| CTRI Number |
CTRI/2024/08/072603 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare how much pain children feel while receiving Local Anesthetic Injection , using either Transcutaneous Electrical Nerve Stimulation (TENS) device or Combination of External Cold and Vibration device. |
|
Scientific Title of Study
|
Comparative evaluation of Transcutaneous Electrical Nerve Stimulation and Combination of External Cold and Vibration for pain perception during administration of Local Anesthesia in pediatric dental patients – An in vivo study
|
| 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 Nitika Bajaj |
| Designation |
Professor |
| Affiliation |
Baba Farid University of Health Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, Dasmesh Institute of Research and Dental Sciences, Talwandi road, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9876194481 |
| Fax |
|
| Email |
drnitika_bajaj81@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishtha Sardana |
| Designation |
Post Graduate Student |
| Affiliation |
Baba Farid University of Health Sciences |
| Address |
Dasmesh Institute of Research and Dental Sciences, Talwandi road, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
8283996443 |
| Fax |
|
| Email |
dr.nishthasardana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishtha Sardana |
| Designation |
Post Graduate Student |
| Affiliation |
Baba Farid University of Health Sciences |
| Address |
Dasmesh Institute of Research and Dental Sciences, Talwandi road, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
8283996443 |
| Fax |
|
| Email |
dr.nishthasardana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dasmesh Institute of Research and Dental Sciences, Talwandi Road, Faridkot |
|
|
Primary Sponsor
|
| Name |
Dr Nishtha Sardana |
| Address |
Dasmesh Institute of Research and Dental Sciences, Talwandi Road, Faridkot, Punjab, India, 151203. |
| 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 Nishtha Sardana |
Dasmesh Institute of Research and Dental Sciences |
Department of Pediatric and Preventive Dentistry
Faridkot
PUNJAB |
8283996443
dr.nishthasardana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD (ETHICAL COMMITTEE) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, (2) ICD-10 Condition: K083||Retained dental root, (3) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combination of external cold and vibration (Buzzy®, Pain Care Labs) |
The child will be first made familiar to the device by explaining how it works in simple words, then the child will be allowed to play with Buzzy® in order to familiarize with the device. Buzzy® with freezed wings will be placed extra-orally above the area/cheek where local anesthetic is to be delivered. Local anesthetic will be delivered using conventional 2 mL syringe in the area adjacent to the tooth requiring treatment and pain assessment will be done before and after administration of local anesthesia.
|
| Comparator Agent |
Conventional Syringe |
After the patient will be seated on the dental chair, Local anesthetic will be delivered using conventional 2 mL syringe in the area adjacent to the tooth requiring treatment and pain assessment will be done before and after administration of local anesthesia.
|
| Intervention |
Transcutaneous Electrical Nerve Stimulation |
After the child will be seated on the dental chair, he/she will be first made familiar to the device by explaining how it works in simple words and then the electrode pads of TENS will be applied extraorally above the area where local anesthetic is to delievered. Local anesthetic will be delivered using conventional 2 mL syringe in the area adjacent to the tooth requiring treatment and pain assessment will be done before and after administration of local anesthesia.
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children with no systemic illness.
cooperative child.
children requiring local anesthesia.
children with no allergy to local anesthesia.
children with proper parental consent.
children with no skin abrasion. |
|
| ExclusionCriteria |
| Details |
Children with known systemic disease.
children with behavioural management problems.
children with known allergy to local anethesia.
children with skin conditions liked eczema or skin abrasions.
children below 5 years of age.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the pain perception during administration of local anesthesia using Transcutaneous Electrical Nerve Stimulation and combination of external cold and vibration in pediatric dental patients. |
The pain assessment will done before and after the administration of local anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient acceptance will be assessed. |
Before the administration of Local Anesthesia |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
26/08/2024 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (dr.nishthasardana@gmail.com).
- For how long will this data be available start date provided 01-09-2024 and end date provided 01-09-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
THE PURPOSE OF THIS STUDY IN- VIVO STUDY WILL BE TO EVALUATE AND COMPARE THE PAIN PERCEPTION DURING ADMINISTRATION OF LOCAL ANESTHESIA USING TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION AND COMBINATION OF EXTERNAL COLD AND VIBRATION IN PEDIATRIC DENTAL PATIENTS.Ninety healthy,
cooperative children of age group 5-10 years will be selected based on the
inclusion and exclusion criteria. The selected children will be randomly
divided into three groups:
GROUP I: Transcutaneous electrical nerve stimulation group
GROUP II: Combination
of external cold and vibration group
GROUP III: Conventional syringe group
CLINICAL PROCEDURE
Before the commencement of
the treatment, the procedure will be fully explained to the patient and
patient’s parent in simple words, with the main criteria being administration
of local anesthesia. Informed consent will be taken. The pain assessment will
be done using Wong Baker’s faces pain rating scale before the administration of
anesthesia.
Group I (Transcutaneous Electrical Nerve Stimulation Group): After the child will be
seated on the dental chair, he/she will be first made familiar to the device by
explaining how it works in simple words and then the electrode pads will be
applied extraorally above the area where local anesthetic is to delievered. Local
anesthetic will be delivered using conventional 2 mL syringe in the area
adjacent to the tooth requiring treatment.
Group II (Combination
of external cold and vibration Group): Buzzy® (Pain Care Labs) is a plastic gadget with cooled wings in which vibrations are combined with cold
therapy. The
child will be first made familiar to the device by explaining how it works in
simple words, then the child will be allowed to play with Buzzy® in order to
familiarize with the device. Buzzy® with freezed wings will be placed
extra-orally above the area/cheek where local anesthetic is to be delivered.
Local anesthetic will be delivered using conventional 2 mL syringe in the area
adjacent to the tooth requiring treatment.
Group III (Conventional Syringe Group): After the patient will be
seated on the dental chair, Local anesthetic will be delivered using
conventional 2 mL syringe in the area adjacent to the tooth requiring
treatment.
The pain assessment will
done after the administration of local anesthesia using Wong Baker’s faces pain
rating scale and Face, Legs, Activity, Cry, Consolability (FLACC) scale. Data will
be collected, tabulated and the values obtained will be
statistically analyzed and compared. |