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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
 
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