| CTRI Number |
CTRI/2024/06/069017 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the degree of pain and behaviour of children during two injection techniques in dental clinic. |
|
Scientific Title of Study
|
Comparative evaluation of pain perception and behavior of 7-9 year old children during local anesthesia administration using starpen and conventional local anesthesia delivery systems: a randomized clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanket Sanger |
| Designation |
Postgraduate student |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital Bangalore |
| Address |
Department of Pediatric and Preventive Dentistry
Sri Rajiv Gandhi College of Dental Sciences and Hospital RGC campus Hebbal R T Nagar Post BANGALORE
Bangalore 560032
Karnataka India
Bangalore
KARNATAKA
560032
India |
| Phone |
8918601947 |
| Fax |
|
| Email |
sangersanket98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umme Azher |
| Designation |
Professor |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital Bangalore |
| Address |
Department of Pediatric and Preventive Dentistry
Sri Rajiv Gandhi College of Dental Sciences and Hospital RGC campus Hebbal R T Nagar Post BANGALORE
Bangalore 560032
Karnataka India
Bangalore
KARNATAKA
560032
India |
| Phone |
9945352984 |
| Fax |
|
| Email |
drummeazher@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanket Sanger |
| Designation |
Postgraduate student |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital Bangalore |
| Address |
Department of Pediatric and Preventive Dentistry
Sri Rajiv Gandhi College of Dental Sciences and Hospital RGC campus Hebbal R T Nagar Post BANGALORE
Bangalore 560032
Karnataka India
Bangalore
KARNATAKA
560032
India |
| Phone |
8918601947 |
| Fax |
|
| Email |
sangersanket98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry Sri Rajiv Gandhi College of Dental Sciences and Hospital Bangalore 560032 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Sanket Sanger |
| Address |
Department of Pediatric and Preventive Dentistry Sri Rajiv Gandhi College of Dental Sciences and Hospital RGC campus Hebbal R T Nagar Post Bangalore 560032
Karnataka
India |
| 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 |
| Sanket Sanger |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
Room number 10
Department of Pediatric and Preventive Dentistry
Bangalore
KARNATAKA |
8918601947
sangersanket98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Sri Rajiv Gandhi College of Dental Sciences and Hospital Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional local anesthetic syringe |
Septodont syringe. Lightweight construction using surgical-grade stainless steel. no removable parts for simplified operation and maintenance.
Duration of the procedure 3 minutes. |
| Intervention |
Starpen electronic dental anesthesia system |
Starpen is an electronic dental anesthesia system. Pen style ergonomic and lightweight design for ease of use. Works with all standard anesthetic cartridges and dental needles.
Duration of the procedure 5 minutes. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children in the age group of 7-9 years requiring extraction of teeth using supra periosteal local anesthesia.
No history of an unpleasant experience in medical or dental settings.
No previous history of intra-oral injections.
Only cooperative children with a positive behavior rating of 3 or 4 on Frankl’s behavior rating scale.
No cognitive impairment.
Patients with American Association of Anesthesiologists-I (ASA I) health status.
Written informed consent from parents.
|
|
| ExclusionCriteria |
| Details |
Medically and mentally compromised children.
Active sites of pathosis in the site of injection.
Family history of allergy to local anesthesia.
Children with a recent history of hospitalization.
Unwilling and unaccompanied children.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain perception |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved behaviour |
5 minutes after local anesthesia administration |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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
Modification(s)
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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="8"
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 present study is a single-blind, two-armed, parallel-group, randomized clinical trial. Forty - eight participants in the age group of 7-9 years will be recruited from the outpatient
department (OPD) of the Department of Pediatric and Preventive Dentistry, Sri Rajiv
Gandhi College of Dental Sciences & Hospital, Bengaluru, Karnataka. After obtaining the written informed consent, the participants will be randomly allocated
into two groups by the block randomization method using a computer-generated list.
Allocation will be performed by a trial-independent individual.
Groups:
Group I: (Experimental group, n = 24) will receive local anesthesia with the aid of a Starpen
(WOODPECKER)® dental anesthesia device.
Group II: (Control group, n = 24) will receive local anesthesia with the aid of a conventional
local anesthetic syringe. Before the commencement of the treatment, all the participants’ heart rates will be recorded
using a finger pulse oximeter. The local anesthetic agent and the needle used will be
standardized, i.e.,2% lignocaine with 1:80000 adrenaline will be administered using a 30
gauge needle. The topical anesthetic gel will be applied and left in contact with the soft tissue for 1 minute after drying the tissues with 2x2 cm gauze.
Group I: for the supra periosteal anesthesia using Starpen (WOODPECKER)®, the
procedure will be followed as specified by the manufacturer.
Group II: Supraperiosteal injection will be given using the conventional metal syringe.
During injection, the heart rate and objective assessment of the pain-related behavior of the
child will be recorded following both buccal and palatal infiltration individually using the
Sound, Eye, and Motor (SEM) scale.
The pain perception of the participants will be assessed subjectively following injection
using the Wong-Baker FACES pain rating scale.
The objective and subjective assessment will be done by two trained trial-independent
evaluators separately. |