| CTRI Number |
CTRI/2025/07/090359 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Closure of tooth root tip and root lengthening with MTA and Biodentine cements assisted by laser |
|
Scientific Title of Study
|
Laser assisted Modified Apexification procedure for immature non-vital 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 Shrutha S P |
| Designation |
Professor |
| Affiliation |
AMEs dental college hospital and research center |
| Address |
Room No 4, Department of pedodontics and preventive dentistry, AMEs dental college hospital and research center, Raichur, Karnataka, India
Raichur
KARNATAKA
584103
India |
| Phone |
9483329406 |
| Fax |
|
| Email |
shruthavinit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra Havale |
| Designation |
Professor and HOD |
| Affiliation |
AMEs dental college hospital and research center |
| Address |
Room No 4, Department of pedodontics and preventive dentistry, AMEs dental college hospital and research center, Raichur, Karnataka, India
Raichur
KARNATAKA
584103
India |
| Phone |
9448407300 |
| Fax |
|
| Email |
raghavendrahavale@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanchan M Tuppadmath |
| Designation |
Senior Lecturer |
| Affiliation |
AMEs dental college hospital and research center |
| Address |
Room No 4, Department of pedodontics and preventive dentistry, AMEs dental college hospital and research center, Raichur, Karnataka, India
Raichur
KARNATAKA
584103
India |
| Phone |
9686984929 |
| Fax |
|
| Email |
kanchantuppadmath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences, 4rth T block, Jayanagar, Bengaluru- 560041, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health Sciences |
| Address |
Rajiv Gandhi University of Health Sciences, Jayanagar-4rth block, Bangalore 560041, Karnataka, India. |
| Type of Sponsor |
Other [University] |
|
|
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 Shrutha S P |
AMEs dental college hospital and research center |
Room No 4, Department of pedodontics and preventive dentistry, AMEs dental college hospital and research center, Raichur, Karnataka, India
Raichur
KARNATAKA |
9483329406
shruthavinit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee for AMEs dental college hospital and research center, raichur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, (2) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biodentine |
As an apexification agent in Laser assisted modified apexification in enhancing the root length and root canal dentin width in non vital teeth follow up done for 18 months with follow visits at 6th month, 12 month, 18 month post procedure |
| Comparator Agent |
MTA |
As an apexification agent in Laser assisted modified apexification in enhancing root length and root canal dentin width in non vital teeth follow up done for 18 months, with follow visits at 6 month, 12 month and 18 month |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
immature teeth with necrotic pulp
Children with Frankl behavior rating 3,4 |
|
| ExclusionCriteria |
| Details |
special children
Medically compromised children
Children with Frankl behavior rating 1,2
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Biodentine is superior than MTA |
6months, 12 months, 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Comparative evaluation of Laser assisted modified apexification for immature non-vital teeth with MTA and Biodentine will be done in 18 months of time for root lengthening and root canal dentin thickness ( Radiographic area) with 50 samples allocated to 25 for each group with lottery method. Prior commencing the study ethical clearance is taken and informed /proxy consent will be taken by participant. Before starting the procedure pre operative CBCT scan will be done to assess the root length and development. Modified apexification is done with laser disinfection and apical collagen and 3-4mm of apical plug is placed with MTA/Biodentine later, canal space is filled with flowable guttapercha after placing sealer. Post procedure periapical PBM is done at 1st, 3rd, 5th days. CBCT assessment will be done at 6months, 12months, 18months for root length and Radiographic root area. |