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CTRI Number  CTRI/2024/07/071398 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 03/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   A clinical trial to study the effect of low level laser therapy with Biodentine in patients requiring full pulpotomy in permanent mature teeth 
Scientific Title of Study   Clinical and radiographic evaluation of biodentine and low level laser therapy for full pulpotomy in permanent teeth- A randomized controlled 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  Meba Merin Joy 
Designation  Post Graduate student 
Affiliation  Bapuji Dental College and Hospital 
Address  Room no. 6, Department of Conservative Dentistry and Endodontics, Bapuji Dental College and Hospital, Davangere

Davanagere
KARNATAKA
577004
India 
Phone  8548813846  
Fax    
Email  drmebajoy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Sophia Thakur 
Designation  Professor 
Affiliation  Bapuji Dental College and Hospital 
Address  Room no. 6, Department of Conservative Dentistry and Endodontics, Bapuji Dental College and Hospital, Davangere

Davanagere
KARNATAKA
577004
India 
Phone  9880034125  
Fax    
Email  sophiatwinkles@gmail.com  
 
Details of Contact Person
Public Query  
Name  Meba Merin Joy 
Designation  Post Graduate student 
Affiliation  Bapuji Dental College and Hospital 
Address  Room no. 6, Department of Conservative Dentistry and Endodontics, Bapuji Dental College and Hospital, Davangere

Davanagere
KARNATAKA
577004
India 
Phone  8548813846  
Fax    
Email  drmebajoy@gmail.com  
 
Source of Monetary or Material Support  
Bapuji Dental College and Hospital, Davangere- 577004 
 
Primary Sponsor  
Name  Meba Merin Joy 
Address  Room no.6, Department of Conservative Dentistry and Endodontics, Bapuji Dental College and Hospital, Davangere, Karnataka, India 577004 
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 Meba Merin Joy  Bapuji Dental College and Hospital  Room no. 6, 1st floor, Department of Conservative Dentistry and Endodontics
Davanagere
KARNATAKA 		 8548813846

drmebajoy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Bapuji Dental College and Hospital, Davangere  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  Full pulpotomy using Biodentine   Biodentine will be manipulated according to manufacturers instruction and approximately 2-3mm thick layer of Biodentine will be placed with a plastic instrument.  
Intervention  Photobiomodulation using Low level laser therapy followed by full pulpotomy using Biodentine  The root canal orifices will be exposed to Diode Laser of 660 nm with continuous mode of application for a total duration of approximately 60 sec delivered by 200 microns optical fiber tip which will be kept 1-2mm distance at 200mW power. The photobiomodulation process with low level laser therapy will only be done once(frequency) for a total duration of 60 seconds. Patient and the operator will wear appropriate eye protector during laser application. Biodentine will be manipulated according to the manufacturers instructions and approximately 2-3mm thick layer of Biodentine will be placed with a plastic instrument.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Systemically healthy patients between 18 and 30 years of age
Permanent mandibular first and second molar with mature roots
Dental caries extending greater than or equal to 2/3rd of dentine or exposing the pulp on the radiograph
Clinical diagnosis of irreversible pulpitis with no periapical changes in the radiograph
Bleeding should be controlled in 5 minutes following pulpotomy
Vital bleeding pulp tissue should be present in all canals after complete pulpotomy 
 
ExclusionCriteria 
Details  Presence of sinus tract or swelling
No pulp exposure after caries excavation
Teeth with radiographic signs of internal resorption
Pregnant and lactating mothers 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical and Radiographic evaluation at 6 months interval
Clinical symptoms such as sensitivity, spontaneous pain, tenderness to percussion, draining sinus, swelling and mobility
Radiographic evaluation of periodontal ligament space widening, periapical radiolucency, furcal lesion, internal or external root resorption 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical & Radiographic evaluation at 3 months interval
Clinical symptoms such as sensitivity, spontaneous pain, tenderness to percussion, draining sinus, swelling & mobility
Radiographic evaluation of periodontal ligament space widening, periapical radiolucency, furcal lesion, internal or external root resorption 		 3 months 
Clinical symptoms
Clinical symptoms such as sensitivity, spontaneous pain, tenderness to percussion, draining sinus, swelling & mobility 		 24 hours & after 1 week 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/08/2024 
Date of Study Completion (India) 30/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response (Others) -  Clinical photographs
  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 01-07-2030?
    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 study is a randomized controlled trial evaluating the clinical and radiographic symptoms in full pulpotomy with and without photobiomodulation using low level laser therapy at 3 months and 6 months interval. Following the inclusion and exclusion criteria and obtaining consent from the patients, they will be divided into two groups. in both the groups, caries will be excavated and coronal access will be made under rubber dam isolation.  Primary hemostasis is obtained using 2.5% sodium hypochlorite within 5 minutes. In Group A, 2-3mm thick layer of Biodentine (Septodont, France) is mixed and placed according to manufacturer’s instruction, followed by a layer of resin modified glass ionomer cement and permanent restoration using composite. In Group B, the root canal orifice will be exposed to Diode laser (SiroLaser Blue, Densply Sirona) of 660nm in continuous mode of application for approximately 60 seconds which will be kept at 1-2mm distance at 200 mW power. Both  the operator and the patient will be wearing protective eyewear during the laser application. The rest of the procedures are the same as Group A. Patients will be assessed for clinical symptoms after 24 hours and after 1 week. The primary outcome is the clinical and radiographic analysis which will be done at 3 months and 6 months interval. The patients will be clinically assessed for sensitivity, pain, tender on percussion, draining sinus, swelling and mobility. The radiographic changes such as periodontal ligament space widening, periapical radiolucency, furcal lesion, internal and external root resorption will be assessed. Success will be determined by the absence of symptoms. If failure is diagnose, the tooth will be endodontically treated. 
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