| CTRI Number |
CTRI/2024/03/063752 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
To Compare and Evaluate Dental Anxiety and Fear In Children By Using Four different syringes for dental anesthesia
|
|
Scientific Title of Study
|
Comparative Evaluation Of Dental Anxiety & Fear In Children By Using Star Pen-dental Anaesthesia Device, Vibrajet, Insulin Syringe And Camouflaged LA Syringe During Local Anaesthesia Administration
|
| 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 Madhuri Bavaji Bhandare |
| Designation |
PG Student |
| Affiliation |
jawahar medical foundation annasaheb chudaman patil memorial dental college |
| Address |
Department of Pedodontics room no 5, 2nd floor,jawahar medical foundation annasaheb chudaman patil memorial dental college,Dhule
Dhule MAHARASHTRA 424001 India |
| Phone |
9503156682 |
| Fax |
|
| Email |
bhandaremadhuri09@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prashant Arjun Bondarde |
| Designation |
Head Of Department, Professor |
| Affiliation |
jawahar medical foundation annasaheb chudaman patil memorial dental college |
| Address |
Department of Pedodontics room no 5, 2nd floor,jawahar medical foundation annasaheb chudaman patil memorial dental college,Dhule
Dhule MAHARASHTRA 424001 India |
| Phone |
9370309008 |
| Fax |
|
| Email |
bondardeprashant@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Madhuri Bavaji Bhandare |
| Designation |
PG Student |
| Affiliation |
jawahar medical foundation annasaheb chudaman patil memorial dental college |
| Address |
Department of Pedodontics room no 5, 2nd floor,jawahar medical foundation annasaheb chudaman patil memorial dental college,Dhule
Dhule MAHARASHTRA 424001 India |
| Phone |
9503156680 |
| Fax |
|
| Email |
bhandaremadhuri09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawahar medical foundation annasaheb chudaman patil memorial dental college Dhule |
|
|
Primary Sponsor
|
| Name |
Dr Madhuri Bhandare |
| Address |
Department of Pedodontics room no 5, 2nd floor,jawahar medical foundation annasaheb chudaman patil memorial dental college,Dhule |
| 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 Madhuri Bhandare |
jawahar medical foundation annasaheb chudaman patil memorial dental college dhule |
Room no 5 second floor Department of pedodontics jawahar medical foundation annasaheb chudaman patil memorial dental college dhule Dhule MAHARASHTRA |
9503156680
bhandaremadhuri09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| jawahar medical foundation annasaheb chudaman patil memorial dental college institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
camouflaged LA syringe |
For local anaethesia administration during any dental treatment monitoring the anxiety level within 20 minutes |
| Comparator Agent |
insulin syringe |
For local anaethesia administration during any dental treatment monitoring the anxiety level within 20 minutes |
| Intervention |
Starpen –dental anaesthesia device |
For local anaethesia administration during any dental treatment monitoring the anxiety level within 20 minutes |
| Comparator Agent |
VibraJet –dental anaesthesia device |
For local anaethesia administration during any dental treatment monitoring the anxiety level within 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children having their first dental visit
Healthy children with no systemic illness, allergies, etc.
Cooperative child.
Patient requiring local anesthetic injection for dental treatment either in maxillary or
mandibular arch.
Children with proper parental consent |
|
| ExclusionCriteria |
| Details |
Children with emergency treatment needs, such as abscess, cellulitis and space
infection, and those who needed premedication for receiving dental treatment.
Medically compromised patient
Children with behavioural management problem
Children allergic to local anesthetic agents.
Children below 6 years of age |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate dental anxiety & fear in children by using star pen-dental anaesthesia device, vibrajet, insulin syringe and camouflaged l.a syringe during local anaesthesia administration
|
At the time before and after local anaesthesia
delivery prior treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare dental anxiety & fear in children by using star pen-dental anaesthesia device,
|
At the time before & after local anaesthesia
delivery prior treatment |
| To compare dental anxiety & fear in children by using Vibrajey |
At the time before & after local anaesthesia
delivery prior treatment |
| To compare dental anxiety & fear in children by using Insulin syringe |
At the time before & after local anaesthesia
delivery prior treatment |
| To compare dental anxiety & fear in children by using camouflaged syringe |
At the time before & after local anaesthesia delivery prior treatment |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/03/2024 |
| Date of Study Completion (India) |
11/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
11/06/2024 |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhandaremadhuri09@gmail.com].
- For how long will this data be available start date provided 26-05-2024 and end date provided 27-05-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
INTRODUCTION:-
Dental fear and anxiety is one of the
major challenges in pediatric dentistry . DFA is a common reason for avoiding
dental treatment, which over time, may result in deteriorated oral health. Some
children find it difficult to cope with the stimuli and behavioral demands
associated with dental experience. This could be due to fear of the needle,
bodily harm, or a general fear of the unknown. Successful treatment of
pediatric patients, in terms of allaying their anxiety and discomfort during
restorative and surgical procedures, is facilitated by profound local anesthesia
In order to overcome this, many
advanced injection techniques have been implemented. The most recent and
advanced technique was using a Starpen-local anaesthetic device .and
VibraJet-small vibrating device to
deliver dental anaesthesia. METHODOLOGY- Patient who satisfied the inclusion and exclusion criteria will
be randomly divided into four groups consisting 10 patients each i.e. Group 1- Starpen
–dental anaesthesia device , Group 2 – VibraJet –dental anaesthesia device, Group 3- Insulin Syringe and
Group 4- Camouflaged L.A syringe ,Local anesthetic (LOX × 2% adrenaline) is
delivered according to assigned group in the area adjacent to the tooth
requiring invasive treatment procedure.
Preoperative
evaluation will be done before local anaesthesia admininistration by recording
pulse rate and Venhams Picture Test which comprices 8 cards with 2 picture in
each card one anxious and one non anxious.
The score ranges from 0 to 8 maximum
score . Facial Image Scale - A subjective scale used to assess pain- A set of
six cartoon faces will be shown to the child with varying facial expressions
ranging from a very smiling face to a very sad face. A brief explanation will
be given to the child about each face after which the child was instructed to
choose the face that best described his/ her feelings before and after local
anesthesia-Scores from 1 to 4. |