| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [priyabalu1907@gmail.com].
- 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.
- 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. |