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CTRI Number  CTRI/2025/09/094015 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing pain after milk tooth root canal treatment with and without laser light 
Scientific Title of Study   Evaluation of Post Operative Pain with and without Photobiomodulation therapy in Children Aged 4 to 8 Years Undergoing Pulpectomy in Primary Molars: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  Dr Akanksha Dumbare 
Designation  Post Graduate Student 
Affiliation  KLE V.K Institute of Dental Sciences 
Address  Department of Pediatric and Preventive Dentistry, KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9511866136  
Fax    
Email  dumbareakanksha3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shweta Kajjari 
Designation  Reader 
Affiliation  KLE V.K.Institute of Dental Sciences 
Address  Department of Pediatric and Preventive Dentistry, KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9964525733  
Fax    
Email  drshwetakajjari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Akanksha Dumbare 
Designation  Post Graduate Student 
Affiliation  KLE V.K Institute of Dental Sciences 
Address  Department of Pediatric and Preventive Dentistry,KLE V.K Institute of Dental Sciences, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9511866136  
Fax    
Email  dumbareakanksha3@gmail.com  
 
Source of Monetary or Material Support  
KLE V.K Institute of Dental Sciences, Room no. 6, First floor, Department of Pediatric and Preventive Dentistry, Belagavi-590010, Karnataka, India  
 
Primary Sponsor  
Name  Dr Akanksha Dumbare 
Address  Department of Pediatric and Preventive Dentistry, KAHERS KLE V.K Institute of Dental Sciences, Nehru nagar, Belagavi-590010, Karnataka, India 
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 Akanksha Dumbare  KLE V.K Institute of Dental Sciences  Department of Pediatric and Preventive Dentistry, Room no. 6, First floor,KLE V.K Institute of Dental Sciences, Nehru Nagar,Belagavi
Belgaum
KARNATAKA 
9511866136

dumbareakanksha3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics committee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Pulpectomy  Conventional Pulpectomy will be performed with access preparation, canal shaping and cleaning, using 2% chlorhexidine and saline as irrigants. Canals will be obturated with Zinc oxide eugenol on same day. 
Intervention  Pulpectomy with Photobiomodulation therapy as adjunct  Pulpectomy will be performed with access preparation, canal shaping and cleaning, using 2% chlorhexidine and saline as irrigants. GaAlAs semiconductor diode laser of 980 nm with 200mW power in continous mode for duration of 30 secs will be applied at buccal and lingual side periapically. Irradiation in each canal will be carried out with GaAlAs semiconductor diode laser of 980 nm with 200mW power in continous mode for duration of 30 secs. Canals will be obturated with Zinc oxide eugenol on same day. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Patients willing to undergo treatment
Children in the age group of 4 to 8 years
Primary molars with minimum two third of root length remaining,Tooth with history of spontaneous pain
Radiographic evaluation of tooth showing radiolucency involving enamel, dentin, and pulp.
 
 
ExclusionCriteria 
Details  1. Clinically non-restorable teeth.
2. Teeth exhibiting more than one third of physiological/ pathologic root resorption.
3. Children with special health care needs and systemic diseases.
4. Previously endodontically treated teeth.
• Teeth with draining sinus or fistula.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Photobiomodulation therapy may reduce post operative pain following pulpectomy in primary molars in children aged 4 to 8 years  Post operative pain assessment at 24 , 48, and 72 hours using Wong Baker Pain Faces Rating Scale rating 0 to 10 where 0 is no hurt and 10 is hurts worst 
 
Secondary Outcome  
Outcome  TimePoints 
Photo biomodulation therapy may reduce the need of analgesic following pulpectomy in primary molars in children aged 4 to 8 years  Analgesic taken if any will be noted at 24 hr., 42 hr., 72 hr. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 2 
Date of First Enrollment (India)   12/01/2026 
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  

Post-endodontic pain is a common concern in pediatric dentistry, often exacerbated by debris extrusion and anxiety, especially in primary teeth. Photo biomodulation therapy (PBMT) has emerged as a safe, non-invasive method to reduce pain and promote healing by modulating cellular processes and reducing inflammation. This study evaluates the efficacy of PBMT in managing postoperative pain in children aged 4–9 years undergoing pulpectomy, comparing pain levels at 24, 48, and 72 hours using the Wong-Baker Faces Pain Scale. Results aim to enhance pain management in pediatric endodontics. This study aims to evaluate post operative pain with and without Photo biomodulation therapy in children aged 4 to 8 years undergoing pulpectomy in primary molars.  The objective of the study is to evaluate and compare post operative pain with and without Photo biomodulation therapy in children aged 4 to 8 years undergoing pulpectomy in primary molars. 

This is a double arm, parallel group randomized clinical trial evaluating the post operative pain with and without Photo biomodulation therapy in children aged 4 to 8 years undergoing pulpectomy in primary molars. The study will be conducted at the Department of Pediatric and Preventive Dentistry, KAHER’S KLE V. K Institute of Dental Sciences, Belagavi and will include 50 children requiring pulpectomy procedure. The treatment will be carried out under standard operating procedure by Principal Investigator. Patients allotted to group I will be treated with Pulpectomy alone and group II will be treated with Pulpectomy + Photo biomodulation (980nm). Post-operative pain assessment at 24, 48 and 72 hours in both groups using self-administered Wong Baker Faces Pain Rating scale will be done. Further necessary treatment will be provided following standard operating protocol. The expected outcome of study is that Photo biomodulation therapy may reduce post operative pain following pulpectomy in primary molars in children aged 4 to 8 years.

 
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