| 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
|
|
|
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
|
|
|
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. |