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CTRI Number  CTRI/2025/05/087133 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On: 19/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Laser and Conventional Pulpotomy Treatments in Patients with Tooth Pain 
Scientific Title of Study   Comparative Evaluation of Healing Outcomes of LASER and Conventional Pulpotomy in Patients with Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MGM/DCH/IEC/77/1/25  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya Naik 
Designation  Reader 
Affiliation  MGM Dental College and Hospital Kamothe Navi Mumbai 
Address  201 Department of Conservative Dentistry and endodontics MGM Dental college and Hospital kamothe Junction of NH4 and Sion Panvel Hwy Sector 18 Navi Mumbai Maharashtra

Raigarh
MAHARASHTRA
410209
India 
Phone  9967826262  
Fax    
Email  drdolly02@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Divya Naik 
Designation  Reader 
Affiliation  MGM Dental College and Hospital Kamothe Navi Mumbai 
Address  201 Department of Conservative Dentistry and endodontics MGM Dental college and Hospital kamothe Junction of NH4 and Sion Panvel Hwy Sector 18 Navi Mumbai Maharashtra Junction of NH4 and Sion Panvel Hwy Sector 18 Navi Mumbai Maharashtra

Raigarh
MAHARASHTRA
410209
India 
Phone  9967826262  
Fax    
Email  drdolly02@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Divya Naik 
Designation  Reader 
Affiliation  MGM Dental College and Hospital Kamothe Navi Mumbai 
Address  201 Department of Conservative Dentistry and endodontics MGM Dental college and Hospital kamothe Junction of NH4 and Sion Panvel Hwy Sector 18 Navi Mumbai Maharashtra Junction of NH4 and Sion Panvel Hwy Sector 18 Navi Mumbai Maharashtra Junction of NH4 and Sion Panvel Hwy Sector 18 Navi Mumbai Maharashtra

Raigarh
MAHARASHTRA
410209
India 
Phone  9967826262  
Fax    
Email  drdolly02@gmail.com  
 
Source of Monetary or Material Support  
MGM Dental College and Hospital Kamothe Navi mumbai 410209 Maharashtra India 
 
Primary Sponsor  
Name  Dr Divya Naik 
Address  MGM Dental College and Hospital Kamothe Navi Mumbai 410209 
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 Divya Naik  MGM Dental College and Hospital  201 Department of Conservative Dentistry and Endodontics Junction of NH4 and Sion Panvel Hwy Sector 18 Navi Mumbai Maharashtra 410209 India
Raigarh
MAHARASHTRA 
9967826262

drdolly02@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECMGMDCH  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 
Intervention  Laser Pulpotomy  The device used will be a diode laser, Epic X, with a wavelength of 940nm. The procedure will be performed under local anesthesia and rubber dam isolation. The laser energy will be delivered through a 200µm optical fiber tip in a non-contact mode for two to three seconds at intervals of thirty seconds. Laser application will continue until the pulp tissue is completely ablated and hemostasis is achieved.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Participants who accept the study goals and requirements and are willing to participate in the study
All Participants are in good health, based on their written health histories and oral interviews
Participants range in age from 18 to 50 yrs old with both male and female Participants
Participants with moderate to severe pain involving one tooth
All vital teeth with irreversible pulpitis whether associated with or without apical periodontitis
Participant with PAI index score of 1
Thermal and electric pulp tests yielded a positive result
Only teeth with favorable conditions for rubber dam application are considered
Teeth with fully developed apex
Teeth with healthy periodontium with periodontal probing depth less than 3mm
Permanent human teeth
Intact teeth with no cracks or defects
 
 
ExclusionCriteria 
Details  Participants who will not accept the study freely
Participants who do not provide authorization for participation
Participants below 18 years and above 50 years of age
Participants who have taken antibiotics in past 1 month
Participants who have taken analgesic within past 48 hours
Pregnant women and nursing mothers
Participants with non-vital teeth
Participants with acute or chronic dentoalveolar abscess or cellulitis
Participants whose tooth has been accessed previously or endodontically treated
Participants with inflamed pulp in which bleeding could not be controlled within 10 minutes
Participants who have taken medications which in the opinion of the investigator could interfere with the conduct of the study eg corticosteroids antibiotics and analgesics in the past month
Participants with known systemic disorders or immunocompromised conditions eg diabetes AIDS
Participants who have a current or recent history of alcohol or other substance abuse
Participants with PAI index score
Participants with an intraoral and extraoral sinus tract
Teeth with aggressive periodontitis and grade III mobility periodontal probing depth greater than 3mm
Severe labially or lingually malposition teeth in which clinical access will be difficult
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluate the healing outcomes of laser pulpotomy compared with conventional pulpotomy in the management of patients with symptomatic irreversible pulpitis.
 
1 year follow up
 
 
Secondary Outcome  
Outcome  TimePoints 
outcome of radiographic success will be classified using a Orstavik’s Periapical Index score (PAI). teeth with normal contour or width of PDL will be deliberated as success, and teeth with periapical radiolucency will be reported as failure.
 
1 year followup 
the preoperative and post-operative pain levels will be recorded by using a visual analogue scale (VAS).
 
The post operative pain levels will be recorded at intervals of 6 hours, 24 hours, and 7 days after the initial visit.
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3 
Date of First Enrollment (India)   01/07/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - 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
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 - Proposals should be directed to [drdolly02@gmail.com].

  6. For how long will this data be available start date provided 01-07-2027 and end date provided 01-07-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This randomized controlled trial investigates the comparative healing outcomes of diode laser pulpotomy versus conventional pulpotomy in mature permanent teeth diagnosed with symptomatic irreversible pulpitis. As a vital pulp therapy (VPT) technique, pulpotomy has gained traction as a minimally invasive alternative to root canal therapy (RCT), aiming to preserve pulpal vitality while reducing procedural complexity, treatment costs, and patient discomfort.

                                   The diode laser offers unique benefits, including precise tissue ablation, effective hemostasis, and antibacterial properties, potentially minimizing bleeding, bacterial contamination, and mechanical damage during the procedure. Conventional pulpotomy, on the other hand, relies on well-established protocols, including the use of sodium hypochlorite for hemostasis and materials like mineral trioxide aggregate (MTA) for pulp sealing and healing.

                                          Key objectives of the study include assessing the clinical and radiographic success rates of both techniques, evaluating postoperative pain levels, and analyzing healing dynamics over time. Additionally, the study examines whether diode laser pulpotomy offers a more efficient and predictable approach to managing irreversible pulpitis or if conventional pulpotomy remains the standard of care.

                                   The findings aim to provide clarity on the optimal approach for treating symptomatic irreversible pulpitis in mature permanent teeth, potentially influencing clinical guidelines, improving patient outcomes, and expanding treatment options beyond traditional root canal therapy.

 

 
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