CTRI Number |
CTRI/2022/09/045460 [Registered on: 13/09/2022] Trial Registered Prospectively |
Last Modified On: |
01/02/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Other |
Public Title of Study
|
Comparing two different methods of anesthesia in children to reduce anxiety |
Scientific Title of Study
|
Comparative evaluation of the effectiveness of transcutaneous electric nerve stimulation and photobiostimulation using diode laser prior to local anesthesia administration in children undergoing bilateral orthodontic extractions: a randomised controlled clinical trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Bhawna Saxena |
Designation |
PG- Student |
Affiliation |
I.T.S Dental College Hospital and Research Centre |
Address |
I.T.S. Dental college hospital and research centre, 47,knowledge park III, greater noida, uttar pradesh
Gautam Buddha Nagar UTTAR PRADESH 201308 India |
Phone |
9769892051 |
Fax |
|
Email |
dr.bhawnasaxena@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mousumi Goswami |
Designation |
Prof. & Head department of pediatric and preventive dentistry |
Affiliation |
I.T.S Dental College Hospital and Research Centre |
Address |
I.T.S. Dental college hospital and research centre, 47,knowledge park III, greater noida, uttar pradesh
Gautam Buddha Nagar UTTAR PRADESH 201308 India |
Phone |
8588854190 |
Fax |
|
Email |
hod.pedo.gn@its.edu.in |
|
Details of Contact Person Public Query
|
Name |
Dr Bhawna Saxena |
Designation |
PG- Student |
Affiliation |
I.T.S Dental College Hospital and Research Centre |
Address |
I.T.S. Dental college hospital and research centre, 47,knowledge park III, greater noida, uttar pradesh
Gautam Buddha Nagar UTTAR PRADESH 201308 India |
Phone |
9769892051 |
Fax |
|
Email |
dr.bhawnasaxena@gmail.com |
|
Source of Monetary or Material Support
|
ITS DENTAL COLLEGE HOSPITAL and RESEARCH CENTRE GREATER NOIDA |
|
Primary Sponsor
|
Name |
ITS Dental college hospital and research centre |
Address |
47 knowledge park III greater noida uttar pradesh |
Type of Sponsor |
Other [Dental College hospital and research centre] |
|
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 Bhawna Saxena |
I.T.S Dental College Hospital and Research Centre |
Department of Pediatric and Preventive Dentistry -Room No. 9 Gautam Buddha Nagar UTTAR PRADESH |
09769892051
DR.BHAWNASAXENA@GMAIL.COM |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
I.T.S. DENTAL COLLEGE HOSPITAL & RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
PHOTOBIOSTIMULATION USING DIODE LASER |
Biolase Epic X diode laser (12J, 0.3 W, 40Sec in pain therapy mode)will be applied at the site where injection for 2% local anesthesia has to be given. |
Comparator Agent |
PHOTOBIOSTIMULATION USING DIODE LASER |
Biolase Epic X diode laser (without activating)will be applied at the site where injection for 2% local anesthesia has to be given in the control side |
Comparator Agent |
TRANSCUTANEOUS ELECTRIC NERVE STIMULATION |
TENS (synapse dental pain eraser) will be applied same as in the intervention without activation of the device in the control side. |
Intervention |
TRANSCUTANEOUS ELECTRIC NERVE STIMULATION |
TENS (Synapse Dental Pain Eraser) will be used for 40 seconds at site where 2% local anesthesia injection has to be given. |
|
Inclusion Criteria
|
Age From |
12.00 Year(s) |
Age To |
16.00 Year(s) |
Gender |
Both |
Details |
1 Patient in ASA-I and ASA-II category.
2 Patients who are undergoing bilateral orthodontic extractions of vital teeth
3 Potentially cooperative patients.
|
|
ExclusionCriteria |
Details |
1. Patients who have dental caries, infection, trauma.
2. Patients with central nervous system disorders, congenital heart diseases and pacemakers.
3. Patient with known allergy to any component of local anaesthesia, electrode/tape/gel.
4. Allergy to light(photosensitivity)
5. Patients with skin conditions (eczema, dermatitis)
6. Patients with open wounds or current or recent bleeding.
7. Patient unwilling to be part of this study
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Anxiety levels will be measured using- Salivary alpha amylase level, salivary pH ,Pulse rate FLACC SCORE FOR PAIN |
Baseline
Pre Operative
Post Operative
|
|
Secondary Outcome
|
Outcome |
TimePoints |
level of pain using FLACC pain score, Salivary alpha amylase, Salivary pH and Pulse rate |
Baseline
preoperative
postoperative
comparision of obtained data |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
15/09/2022 |
Date of Study Completion (India) |
27/02/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Pain management is an important aspect of paediatric dentistry since it influences the patient’s behavior during the session and maintains compliance for future appointments. Local anesthesia (LA) is required for pain relief during a variety of restorative, endodontic, and small surgical treatments. However, the methods used to alleviate pain may be a source of both discomfort and worry in children and youngsters. Increased anxiety can alter a child’s sense of pain, making it more difficult for them to receive the best and most required dental care. The degree of pain associated with local anesthetic administration has been ascribed to a variety of parameters including injection speed, pressure during administration, injection site, pH, volume, and temperature of the anesthetic solution. Pain relief during injection has been recommended using a variety of ways. Reframing, utilizing distractions, and making positive recommendations are examples of behavioral approaches. Other methods include utilizing topical anesthetics prior to the injection, applying lignocaine patches to the gingiva, using electronic dental anesthetic, or using computerized equipment like the Wand to alleviate discomfort. The purpose of this randomized controlled trial is to compare and evaluate the effect of transcutaneous electric nerve stimulation (TENS) and Photobiostimulation using diode laser in reducing pain and anxiety prior to administration of local anesthesia and the effect on duration of onset of local anesthesia in Paediatric patients |