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CTRI Number  CTRI/2025/06/089751 [Registered on: 27/06/2025] Trial Registered Prospectively
Last Modified On: 13/01/2026
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 Two Laser Treatments and a Regular Method for Cleaning Infected Permanent Teeth" 
Scientific Title of Study   A Comparative Evaluation of Two Different Diode Laser Wavelengths and Conventional Root Canal Disinfection in Pulp Regeneration of Necrotic Immature 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  Dr Priyanka B 
Designation  Senior Lecturer 
Affiliation  Chettinad Dental College and Reseach Institute  
Address  Room no 6, Third floor, E block,Department of Pediatric and Preventive Dentistry, Chettinad dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai - 603103

Kancheepuram
TAMIL NADU
603103
India 
Phone  8838603094  
Fax    
Email  priyabalu1907@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka B 
Designation  Senior Lecturer 
Affiliation  Chettinad Dental College and Reseach Institute  
Address  Room no 6, Third floor, E block,Department of Pediatric and Preventive Dentistry, Chettinad dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai - 603103

Kancheepuram
TAMIL NADU
603103
India 
Phone  8838603094  
Fax    
Email  priyabalu1907@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Priyanka B 
Designation  Senior Lecturer 
Affiliation  Chettinad Dental College and Reseach Institute  
Address  Room no 6, Third floor, E block,Department of Pediatric and Preventive Dentistry, Chettinad dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai - 603103

Kancheepuram
TAMIL NADU
603103
India 
Phone  8838603094  
Fax    
Email  priyabalu1907@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateswara Dental College and Hospital, Thalambur, Navallur. 
 
Primary Sponsor  
Name  Dr Priyanka B 
Address  Room no 6, Third floor, E block,Department of Pediatric and Preventive Dentistry, Chettinad dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai - 603103 
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 Priyanka B  Chettinad Dental College and Research Institute   Room no 6, Third floor, E block,Department of Pediatric and Preventive Dentistry, Chettinad dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam, Chennai - 603103
Kancheepuram
TAMIL NADU 
8838603094

priyabalu1907@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee - Chettinad Dental College and Research Institute (IHEC-CDCRI)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laser-Assisted Disinfection - 810 NM   After access opening and pulp extripation, a 810 NM laser with an optical tip 1 mm short of the working length will be used to disinfect the canal.  
Intervention  Laser-Assisted Disinfection - 980 NM  Access Opening and pulp extripation, 980 NM laser with an optical tip 1 mm short of the working length will be used to disinfect the canal 
Comparator Agent  Triple Antibiotic Paste   After access opening and pulp extripation, a triple antibiotic paste (composed of ciprofloxacin, metronidazole, and minocycline in a 1:1:1 ratio) will be placed into the canal before the revascularisation procedure is started. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. subjects who come under ASA I for children
2. children of both genders with an age range from 7 to 9 years
3. The tooth in question is in a restorable state
4. Permanent necrotic central incisors with incomplete root development defined by apical foramen size greater than 1 mm
5. young permanent teeth with or without periapical lesion
pulp involvement due to trauma selected teeth have never been 6. subjected to any line of endodontic treatment  
 
ExclusionCriteria 
Details  1. root resorption , ankylosis and root fracture
2. uncooperative patients
3. legal guardians did not consent to participate in the study
4. presence of draining sinus and presence of periodontal pockets,
5. presence of periapical radiolucency more than 10mm measured using DBSWIN software tool 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The Radiographic Success Rate will be assessed Root-width/legth ratio, Nollas stage of tooth development, Dentin wall thickness, Root Length, apical diameter, diameter of the periapical radiolucency if present, perforation if present   All the above parameters will be assessed at baseline, 3rd, 6th and 12th months interval using cbct and rvg alternatively  
 
Secondary Outcome  
Outcome  TimePoints 
the clinical success rate will be assessed Vitality, post operative pain, swelling, tooth discolouration, mobility and tender on percussion.   All the above parameters will be assessed at baseline, 3rd, 6th and 12th months interval 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   27/07/2025 
Date of Study Completion (India) 13/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
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 - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [priyabalu1907@gmail.com].

  6. For how long will this data be available start date provided 30-06-2025 and end date provided 20-06-2030?
    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 clinical trial aims to evaluate and compare the clinical, radiographic, and antimicrobial efficacy of three different root canal disinfection protocols—Triple Antibiotic Paste (TAP), 810 nm diode laser, and 980 nm diode laser—in the context of pulp revascularization for necrotic immature permanent anterior teeth in children. Pulp revascularization, a regenerative endodontic approach, offers a biologically based treatment for teeth with open apices. The success of this technique depends heavily on effective disinfection while preserving the viability of stem cells in the apical papilla.

The study will involve 30 children aged 7–9 years with non-vital, immature maxillary central incisors. Participants will be randomly divided into three groups (n=10 per group). Group 1 will receive TAP for 3 weeks; Group 2 will undergo disinfection using an 810 nm diode laser; Group 3 will receive 980 nm diode laser treatment. Microbial samples will be collected pre- and post-disinfection to evaluate the reduction in colony-forming units (CFUs). All groups will follow the American Association of Endodontists (AAE) 2021 protocol for regenerative endodontics.

Clinical and radiographic outcomes, including root length, dentin wall thickness, apical closure, and post-operative symptoms, will be assessed at 3, 6, 9, and 12 months. A final CBCT scan at 12 months will help evaluate root development and healing. Statistical analysis will be performed using SPSS v25, with appropriate tests based on data distribution.

This study is expected to provide valuable insights into the most biologically favorable and clinically effective disinfection strategy for regenerative endodontics. The findings will contribute to improved protocols for managing necrotic immature permanent teeth in pediatric patients, enhancing both treatment success and long-term prognosis. Ethical clearance has been obtained for this low-risk clinical trial involving children and minimally invasive procedures.

 
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