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CTRI Number  CTRI/2025/08/092270 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 23/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Radiation Therapy
Dentistry
Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to compare which amongst the two reduces the needle pain in children while giving inferior alveolar nerve block. Laser therapy or topical anesthetic spray.  
Scientific Title of Study   Comparative evaluation of Low Level Laser Therapy (LLLT)and topical LA spray in reducing needle prick pain during inferior alveolar nerve block in pediatric patients- a randomized control 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  Dr Sadanand Kulkarni 
Designation  Professor and Head of Department 
Affiliation  Martha Mandals N G H Institute of Dental Sciences and Research Centre 
Address  Maratha Mandal’s institute of dental sciences and research centre. Department of Pediatric and Preventive Dentistry. room no 07. 47 A/2 Bauxite road, Near KSRP ground, Belagavi ,Karnataka 590010
Maratha Mandal’s institute of dental sciences and research centre. Department of Pediatric and Preventive Dentistry. room no 07. 47 A/2, Bauxite road, Sadashiv Nagar, near KSRP ground, Belagavi, Karnataka
Belgaum
KARNATAKA
590019
India 
Phone  9977416975  
Fax    
Email  drsadanandkulkarni@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sadanand Kulkarni 
Designation  Professor and Head of Department 
Affiliation  Martha Mandals N G H Institute of Dental Sciences and Research Centre 
Address  Martha Mandals N G H Institute of Dental Sciences and Research Centre. Room no 07, Dept of Pediatric and Preventive Dentistry. 47 A/2, Bauxite road, Sadashiv Nagar, near KSRP ground, Belagavi, Karnataka
47 A/2, Bauxite road, Sadashiv Nagar, near KSRP ground, Belagavi, Karnataka
Belgaum
KARNATAKA
590019
India 
Phone  9977416975  
Fax    
Email  drsadanandkulkarni@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sadanand Kulkarni 
Designation  Professor and Head of Department 
Affiliation  Martha Mandals N G H Institute of Dental Sciences and Research Centre 
Address  Martha Mandals N G H Institute of Dental Sciences and Research Centre. Room no 07. Dept of Pediatric and Preventive Dentiatry. 47 A/2, Bauxite road, Sadashiv Nagar, near KSRP ground, Belagavi, Karnataka
47 A/2, Bauxite road, Sadashiv Nagar, near KSRP ground, Belagavi, Karnataka
Belgaum
KARNATAKA
590019
India 
Phone  9977416975  
Fax    
Email  drsadanandkulkarni@hotmail.com  
 
Source of Monetary or Material Support  
Martha Mandals N G H Institute of Dental Sciences and Research Centre. Room no 07. Dept of Pediatric and Preventive Dentiatry. 47 A/2, Bauxite road, Sadashiv Nagar, near KSRP ground, Belagavi, Karnataka 
 
Primary Sponsor  
Name  Dr Aparna Rayamane 
Address  Martha Mandals N G H Institute of Dental Sciences and Research Centre. Room no 07. Dept of Pediatric and Preventive Dentiatry. 47 A/2, Bauxite road, Sadashiv Nagar, near KSRP ground, Belagavi, Karnataka 
Type of Sponsor  Other [self] 
 
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 Sadanand Kulkarni  maratha mandals N G H Institue of dental sciences and research centre  Room no 07. Dept of Pediatric and Preventive Dentiatry. 47 A/2, Bauxite road, Sadashiv Nagar, near KSRP ground, Belagavi, Karnataka
Belgaum
KARNATAKA 		 9977416975

drsadanandkulkarni@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maratha Mandals N G H Institute of Dental Sciences and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  LA spray  topical LA spray of Nummit spray- 15% lignocaine spray with 1:80,000 adrenaline 
Intervention  Low level laser therapy  Low level laser therapy of 810 nm wavelength diode laser  
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Patients whose parents assent to participate in the study voluntarily
Patients of age group between 7 to 11 years
Patients indicated for bilateral extraction of lower teeth and requiring same LA technique
Patients with Frankles positive and definitely positive behaviour rating
Patients undergoing the treatment of extraction for the first time
Children who are not on any medication
Patients who are not suffering from any systemic illness
 
 
ExclusionCriteria 
Details  Patients who are allergic to LA
Patients who are showcasing local inflammation or tenderness at the site of LA
Patients who are suffering from systemic illness and are on any drugs
Patients who are not willing to participate in the study
Patients with Frankle negative and definitely negative behaviour rating
Patients who have already undergone the treatment of extraction before
Patients who are unfit to meet any of the above mentioned criteria
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Low Level Laser Therapy reduces needle prick pain during inferior alveolar nerve block in children  immediately after giving LA 
 
Secondary Outcome  
Outcome  TimePoints 
positive behaviour and faster and successful dental treatment for child  baseline 2 visits 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/08/2025 
Date of Study Completion (India) 23/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rayamane52102a@gmail.com].

  6. For how long will this data be available start date provided 18-07-2025 and end date provided 19-06-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This is as split mouth design study involving 30 children aged 7to 11 years requiring bilateral extraction of mandibular teeth. After obtaining informed consent  eligible participants will be randomly allocated using the SNOSE technique. One side will receive Low Level Laser Therapy  with 810 nm radiation at the local anesthesia site  and the other side will serve as control receiving inactive laser and topical anesthetic spray. A placebo cotton pellet dipped in cold water will mimic the spray effect on the experimental side. Standardized extraction procedures and postoperative analgesics will be given. Pain perception will be evaluated immediately after LA administration using a 10 cm Visual Analog Scale, ranging from 0 with no pain to 10 with severe pain. 
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