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CTRI Number  CTRI/2025/07/090099 [Registered on: 03/07/2025] Trial Registered Prospectively
Last Modified On: 02/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Various tooth medicament filling material comparison 
Scientific Title of Study   Comparative evaluation of laser activated collagen and Light cure MTA as a novel pulpotomy agent: 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 Kashyap B 
Designation  Student 
Affiliation  AME Dental College Raichur,Karnataka,India 
Address  Room number 4, Department of Pedodontics, AME Dental College, Bijangera road, RAICHUR

Raichur
KARNATAKA
584103
India 
Phone  9481682945  
Fax    
Email  kashyapkannanth@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Raghavendra Havale 
Designation  Head of the depar 
Affiliation  AME Dental College Raichur,Karnataka,India 
Address  Room number 4, Department of Pedodontics, AME Dental College, Bijangera road, RAICHUR

Raichur
KARNATAKA
584103
India 
Phone  9448407300  
Fax    
Email  raghavendrahavale@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR PRAVEEN KUMAR N H 
Designation  Reader 
Affiliation  AME Dental College Raichur,Karnataka,India 
Address  Room number 4, Department of Pedodontics, AME Dental College, Bijangera road, RAICHUR

Raichur
KARNATAKA
584103
India 
Phone  9538623728  
Fax    
Email  drpraveennh@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Kashyap B 
Address  Room number 4, Department of Pedodontics, AME Dental College, Bijangera road, RAICHUR - 584103 
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 Kashyap B  AME Dental College Raichur.  Room number 4, Department of Pedodontics, AME Dental College, Bijangera road, RAICHUR -584103
Raichur
KARNATAKA 
9481682945

kashyapkannanth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for AME denatl college   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  Laser activated collagen  It is given as pulpotomy agent and measured every 3 months for 1 year 
Intervention  Light cure MTA  It is given as pulpotomy agent and measured every 3 months for 1 year 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  An age range of 4-8 years,Lower right/left first/ second primary molars with reversible pulpitis, Carious/mechanical pulp exposure, No clinical or radiographic sign of pulp pathoses, Deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically
 
 
ExclusionCriteria 
Details  History of spontaneous and unprovoked pain, Mobility, Sensitive to percussion, Any sign of Presence of fistulae, external or internal root resorption, carious furcation involvement, and periapical lesion, Dystrophic calcification of the pulp
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the clinical and radiographic success of Laser-Enhanced Collagen and Light-Cured MTA pulpotomy procedures at specified follow-up intervals.  at 1 month, 3 months, 6 months, 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) 27/05/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
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 - NO
Brief Summary  

After the selection of participants, the procedure will begin with administration of local anesthesia and the teeth will be isolated. The soft carious lesions will be first excavated using a spoon excavator, followed by which access opening will be performed using a high-speed bur with the aerator. Following the initial drop into the pulp chamber, the tooth will be reassured by operative diagnosis by analyzing the nature of the pulpal bleeding. Following the Satisfactory operatory diagnosis, the treatment will be continued, the pulp chamber will be completely deroofed, the coronal portion of the pulp will be removed with the intact untouched radicular pulp, and finally, irrigation will be done with saline to remove the dentinal debris. A cotton pellet dipped with saline will be placed over the root canal orifice to attain hemostasis, followed by which Light cure MTA pulpotomy and Laser enhanced collagen-based pulpotomy will be carried in their respective groups. After the pulpotomy procedures the tooth will be restored with the Stainless steel crowns.

Follow up will be done at 1 month, 3 month, 6 months and 12 months. At each time period clinical (pain, tenderness to percussion, abscess, swelling, fistula, and pathologic mobility) and radiographic analysis(radicular radiolucency, internal and external root resorption, periodontal ligament space widening, and furcation radiolucency) will be made.

 
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