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CTRI Number  CTRI/2025/04/084356 [Registered on: 08/04/2025] Trial Registered Prospectively
Last Modified On: 07/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical and radiographic success of ProRoot MTA and E-MTA. 
Scientific Title of Study   Comparative Evaluation of Clinical and Radiographic Success Rates of Pro-Root MTA with KIDS E MTA as Apexification agent in Permanent immature Incisors and molars 
Trial Acronym  MTA study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sourabh Ramesh Joshi 
Designation  Professor 
Affiliation  Rural Dental College, Pravara Institute of Medical Sciences, Loni-413736 
Address  Department of Pediatric Dentistry, Rural Dental College, Pravara Institute of Medical Sciences, Loni-413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8698636946  
Fax    
Email  sj3040829@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sourabh Ramesh Joshi 
Designation  Professor 
Affiliation  Rural Dental College, Pravara Institute of Medical Sciences, Loni-413736 
Address  Department of Pediatric Dentistry, Rural Dental College, Pravara Institute of Medical Sciences, Loni-413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8698636946  
Fax    
Email  sj3040829@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sourabh Ramesh Joshi 
Designation  Professor 
Affiliation  Rural Dental College, Pravara Institute of Medical Sciences, Loni-413736 
Address  Department of Pediatric Dentistry, Rural Dental College, Pravara Institute of Medical Sciences, Loni-413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8698636946  
Fax    
Email  sj3040829@gmail.com  
 
Source of Monetary or Material Support  
Rural Dental College, Pravara Institute of Medical Sciences, loni-413736 
 
Primary Sponsor  
Name  Sourabh Ramesh Joshi 
Address  Dept of Pediatric Dentistry, Rural Dental College, Pravara Institute of Medical Sciences, loni-413736  
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 Sourabh Ramesh Joshi  Rural Dental College, Pravara Institute of Medical Sciences, Loni-413736  Dept of Pediatric Dentistry, Rural Dental College, Pravara Institute of Medical Sciences, loni-413736
Ahmadnagar
MAHARASHTRA 
08698636946

sj3040829@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PIMS-DU, Loni  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Total 90 Patients from age group 8-13 years divided in four groups;who have sustained Ellis Class-III or IV fractures in their permanent maxillary incisors and;molars having deep carious lesion  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Apexification   The test groups will be divided into two groups (group 1 & group 2) and will be compared with the control group. So total three groups (2 test groups and 1 control group) will be part of our study. Each group will consist of 30 children. Total sample size will be 90. 
Intervention  Intervention will be apexification procedure in 90 patients   The children will be divided into three main Groups with each group having 30 children in each group. Where Group 1(test) will consist of children having fractured incisors with open apices, Group 2 (test) will consist of children having carious molars with open apices. Group 1 and 2 will be further subdivided into A and B, where subgroup 1A and 2A will be treated with Pro Root MTA and subgroup 1B and 2 B will be treated (15 children in each subgroup) with KIDS e MTA. Group 3 will be a control group where in the apexification procedure with both test materials will be compared with the Calcium hydroxide apexification method. The sample size for the control group will be 30. Clinical and radiographic assessment of both the groups will be carried out at recall periods of 3, 6, and 9 months postoperatively and clinical features such as pain, tenderness to percussion, swelling/intraoral sinus, along with radiographic parameters like calcific bridge formation, periapical radiolucency (if present at baseline), intra-oral/extra oral root resorption will be evaluated. The following measurement methods shall be used for evaluation of pain and periapical radiolucency-: For measuring pain, the Visual Analog Scale (VAS) shall be used, scored from 0 (no pain) to 10 (worst possible pain). For measuring Periapical radiolucency, the Complex Periapical Index (COPI) shall be used, which is composed of three parameters related to characteristics of periapical lesion.  
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  Childrens parent willing to give informed consent will be part of the study.
Children between the ages of eight and thirteen years who have sustained Ellis Class-III or IV fractures in their permanent maxillary incisors
Children between the ages of eight and thirteen years who have deep carious lesion with intact tooth walls.
Children having Spontaneous or night pain, intraoral or extraoral swelling as clinical sign and symptom
Apical diameter in the range of 0.8-1.2mm of open apex molars and incisors will be included in the study 
 
ExclusionCriteria 
Details  Cariously mutilated teeth
Teeth with any developmental anomaly
Teeth with external or internal root resorption
Teeth showing fracture line involving or extending up to the roots
Teeth with root caries
Teeth with cervical abrasion
Teeth with severe mobility grade II or more than grade II mobility were excluded

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
No history of post-operative pain or swelling with the treated tooth/teeth
Reduction in mobility of tooth
 
No history of post-operative pain or swelling with the treated tooth/teeth
Reduction in mobility of tooth
 
 
Secondary Outcome  
Outcome  TimePoints 
Post-operative radiograph showing reduction in size of the radiolucency
No increase in size of radiolucency in post operative radiograph
No PDL widening seen in postoperative radiograph
No external or Internal Resorption seen after Apexification Procedure
 
baseline,3months,6monthsand 9months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   01/05/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

When a tooth has an open apex due to dental trauma or caries, it becomes challenging to achieve a successful root filling during endodontic treatment.

Injuries resulting from trauma are frequently observed during childhood and in toddlers, with a higher susceptibility for upper front teeth to experience fractures.

The closing of the root apex occurs approximately three years after tooth eruption. In cases where the apex remains open due to injury, there may be the presence of residual living pulp tissues and some enduring apical papilla cells in the surrounding periapical tissue.

Apexification, the preferred non-surgical approach for treating necrotic immature permanent teeth, has seen various materials used over time.

Initially, the widely accepted method involved using calcium hydroxide combined with camphorated monochlorophenol to stimulate the development of the apical barrier, as proposed by Kaiser in 1964.

Nevertheless, this substance took nearly 5 to 20 months to create the necessary hard tissue barrier.

Numerous materials have been developed, assessed, and established to achieve optimal results in advanced clinical performance. Mineral trioxide aggregate (MTA) was pioneered by Mahmoud Torabinejad at Loma Linda University in California, USA. Its introduction to the dental field was initially documented by Lee and colleagues in 1993.

Mineral trioxide aggregate (MTA) serves multiple purposes in dentistry, such as functioning as a reparative substance for repairing perforations, as well as being employed in procedures like pulp capping, pulpotomy, creating an apical barrier in cases with open apex, and for retrograde filling.

There have been recent developments in the apexification procedure, where MTA serves as a primary solid block. The gap created due to material shrinkage after placement is now filled with apatite-like deposits that form during MTA maturation. This enhances MTA’s ability to resist friction against root canal walls. MTA stands out for its excellent biocompatibility, reduced cytotoxicity due to its alkaline pH, and has garnered significant attention for its superior sealing capabilities, biocompatibility, regenerative potential, and antibacterial properties. Its formulation containing calcium and phosphate ions promotes the attraction of bone-forming cells and creates a favorable environment for cementum deposition.

Moreover the cost of 1 gram of Pro-Root MTA (USA) is 10000/- , whereas the cost of 1gram E-MTA is 4000/- which is a more economical option. Considering the affordability of the treatment by the patients and Indian Dentists, it is essential to carry out trials comparing the efficacy of new material with the conventional one.

Numerous clinical studies on the use of MTA in apexification can be found in the literature. Limited literature is available comparing E-MTA with Pro Root MTA. The present study aims to evaluate the clinical and radiographic success of E MTA with Pro Root MTA as apexification agents in permanent immature incisors and molars.

 

 
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