floor, PG Block 2, SRM Dental College and Hospital,Bharathi Salai, Ramapuram, Chennai - 600089
Chennai
TAMIL NADU |
9710066890
padminee.krish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board SRM Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F418||Other specified anxiety disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Camouflage syringe |
The short needle 2.5ml disposable syringe will be used for administering Local anesthesia |
| Intervention |
Camouflage syringe |
The syringe sleeve to camouflage the needle will be of different cartoon characters. The sleeve will be provided with a loop so that the disposable syringe can be slid into it. The syringe sleeve is removable and hence after the procedure can be used as a finger puppet. This will be given to the kid as reward (positive reinforcement) after the treatment. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with no past dental experience
2.Children with no medical complications
3.Children who require treatment under Local anesthesia in 2 different quadrants
4.Children and parent willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Children with special health care needs’
2.Children allergic to local anesthesia
3.Children who require treatment under local anesthesia in only one quadrant
4.Children and parents who are not willing to participate
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart Rate, Oxygen saturation
|
Using Pulse oximeter before, during and after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FLACC score -Face, Legs, Activity, Cry and Consolability |
During administration of local anesthesia |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
31/10/2018 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dental fear
and anxiety are widely prevalent among children deteriorating their cooperation
during dental procedures. One major cause for dental fear and anxiety is the
procedural intervention with needles and syringes. The visual impact created on
the sight of the needle deters the child’s cooperation towards the treatment.
Hence in the current study, the use of camouflage syringe was compared with
conventional syringe by assessing the behavior and anxiety of the child. |